[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sir Mortimer B. Davis - Jewish General Hospital\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":501},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,18,0,[8,56,84,105,132,155,179,216,241,278,310,342,362,383,414,436,455,476],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":34,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":55},"100289723","phase-2-randomizing-two-radiotherapy-boost-options-to-avoid-rectal-cancer-surgery-100289723",false,"NCT03051464","Randomizing Two Radiotherapy Boost Options to Avoid Rectal Cancer Surgery","A Phase III Study Testing Two Dose Escalation Strategies to Increase the Population of Complete Responders After Radiation Therapy in the Context of Organ Preservation for Patients With Rectal Cancer","MORPHEUS","Inclusion Criteria:\n\n* Rectal cancer patients, clinically staged as T2-T3a,b N0-1 by MRI or endoscopic\u002Ftrans-rectal ultrasound\n* Rectal cancer staged as N0-1 by MRI or EUS\u002FTRUS\n* No metastatic lesion\n* Rectal tumor occupying less than half of the circumference\n* Tumor less than 5 cm on its largest dimension\n* Tumor located at less than 10 cm from the anal verge\n* Tumor penetration less than 5 mm in the mesorectal fat\n* Tumor accessible for brachytherapy\n* Lumen accessible for colonoscopy\n* Patient should be a suitable candidate for brachytherapy and chemotherapy\n* Older than 18 years of age\n* Adequate birth control measures in women of childbearing potential\n* Written informed consent\n\nExclusion Criteria:\n\n* Patients with previous pelvic radiation\n* Evidence of distant metastasis\n* Extension of malignant disease to the anal canal\n* Tumors staged as T4\n* Tumors larger than 5 cm in length","ALL","18 Years","80 Years",{"count":21,"type":22},131,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE2","PHASE3","A randomized study of 131 patients. Patients with a clinical T2-3 N0-1 rectal cancer will be randomized to two arms (arm A: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy compared to arm B: standard chemoradiation (45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions).",[29,30,31,32,33],"Stage II Rectal Cancer","Organ Preservation","Non-operative Treatment","Rectal Cancer (Stage III)","Rectal Cancer Patients",[35,36,37,38,39,40,41,42],"rectal cancer","non-operative management","rectal preservation","organ preservation","brachytherapy boost for rectal cancer","low rectal cancer curative treatment","mid rectal cancer curative treatment","rectal brachytherapy","RECRUITING","2026-06-25",{"date":46,"type":47},"2026-06-30","ACTUAL",{"date":49,"type":47},"2017-04-25",{"date":51,"type":22},"2030-01",{"name":53,"class":54},"Sir Mortimer B. Davis - Jewish General Hospital","OTHER",4,{"id":57,"slug":58,"hasResults":11,"nctId":59,"briefTitle":60,"officialTitle":61,"acronym":62,"eligibilityCriteria":63,"healthyVolunteers":64,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":65,"targetDuration":67,"studyType":68,"phases":4,"briefSummary":69,"conditions":70,"keywords":72,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100433517","tradeoffs-in-patient-decision-making-about-rectal-cancer-treatment-benefits-compared-to-quality-of-life-100433517","NCT04925154","Tradeoffs in Patient Decision Making About Rectal Cancer Treatment: Benefits Compared to Quality Of Life.","PATHOS Tradeoffs in Patient Decision Making About Rectal Cancer Treatment: Benefits Compared to Quality Of Life.","Pathos","Inclusion Criteria:\n\nGroup A\n\n* New rectal cancer patient\n* Operable patients\n* Capable adults older than 18 years of age\n* Capacity to sign a consent form\n* Capacity to answer questionnaires on an online platform Group B\n* Treating physician specialists\n* Capacity to sign a consent form\n* Capacity to answer questionnaires on an online platform\n\nExclusion Criteria:\n\nGroup A:\n\n* Patient unable to sign a consent form\n* Patients with metastasis\n* Recurrent tumours\n* Inability to answer questionnaires on an online platform\n* Inability to communicate in french or english\n\nGroup B:\n\n* Participant unable to sign a consent form\n* Inability to answer questionnaires on an online platform",true,{"count":66,"type":22},192,"3 Weeks","OBSERVATIONAL","This study is aiming to look into patients' treatment preferences and their socio economic background as well as the exploration of thought processes leading to these preferences. It will integrate, in two exploratory questionnaires, the three most common treatment schema (standard of care, non-operative management, surgery alone) all of which have been demonstrated efficacious.",[71],"Patient Preference",[73,74],"Colorectal cancer","Treatment preferences","2026-05-11",{"date":77,"type":47},"2026-05-14",{"date":79,"type":47},"2021-12-13",{"date":81,"type":22},"2028-01-01",{"name":53,"class":54},1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":4,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":23,"phases":93,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":83},"100234690","grid-therapy-as-palliative-radiation-for-patients-with-advanced-and-symptomatic-tumors-100234690","NCT02333110","GRID Therapy as Palliative Radiation for Patients With Advanced and Symptomatic Tumors","Spatially Fractionated Radiation (SFR) Therapy as Palliative Radiation for Patients With Advanced and Symptomatic Tumors","Inclusion Criteria:\n\n* Patient with histologically or cytologically confirmed malignancy. All malignant histologies\u002Fcytologies are eligible.\n* Patient with bulky tumor (larger than 8cm), or with a tumor known to be resistant to radiation (eg. Melanoma, hypernephroma, sarcoma), or with a tumor previously irradiated with a palliative intent requiring more than 1 fraction of radiation\n* Patient planned to undergo palliative radiation therapy treatments to one of the following 5 sites: extremities, neck, chest, abdomen and pelvis\n* WHO performance status of 0-2\n* Aged 18 years or older\n* Ability to sign and understand an informed consent form\n\nExclusion Criteria:\n\n* Potentially curable patient\n* Previous palliative radiation with hypofractionation\n* Tumor located near the spinal cord or in the brain\n* Pregnant or nursing woman",{"count":92,"type":22},50,[94],"NA","Palliative radiation therapy represents 40% of the on-going radiation at the Jewish General Hospital. In a traditional palliative radiation treatment to bulky or radioresistant tumors, radiotherapy schema varies from 24 to 30 Gys given in 3 to 10 fractions, depending on the tumor size, tumor location and tumor pathology. However, for many patients this treatment involves considerable toxicity, travel and time spent at the hospital. Spatially fractionated radiation (SFR) is an alternative technique that consists in delivering one single treatment, given through a grid containing holes. The present study is proposing to validate SFR as a safe and effective mean to palliate patients with symptomatic bulky tumors (more than 8 cm) or with tumors known to be resistant to radiation.",[97],"Patients With Symptomatic or Bulky Tumors (More Than 8 cm) or With Tumors Resistant to Radiation",{"date":99,"type":47},"2026-05-12",{"date":101,"type":4},"2015-01",{"date":103,"type":22},"2027-12",{"name":53,"class":54},{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":64,"sex":17,"minAge":18,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":23,"phases":116,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":83},"100618967","cardiovascular-effects-of-music-versus-guided-mindfulness-100618967","NCT07338500","Cardiovascular Effects of Music Versus Guided Mindfulness","Cardiovascular Effects of Music Versus Guided Mindfulness: A Randomized Crossover Study","CMM","Inclusion Criteria:\n\n* Normal baseline blood pressure (systolic BP \\\u003C 120 mmHg and diastolic BP \\\u003C 80mmHg).\n* Abstention from caffeine intake for at least 12 hours before the study session and throughout the session, as caffeine may influence cardiovascular measurements.\n* Abstention from using nicotine or tobacco products for at least 1 hour before the study session and throughout the session, as these substances may influence cardiovascular measurements.\n\nExclusion Criteria:\n\n* Significant hearing impairments that cannot be improved with hearing aids or sound amplification.\n* Current use of medications that could affect blood pressure.\n* History of hypertension or cardiovascular disease.\n* Diagnosis of active substance use disorder, or reported patterns of alcohol, cannabis, or recreational\u002Fnon-prescribed substance use likely to affect cardiovascular function.","75 Years",{"count":115,"type":22},30,[94],"The purpose of this study is to examine how listening to music compares to guided mindfulness in affecting blood pressure, heart rate, and feelings of anxiety in healthy adults. The investigators aim to determine whether one of these approaches is more effective in reducing these variables. Additionally, the study will explore whether personal traits or preferences, measured using questionnaires, influence how participants respond to music or mindfulness. Based on previous clinical findings, the researchers hypothesize that listening to music will lead to greater reductions in blood pressure and heart rate compared to guided mindfulness.",[119,120],"Music Listening Intervention","Mindfulness-based Intervention",[122,123],"Music","Mindfulness","2026-04-21",{"date":126,"type":47},"2026-04-24",{"date":128,"type":47},"2026-04-10",{"date":130,"type":22},"2026-08",{"name":53,"class":54},{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":23,"phases":142,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":4},"100634361","vr-study-virtual-reality-for-patients-during-arteriovenous-fistula-surgery-100634361","NCT07538687","VR Study Virtual Reality for Patients During Arteriovenous Fistula Surgery","Virtual Reality for Patients During Arteriovenous Fistula Surgery: A Randomized Controlled Trial","VR","Inclusion Criteria:\n\n* Adults aged ≥18 years scheduled for elective arteriovenous fistula (AVF) creation surgery.\n* Diagnosed with End-Stage Renal Disease (ESRD) and indicated for hemodialysis access.\n* Able to provide informed consent and understand study procedures.\n* Medically stable and cleared for surgery by the anesthesia and surgical teams.\n* Able to wear a virtual reality headset (e.g., no severe claustrophobia or facial injuries preventing use).\n\nExclusion Criteria:\n\n* Patients with a history of seizure disorders or epilepsy triggered by visual stimuli.\n* Severe motion sickness, vertigo, or vestibular disorders that may be exacerbated by virtual reality.\n* Significant cognitive impairment or inability to understand instructions or complete questionnaires.\n* Facial or cranial abnormalities or injuries that prevent proper fitting of the VR headset.\n* Patients requiring general anesthesia.",{"count":141,"type":22},64,[94],"Patients undergoing arterio-venous fistula commonly experience pain and anxiety due to their pre-operative circumstances and the fact that they remain conscious throughout the surgery. It is well documented that perioperative pain and anxiety can cause detrimental effects on patient outcomes and satisfaction. Virtual reality (VR) is increasingly being investigated as an adjunctive tool in various medical and surgical specialties. Current Evidence suggests that VR can be effective in managing both acute and chronic pain, as well as reducing pain, anxiety, stress, and the need for anesthetic agents during surgery. We hypothesize that using VR during AVF surgery will lead to a reduction in anesthetic doses, decreased patient anxiety and pain, and be favorably received by both surgeons and anesthetists.",[145],"End Stage Renal Disease on Dialysis","NOT_YET_RECRUITING","2026-04-15",{"date":149,"type":47},"2026-04-20",{"date":151,"type":22},"2026-06-01",{"date":153,"type":22},"2028-12-01",{"name":53,"class":54},{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":163,"minAge":18,"maxAge":4,"enrollmentInfo":164,"targetDuration":4,"studyType":23,"phases":166,"briefSummary":167,"conditions":168,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":83},"100607400","a-study-looking-at-a-new-nerve-surgery-to-help-men-regain-erections-after-prostate-cancer-surgery-100607400","NCT07188064","A Study Looking at a New Nerve Surgery to Help Men Regain Erections After Prostate Cancer Surgery","Prospective Cohort Study of Somatic-Autonomic Nerve Grafting Technique to Restore Erectile Function in Patients With Persistent Erectile Dysfunction Post Radical Prostatectomy","PRP NG PRO M","Inclusion Criteria:\n\n* Patients with persistent post prostatectomy erectile dysfunction as defined below:\n\n  1. Severe ED (IIEF score 5-7) and more than 12 months from prostatectomy OR\n  2. Moderate ED (IIEF score 8-11) and more than 18 months from prostatectomy\n* Patients must have had good pre-prostatectomy erectile function with a baseline IIEF score of ≥17 on self-reported assessment of historic function.\n\nExclusion Criteria:\n\n* Patients aged \\\u003C 18 years at diagnosis\n* Legally incapable patients\n* Patients \\>5 years from prostatectomy.\n* Bilateral open inguinal hernia repair\n* Patients with pre-existing significant neurologic disease\n* Diabetes with evidence of peripheral nerve involvement and end organ dysfunction\n* Coronary artery disease with unstable angina\n* Mood disorder (anxiety\u002Fdepression) with change in medical therapy within last 3 months\n* Pre-existing penile base surgery which would prevent grafting technique including suprapubic liposuction, suspensory ligament release\n* Pre-existing penile prosthesis\n* Current use of androgen deprivation therapy\n* Use of medications for chronic nerve pain (gabapentin, amitriptyline, nortriptyline, pregablin)\n* Previous untreated penile trauma\n* Patients deemed medically unfit for surgery","MALE",{"count":165,"type":22},100,[94],"A single arm prospective pilot trial evaluating the 1-year erectile recovery outcomes and the safety of patients undergoing a somatic to autonomic nerve grafting procedure for restoration of erectile function in patients who have lost erectile function following radical prostatectomy for prostate cancer. During this study a total of 100 patients who have persistent erectile dysfunction for more than 18 months post prostatectomy will undergo a post radical prostatectomy nerve restoration procedure (PRP-NR).",[169,170],"Prostate Cancer","Erectile Dysfunction Following Radical Prostatectomy","2026-03-07",{"date":173,"type":47},"2026-03-10",{"date":175,"type":47},"2026-01-30",{"date":177,"type":22},"2028-12",{"name":53,"class":54},{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":64,"sex":17,"minAge":18,"maxAge":187,"enrollmentInfo":188,"targetDuration":190,"studyType":68,"phases":4,"briefSummary":191,"conditions":192,"keywords":197,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":215,"locationsCount":83},"100449993","montreal-immune-related-adverse-events-mirae-study-100449993","NCT05139706","Montreal Immune-Related Adverse Events (MIRAE) Study","Montreal Database and Biorepository of Cancer Patients Treated With Immune Checkpoint Inhibitors for the Study of Immune-related Adverse Events","MIRAE","Inclusion Criteria:\n\n* \\>= 18 years of age\n* cancer patients treated with ICI therapy (e.g., anti-CTLA-4, anti-PD-1, anti-PD-L1, and combinations)\n* patients with primary autoimmune or autoinflammatory diseases that resemble immune-related adverse events (irAEs)\n* healthy volunteers with non-inflammatory disorders, and without any history of cancer\n\nExclusion Criteria:\n\n* Participants not able to provide informed consent","100 Years",{"count":189,"type":22},1000,"60 Months","Immune checkpoint inhibitors (ICI) are among the most promising approaches to fighting cancer. However, a substantial percentage of patients experience off-target adverse effects in the form of mild to severe inflammation in different organs, commonly called immune-related adverse events (irAEs). irAEs can lead to treatment discontinuation, or can be life-threatening in extreme cases. The causes of irAEs are largely unknown and there are no reliable predictive biomarkers. The Montreal Immune-Related Adverse Events (MIRAE) study collects clinical information and biospecimens (blood, tissue, stool) from cancer patients treated with ICI to facilitate research on the identification of predictive biomarkers of irAEs, their causes, and the design of effective management strategies.",[193,194,195,196],"Cancer","Immune System Disorder","Inflammatory Reaction","Autoimmune Diseases",[198,199,200,201,202,203,204,205,206,207,208,209],"irAEs","ICI (ICB)","CTLA-4","PD-1","PDL-1","Pembrolizumab","Nivolumab","Ipilimumab","Cemiplimab","Atezolizumab","Avelumab","Durvalumab",{"date":211,"type":47},"2026-02-03",{"date":213,"type":47},"2020-01-21",{"date":51,"type":22},{"name":53,"class":54},{"id":217,"slug":218,"hasResults":11,"nctId":219,"briefTitle":220,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":223,"targetDuration":4,"studyType":23,"phases":224,"briefSummary":226,"conditions":227,"keywords":229,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":238,"leadSponsor":240,"locationsCount":83},"100621523","phase-4-effect-of-aprepitant-on-post-operative-nausea-and-vomiting-in-otologic-surgery-100621523","NCT07371728","Effect of Aprepitant on Post-operative Nausea and Vomiting in Otologic Surgery","Effect of Aprepitant on Post-operative Nausea and Vomiting in Otologic Surgery: A Pilot Randomized-Controlled Trial","Inclusion Criteria:\n\n* Adult patients undergoing middle ear surgery including tympanoplasty with or without ossicular chain reconstruction, tympanomastoidectomy or stapedectomy\n* Patient using a hormonal contraceptive will be included, but warned aprepitant may reduce the efficacy of hormonal contraception thus an alternative or backup contraceptive methods should be used for one month after surgery\n\nExclusion Criteria:\n\n* Children (\\\u003C18 years old)\n* Patients unable to complete the post-procedure questionnaire (either due to time constraints, neurocognitive impairment, etc.)\n* Patients taking concomitant medications that are substrates, inhibitors or inducers of CYP3A4 or CYP2CP that are at risk of having a clinically significant effect\n* Patients with a history of hypersensitivity reaction to any of the medications used in the study\n* Patients who are pregnant or breastfeeding\n* Patients unable to receive general anesthesia (i.e. procedures performed under local anesthesia with or without sedation)\n* Patients with severe hepatic insufficiency (Child-Pugh class C)\n* Patients on total intravenous anesthesia (TIVA)",{"count":165,"type":22},[225],"PHASE4","This project is being carried out to study the use of a medication to reduce nausea and vomiting after ear surgery.",[228],"Otologic Disease",[230,231,232,233],"aprepitant","nausea","vomiting","otologic surgery","2026-01-18",{"date":236,"type":47},"2026-01-28",{"date":151,"type":22},{"date":239,"type":22},"2028-06-01",{"name":53,"class":54},{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":249,"minAge":18,"maxAge":250,"enrollmentInfo":251,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":253,"conditions":254,"keywords":256,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":277},"100584365","long-term-safety-of-nipple-sparing-mastectomy-in-women-with-high-penetrance-breast-cancer-susceptibility-genes-in-breast-cancer-100584365","NCT06888388","Long-term Safety of Nipple Sparing Mastectomy in Women With High Penetrance Breast Cancer Susceptibility Genes in Breast Cancer","Long-term Oncologic Safety of Nipple Sparing Mastectomy in Women With High Penetrance Germline Pathogenic Variants in Breast Cancer Susceptibility Genes","NSM","Inclusion Criteria:\n\n* Assigned female sex at birth\n* Age 18 years or older\n* Confirmed GPV in BRCA1, BRCA2, PALB2, TP53, CDH1 or PTEN identified on pre-symptomatic genetic testing\n\nExclusion Criteria:\n\n* History of breast cancer prior to genetic testing\n* History of ovarian cancer prior to genetic testing\n* History of bilateral mastectomy performed prior to genetic testing\n* Presence of a variant of uncertain significance (VUS) in the absence of another GPV in BRCA1, BRCA2, PALB2, TP53, CDH1 or PTEN.","FEMALE","90 Years",{"count":252,"type":22},4700,"Patients with a germline pathogenic variant (GPV) in high-penetrance breast cancer susceptibility genes who are considering risk reducing mastectomy (RRM) often strongly desire to keep their nipple areola complex but inquire as to whether it is safe to do so. Relative to traditional or skin sparing mastectomy (SSM) techniques, nipple sparing mastectomy (NSM) is associated with improved psychosocial and sexual well-being and is significantly better for body image and reducing feelings of disfigurement.\n\nDespite this, guidelines have yet to endorse the use of NSM over other RRM techniques, stating that more data and longer follow-up are needed to confirm it as a safe and effective strategy in GPV carriers. As NSM was not routinely adopted in high-risk patient populations undergoing RRM before 2010, there has been little data to inform the long-term oncologic safety of NSM. Well-designed studies have reported low to negligible rates of subsequent breast cancer in BRCA1\u002F2 carriers following NSM, but have been limited by short median follow-up of less than 3 years. The current study is designed to confirm, with longer follow-up, prior findings on the oncologic safety of NSM in unaffected BRCA1\u002F2 carriers. The investigators will also expand data to other high-penetrance GPV carriers, including PALB2, CDH1, PTEN, and TP53, for whom there is little-to-no data on outcomes following RRM.",[255],"Breast Cancer Surgery",[257,258,259,260,261,262,263,264,265,266,267,268],"breast cancer surgery","nipple sparing mastectomy","oncologic safety","Cancer prevention","Breast Cancer Prevention","BRCA","germline pathogenic variant","GPV","Li Fraumeni","Hereditary lobular breast cancer","Cowden syndrome","PALB2","2025-12-01",{"date":271,"type":47},"2025-12-08",{"date":273,"type":47},"2025-02-01",{"date":275,"type":22},"2028-02-01",{"name":53,"class":54},12,{"id":279,"slug":280,"hasResults":11,"nctId":281,"briefTitle":282,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":23,"phases":287,"briefSummary":288,"conditions":289,"keywords":295,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":302,"lastUpdatePostDateStruct":303,"startDateStruct":305,"completionDateStruct":307,"leadSponsor":309,"locationsCount":4},"100612544","phase-2-capecitabine-prior-to-tumor-resection-in-ent-oncology-capture-100612544","NCT07254962","CApecitabine Prior to TUmor Resection in Ent Oncology (CAPTURE)","CAPTURE","Inclusion Criteria:\n\n* • Previously untreated, histologically confirmed non-HPV related HNSCC and radiologically or histologically confirmed stage I or IVA (AJCC 8th edition).\n\n  * No evidence of distant metastatic disease.\n  * Able to undergo protocol therapy, including necessary imaging and surgery.\n  * If female: may participate if not actively pregnancy nor breastfeeding.\n  * If male: must agree to refrain from donating sperm and must either be abstinent or agree to use contraception.\n  * Performance status (ECOG) of 0, 1 or 2.\n\nExclusion Criteria:\n\n* History of immunodeficiency, HBV, HCV, HIV. No HBV, HCV or HIV testing is required unless mandated by local health authority.\n* Active infection requiring systemic therapy.\n* Previous allogenic tissue\u002Fsolid organ transplant.\n* Known severe hypersensitivity (≥ Grade 3) to capecitabine, its active substance and\u002For any of its excipients.\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.\n* Known DYPD mutation.\n* Known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial.\n* Received prior systemic anticancer therapy including investigational agents for the current malignancy prior to allocation.\n* Currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment.\n* Known additional malignancy that is progressing or requires active treatment within the past (5 years), excluding basal cell carcinoma or cutaneous squamous cell carcinoma.",{"count":286,"type":22},75,[25],"head and neck squamous cell carcinoma (HNSCC) is a type of cancer that affects areas such as the mouth, throat, and voice box. Despite medical progress, little has changed in the care for patients with HPV-negative cancer. The standard care involves surgery followed by radiation or chemotherapy if needed. However, delays in starting treatment - especially beyond six weeks - are linked to worse outcomes. Many patients also experience cancer returning within two years, often making it harder to treat. This study aims to improve outcomes by giving patients a short course of capecitabine, a chemotherapy pill, before surgery. Capecitabine is easier to tolerate than traditional intravenous chemotherapy and has shown promising results in shrinking tumors. Researchers believe that starting this oral treatment early could reduce delays, shrink tumors, make surgery less complex, and improve survival. The clinical trial will randomly assign patients with newly diagnosed stage III or IVa HPV-negative head and neck cancer to receive either standard care or capecitabine before surgery. Surgery will be performed within six weeks of diagnosis, followed by additional therapy as needed. The study will measure how well the tumor responds under the microscope after surgery, how much it shrinks on scans, the safety of the treatment, and cancer-free survival at two years. It will also explore biological markers linked to treatment response.\n\nIf successful, this approach could offer a simpler, faster, and more effective way to treat head and neck cancer, leading to earlier treatment, less invasive surgery, and improved patient outcomes. The study plans to include about 62 patients to evaluate the benefits of this new treatment strategy",[290,291,292,293,294],"Head Neck Cancer","Mouth Cancer","Throat Cancer","Larynx Cancer","Skin Cancer Face",[296,297,298,299,300,301],"window of opportunity","surgery","neoadjuvant","capecitabine","Head and neck cancer","HPV-negative","2025-11-19",{"date":304,"type":47},"2025-11-28",{"date":306,"type":22},"2026-01-01",{"date":308,"type":22},"2031-01-01",{"name":53,"class":54},{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":163,"minAge":18,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":23,"phases":320,"briefSummary":321,"conditions":322,"keywords":324,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":4},"100603751","pilot-study-of-a-new-nerve-grafting-method-during-bladder-cancer-surgery-to-help-preserve-erections-100603751","NCT07140588","Pilot Study of a New Nerve Grafting Method During Bladder Cancer Surgery to Help Preserve Erections.","Pilot Study of Intraoperative Somatic-Autonomic Nerve Grafting Technique to Preserve Erectile Function in Patients With Bladder Cancer Undergoing Radical Cystectomy","NR-RC","Inclusion Criteria:\n\n* Patients undergoing standard of care radical cystectomy for bladder cancer\n* Patients must have preoperative erectile function with a baseline IIEF score of ≥17\n\nExclusion Criteria:\n\n* Patients with previous pelvic surgery\n* Patients with previous pelvic radiotherapy\n* Patients aged \\\u003C 18 years at diagnosis\n* Legally incapable patients\n* Patients who are unable to complete questionnaires and have no companion to help complete them\n* Patients undergoing a concomitant cancer surgery\n* Patients with pre-existing neurologic disease",{"count":319,"type":22},10,[94],"This pilot study will evaluate the safety and 1-year erectile function recovery in 10 patients undergoing a novel Nerve Restoring Radical Cystectomy (NR-RC), which includes a genitofemoral nerve graft. Erectile function will be assessed using IIEF-5, SF-MPQ, and CEEF questionnaires at baseline and at multiple post-operative intervals (4 weeks, 3, 6, 12, and 18 months). Safety will be monitored through peri- and post-operative complications, and additional demographic and clinical data will be collected for analysis.",[323,170],"Bladder Cancer Requiring Cystectomy",[325,326,327,328,329,330,331,332,333],"Bladder cancer","Nerve grafting","The genitofemoral nerve","radical cystectomy","radical prostatectomy","Erectile function","International Index of Erectile Function-5","Short Form McGill Pain Questionnaire","Clinical Evolution of Erectile Function","2025-08-18",{"date":336,"type":47},"2025-08-24",{"date":338,"type":22},"2025-09",{"date":340,"type":22},"2029-02",{"name":53,"class":54},{"id":343,"slug":344,"hasResults":11,"nctId":345,"briefTitle":346,"officialTitle":347,"acronym":348,"eligibilityCriteria":349,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":350,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":351,"conditions":352,"keywords":4,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":354,"lastUpdatePostDateStruct":355,"startDateStruct":357,"completionDateStruct":359,"leadSponsor":361,"locationsCount":4},"100593241","penthrox-in-otolaryngology-100593241","NCT07003880","Penthrox in Otolaryngology","Inhaled Methoxyflurane for In-Office Procedures in Otolaryngology","PenthroxOTL","Inclusion Criteria:\n\n* All adult patients undergoing any of the following procedures with inhaled methoxyflurane as an adjunct to topical or local anesthesia:\n\n  * Skin lesion excision or reconstruction\n  * Fine or core needle aspiration biopsy\n  * Mucosal biopsy\n  * Laryngeal injection or biopsy\n  * Myringotomy with or without tympanostomy tube insertion\n  * Inferior turbinate reduction\n  * Septal button insertion\n\nExclusion Criteria:\n\n* Patient unable to complete the post-procedure questionnaire (either due to time constraints, neurocognitive impairment, etc.)\n* Presence of any contraindications to inhaled methoxyfluorane per product monograph:\n\n  * Patients less than 18 years of age\n  * Pregnancy, intended pregnancy, or current breast-feeding\n  * Inadequate patient understanding or lack of cooperation\n  * Decreased level of consciousness or head injury\n  * History of clinically significant renal impairment, e.g., reduced renal output\n  * History of liver dysfunction following previous exposure to halogenated anesthetics\n  * Current use of tetracycline antibiotics\n  * Personal or genetic history of malignant hyperthermia\n  * Muscular dystrophy",{"count":92,"type":22},"Our objective is to explore the use of methoxyflurane anesthesia as an adjunct analgesic to local anesthesia during in-office otolaryngology procedures in a prospective pilot study. The main outcome of this study will be patient satisfaction with the medication and analgesia. Secondary outcomes will include level of sedation and analgesia, patient-reported post-procedural pain levels, and any reported adverse events.",[353],"All Adult Patients Undergoing an Otolaryngology Procedure With Inhaled Methoxyflurane as an Adjunct to Topical or Local Anesthesia","2025-05-26",{"date":356,"type":47},"2025-06-04",{"date":358,"type":22},"2025-06-01",{"date":360,"type":22},"2027-06-01",{"name":53,"class":54},{"id":363,"slug":364,"hasResults":11,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":368,"eligibilityCriteria":369,"healthyVolunteers":11,"sex":17,"minAge":370,"maxAge":4,"enrollmentInfo":371,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":372,"conditions":373,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":375,"lastUpdatePostDateStruct":376,"startDateStruct":378,"completionDateStruct":380,"leadSponsor":382,"locationsCount":83},"100465013","hypotension-prediction-index-in-postoperative-surgical-patients-100465013","NCT05335174","Hypotension Prediction Index in Postoperative Surgical Patients","Hypotension Prediction Index in Postoperative Surgical Patients in the Post-anesthetic Recovery Room - a Feasibility Study","HPI-PACU","Inclusion Criteria:\n\n1. Patient ≥45 years old\n2. Will undergo open colorectal, hepatobiliary, or vascular surgery;\n3. Is expected to have an arterial cannula inserted intraoperatively;\n4. Has an anticipated stay in PACU for at least 2 hours;\n5. Able to provide written informed consent\n\nExclusion Criteria:\n\n1. Planned admission to ICU;\n2. Refusal to participate;\n3. Previously enrolled in the study","45 Years",{"count":115,"type":22},"PACU-HPI study evaluates the use of a hemodynamic monitor in the post-anesthetic recovery room on patients undergoing colorectal, hepatobiliary, and vascular surgery, to determine the feasibility of recruiting this surgical population.",[374],"Surgery","2025-05-16",{"date":377,"type":47},"2025-05-18",{"date":379,"type":47},"2022-04-01",{"date":381,"type":22},"2027-03-01",{"name":53,"class":54},{"id":384,"slug":385,"hasResults":11,"nctId":386,"briefTitle":387,"officialTitle":388,"acronym":389,"eligibilityCriteria":390,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":391,"targetDuration":4,"studyType":23,"phases":393,"briefSummary":394,"conditions":395,"keywords":398,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":413},"100459054","phase-3-aggressive-smoking-cessation-trial-asap-100459054","NCT05257629","Aggressive Smoking Cessation Trial (ASAP)","Aggressive Smoking Cessation Therapy Among People at Elevated Cardiovascular Risk (ASAP) Trial","ASAP","Inclusion Criteria:\n\n1. Patients currently hospitalized or being discharged from hospital who have suffered an ACS, defined as follows:\n\n   i. MI, defined by positive troponin T, troponin I, or CK-MB levels (as defined by institution-specific cut-offs) and ≥ 1 of the following:\n   1. Ischemic symptoms for ≥ 20 min;\n   2. Electrocardiogram (ECG) changes indicative of ischemia (ST-segment elevation or depression);\n   3. Development of pathological Q waves on the ECG\n\n   ii. Unstable angina with significant coronary artery disease, defined by all of the following:\n   1. Ischemic symptoms for ≥ 20 min;\n   2. ECG changes indicative of ischemia (ST-segment changes);\n   3. At least one lesion ≥ 50% on angiogram performed during the current hospitalization.\n\n   \\[Note: patients who undergo cardiac catheterization or percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery will be eligible provided they are able to start varenicline in-hospital and nicotine e-cigarette at discharge.\\]\n\n   OR\n\n   Outpatients with the following diagnoses\u002Fconditions:\n\n   i. Cardiovascular:\n   1. Coronary artery disease documented with angiography or coronary CT;\n   2. Previous ACS, MI, stable or UA;\n   3. Previous coronary revascularization (e.g. PCI or CABG). ii. Renovascular:\n\n   a. Chronic kidney disease. iii. Cerebrovascular:\n\n   a. Previous cerebral infarction or transient cerebral ischemic attack. iv. Peripheral vascular:\n   1. Abdominal aortic aneurysm \\> 3.0 cm or previous aortic aneurysm surgery;\n   2. Ankle-brachial pressure index of \\\u003C 0.9 or intermittent claudication;\n   3. Documented carotid artery disease;\n   4. Lower-limb amputation;\n   5. Previous lower-limb bypass surgery or angioplasty.\n\n   v. ≥1 risk factors:\n   1. BMI ≥ 27 kg\u002Fm2;\n   2. Dyslipidemia;\n   3. Family history (first degree relative: parents or siblings only) of coronary heart disease or stroke before the age of 60 years;\n   4. Hypertension;\n   5. Males aged ≥ 55 years\u002Ffemales aged ≥ 60 years;\n   6. Diabetes mellitus. vi. Heart-related conditions:\n\n   \u003C!-- -->\n\n   1. Atrial fibrillation or flutter;\n   2. Cardiomyopathy;\n   3. Heart failure;\n   4. Left ventricular hypertrophy (evidenced by echocardiography or ECG);\n   5. Valvular disease (evidenced by echocardiography).\n2. Smoked on average ≥ conventional cigarettes\u002Fday for the past year;\n3. Age ≥18 years;\n4. Motivated to quit smoking according to the Motivation To Stop Scale (MTSS) (≥ level 5);\n5. Able to understand and provide informed consent in English or French;\n6. If randomized to the combination arm (varenicline and e-cigarette plus counseling), willing and able to purchase e-cigarettes with the following properties: rechargeable, closed system that uses sealed cartridges or pods, tobacco or no flavor only, and nicotine strength of 20 mg\u002Fml (2%) or less;\n7. Likely to be available for 52 weeks of follow-up.\n\nExclusion Criteria:\n\n1. Pregnant or lactating females;\n2. Use of any of the following in the 30 days prior to eligibility assessment:\n\n   i. Varenicline or bupropion for smoking cessation; ii. Nicotine or non-nicotine e-cigarettes; iii. Other anti-craving medication (e.g., naltrexone, acamprosate) with the potential to alter substance-seeking behaviors;\n3. Use of nicotine replacement therapy (NRT) in the 7 days prior to eligibility assessment \\[Note: If participant is prescribed non-study NRT while hospitalized, they can continue using the non-study NRT until being discharged, even while taking the investigational products. Upon discharge, use of the non-study NRT should be stopped.\\];\n4. Use of varenicline or e-cigarettes (nicotine or non-nicotine) for ≥14 days consecutively in the past year;\n5. Previous serious adverse reaction to varenicline and\u002For e-cigarettes (nicotine or non-nicotine);\n6. NYHA or Killip Class III or IV at the time of randomization;\n7. Any unstable psychiatric disorder (as per enrolling physician);\n8. Renal impairment with creatinine levels ≥2 times upper limit of normal or eGFR ≤15;\n9. Use of any illegal drugs in the past year;\n10. Planned use of cannabis (smoked) or other tobacco products (smoked or other) during the study period. \\[Note: use of cannabis which is not smoked is permitted (e.g., edibles, ingested or vaped oils). However, methods which involve combustion could invalidate biochemical validation via exhaled carbon monoxide.\\]",{"count":392,"type":22},798,[26],"The ASAP Trial is a 5-year, multi-centre, randomized controlled trial that will assess the efficacy, safety, and tolerability of aggressive smoking cessation therapy among people at elevated cardiovascular risk. It will recruit 798 adult patients smoking on average at least 10 conventional (tobacco) cigarettes per day who are motivated to quit smoking and have either been diagnosed with ACS requiring hospitalization or are outpatients at elevated cardiovascular risk. Patients will be randomized (1:1) to one of two treatment arms: (1) combination therapy of varenicline and nicotine e-cigarettes plus counseling or (2) varenicline plus counseling for 12 weeks, with 52-week follow-up.",[396,397],"Acute Coronary Syndrome","Cardiovascular Diseases",[399,400,401,402,403,404],"acute coronary syndrome","smoking cessation","randomized controlled trial","varenicline","e-cigarettes","cardiovascular disease","2025-04-24",{"date":407,"type":47},"2025-04-29",{"date":409,"type":47},"2023-02-02",{"date":411,"type":22},"2027-03-07",{"name":53,"class":54},13,{"id":415,"slug":416,"hasResults":11,"nctId":417,"briefTitle":418,"officialTitle":419,"acronym":420,"eligibilityCriteria":421,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":422,"targetDuration":424,"studyType":68,"phases":4,"briefSummary":425,"conditions":426,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":431,"completionDateStruct":433,"leadSponsor":435,"locationsCount":83},"100479985","telo-genomics-technology-to-detect--profile-multiple-myeloma-mrd-100479985","NCT05530096","Telo Genomics Technology to Detect & Profile Multiple Myeloma MRD","Detect and Profile Multiple Myeloma Measurable Residual Disease (MRD )Prognostics for Monitoring Post-transplant Multiple Myeloma (MM) Patients Receiving Maintenance Therapy.","TELO - DMRD","Inclusion Criteria:\n\n* Confirmed MM diagnosis\n* Transplant eligible patients in a first remission\n* Known MRD level detected by ClonoSeq (other IMWG recognized methodologies can be also employed)\n* Availability of deidentified patient's demographic and clinical follow up data\n* Receiving standard of care treatment\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Failure to meet inclusion criteria",{"count":423,"type":22},70,"24 Months","The purpose :\n\nDetect and profile Multiple myeloma Measurable Residual Disease(MRD) prognostics for monitoring post-transplant Multiple Myeloma (MM) Patients receiving maintenance therapy.",[427],"Multiple Myeloma","2025-03-30",{"date":430,"type":47},"2025-04-03",{"date":432,"type":47},"2024-05-01",{"date":434,"type":22},"2028-09",{"name":53,"class":54},{"id":437,"slug":438,"hasResults":11,"nctId":439,"briefTitle":440,"officialTitle":440,"acronym":4,"eligibilityCriteria":441,"healthyVolunteers":11,"sex":163,"minAge":18,"maxAge":4,"enrollmentInfo":442,"targetDuration":4,"studyType":68,"phases":4,"briefSummary":444,"conditions":445,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":446,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":454},"100253108","the-predictive-value-of-coexisting-tmprss2-erg-gene-fusion-and-pten-deletion-in-prostate-cancer-patients-with-biochemical-failure-status-post-salvage-or-radical-radiation-therapy-100253108","NCT02573636","The Predictive Value of Coexisting TMPRSS2-ERG Gene Fusion and PTEN Deletion in Prostate Cancer Patients with Biochemical Failure Status Post Salvage or Radical Radiation Therapy","Inclusion Criteria:\n\n* T3a +\n* PSA \\> 20\n* Gleason 8 or higher\n* Karnofsky performance status ≥ 70.\n* Signed study-specific informed consent\n\nExclusion Criteria:\n\n\\-",{"count":443,"type":22},208,"The objective of the study is to evaluate the predictive value of TMPRSS2-ERG gene fusion and PTEN in patients with high risk prostate cancer treated with first line LHRH agonist after biochemical failure.",[169],"2024-12-02",{"date":448,"type":47},"2024-12-04",{"date":450,"type":47},"2016-03",{"date":452,"type":22},"2027-03",{"name":53,"class":54},9,{"id":456,"slug":457,"hasResults":11,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":11,"sex":163,"minAge":18,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":23,"phases":464,"briefSummary":465,"conditions":466,"keywords":4,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":474,"locationsCount":475},"100556178","nerve-grafting-technique-to-preserve-erectile-function-in-patients-undergoing-robotic-assisted-radical-prostatectomy-100556178","NCT06521710","Nerve Grafting Technique to Preserve Erectile Function in Patients Undergoing Robotic Assisted Radical Prostatectomy","Phase I Clinical Trial: Pilot Study of Intraoperative Somatic-Autonomic Nerve Grafting Technique to Preserve Erectile Function in Patients With High Grade Prostate Cancer Undergoing Robotic Assisted Radical Prostatectomy","NR-RALP","Inclusion Criteria:\n\n1. Patients undergoing standard of care robotic radical prostatectomy for high-risk localized prostate cancer as defined by any of:\n\n   1. Gleason grade ≥8\n   2. PSA ≥20\n   3. \\>pT2 on preoperative MRI imaging\n2. Patients must have preoperative erectile function with a baseline IIEF score of ≥17\n\nExclusion Criteria:\n\n1. Patients with previous pelvic surgery\n2. Patients with previous pelvic radiotherapy\n3. Patient with previous focal therapy for prostate cancer\n4. Patients aged \\\u003C 18 years at diagnosis\n5. Legally incapable patients\n6. Patients who are unable to complete questionnaires and have no companion to help complete them\n7. Patients undergoing a concomitant cancer surgery\n8. Patients with pre-existing neurologic disease",{"count":319,"type":22},[94],"The investigator proposing a single arm prospective pilot trial evaluating the safety and the 1-year erectile recovery outcomes of patients undergoing Nerve Restoring (NR) Robotically assisted laparoscopic radical prostatectomy (RALP). During this study a total of 10 patients who are undergoing robotic prostatectomy will have their surgery performed utilizing a novel technique, NR-RALP, which incorporates a genitofemoral (GFN) nerve graft designed to try to improve the erectile function and recovery of men undergoing standard of care robotic prostatectomy while minimizing additional morbidity of the procedure",[169,467],"Erectile Dysfunction","2024-09-14",{"date":470,"type":47},"2024-09-19",{"date":472,"type":22},"2024-09",{"date":103,"type":22},{"name":53,"class":54},2,{"id":477,"slug":478,"hasResults":11,"nctId":479,"briefTitle":480,"officialTitle":481,"acronym":4,"eligibilityCriteria":482,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":483,"targetDuration":4,"studyType":23,"phases":484,"briefSummary":485,"conditions":486,"keywords":488,"overallStatus":146,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":83},"100556854","phase-2-pretreatment-botulinum-toxin-in-head-and-neck-cancer-surgery-100556854","NCT06530524","Pretreatment Botulinum Toxin in Head and Neck Cancer Surgery","Pretherapy Botulinum Toxin to Reduce Radiation-related Xerostomia in Head and Neck Cancer","Inclusion Criteria:\n\n* Newly diagnosis AJCC 8th edition Stage III\u002FIVa mucosal head and neck squamous cell carcinoma requiring definitive radiotherapy (with or without chemotherapy).\n\nExclusion Criteria:\n\n* Previous radiation to the head and neck\n* Previous treatment for head and neck cancer\n* Personal history of xerostomia\n* Hypersensitivity to onabotulinumtoxinA\n* Previous major salivary gland surgery\n* Previous exposure to radioactive iodine therapy",{"count":92,"type":22},[25],"Head and neck cancer care, including tumors of the mouth, nose, throat and voice box, often requires radiation for cure to be achieved. Despite advances in radiation, 40% to 60% of patients experience a significant dry mouth (xerostomia) following radiotherapy. Several factors are associated with severe xerostomia including older age, advanced stage disease and tumor location. Currently, no pragmatic treatment strategy exists to reduce the risk of radiation-related xerostomia in patients with head and neck cancer. The investigators propose the use of a botulinum neurotoxin injected into the at-risk salivary glands before radiation as a strategy to preserve salivary gland function during radiation treatments and reduce xerostomia.",[290,487],"Xerostomia Following Radiotherapy",[489,490,491,492],"Head and Neck Cancer","Radiation induce xerostoma","botulinum toxin","salivary glands","2024-07-26",{"date":495,"type":47},"2024-07-31",{"date":497,"type":22},"2024-10-01",{"date":499,"type":22},"2027-12-01",{"name":53,"class":54},""]