[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"head-amp-neck-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:head-amp-neck-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,71,102,137],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100609696","phase-2-novel-treatment-of-radiation-associated-dysphagia-with-statins-100609696",false,"NCT07217938","Novel Treatment of Radiation Associated Dysphagia With Statins","TRADstat: Novel Treatment of Radiation Associated Dysphagia With Statins","TRADstat","Inclusion Criteria:\n\n1. Patient has provided written informed consent using the TRADstat PICF\n2. Patients aged 18 years or older at screening\n3. Received curative intent (chemo)radiotherapy to the nasopharynx, oropharynx, hypopharynx or larynx at least 2 years prior to screening\n4. Moderate-severe RAD using validated cut-offs (PAS score \\> 3 and\u002For DIGEST grading ≥ 2), identified on a VFSS conducted within the last 12 months\n5. Adequate kidney function defined as estimated glomerular filtration rate (eGFR) ≥ 40 ml\u002Fmin\n6. Adequate hepatic function defined as:\n\n   * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels less than 2 times the upper normal limit (ULN)\n   * Bilirubin level at least 1.5 times lower than the ULN\n7. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2 (Appendix 1)\n\nExclusion Criteria:\n\n1. Known hypersensitivity to pravastatin and\u002For any excipients\n2. Diagnosis of myasthenia (muscle weakness)\n3. History of head or neck surgery, other than excisional biopsy or post treatment neck dissection\n4. Known active malignancy\n5. Currently taking statin medication\n6. Currently taking prohibited medicines (long-term steroids or drugs listed under Section 8.4)\n7. History of severe heart failure; a history of muscle toxicity during previous treatments with fibrates or statins; a history of hereditary muscle diseases\n8. Known medical condition(s) that may impact swallowing function (e.g., stroke, neurological conditions, tracheostomy)\n9. Pregnant or breastfeeding","ALL","18 Years",{"count":20,"type":21},48,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The aim of this trial is to examine the feasibility, acceptability, and potential efficacy of a 12-month course of pravastatin as an antifibrotic agent for managing dysphagia (swallowing problems) in patients previously treated with radiotherapy for head and neck cancer (HNC). The purpose is to assess whether pravastatin, a medication approved in Australia for cholesterol management, can improve swallowing in people with long-term radiation-associated dysphagia following HNC treatment.\n\nThe trial will recruit 48 patients, with an anticipated accrual period of approximately 6 months. Eligible patients will be identified from the Principal Investigator's current study, ERADICATE, or through referral by a radiation oncologist or speech pathologist diagnosing radiation-induced dysphagia.\n\nParticipants will receive 40 mg of pravastatin daily for up to 12 months, with swallowing assessments conducted before, during, and after treatment.",[27,28],"Radiation-associated Dysphagia","Head &Amp; Neck Cancer",[30,31,32,33],"Radiation-associated dysphagia","Dysphagia","Head & neck cancer","Pravastatin","RECRUITING","2026-03-01",{"date":37,"type":38},"2026-03-03","ACTUAL",{"date":40,"type":38},"2025-12-05",{"date":42,"type":21},"2028-10-01",{"name":44,"class":45},"Peter MacCallum Cancer Centre, Australia","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":53,"minAge":4,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":46},"100586237","phase-2-reversing-external-beam-radiotherapy-associated-fibrosis-syndrome-an-interventional-bayesian-adaptive-randomized-controlled-orphan-drug-platform-trial-for-orodental-sequelae-reverse-fibrose-100586237","NCT06912763","Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)","Eligibility Criteria Eligibility criteria (observational registry or randomization)\n\n1. Prior history of head and neck cancer with no active disease.\n2. Treated previously with radiotherapy with prescribed dose (greater or equal to 30Gy) to unilateral or bilateral neck(s)\n3. Detectable CTC-AE G2+ lymphedema\u002Ffibrosis at \\>6 months post-radiotherapy.\n4. No active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism, nor history of ulcers.\n5. No history of myopathy\u002Frhabdomyolysis.\n6. Creatinine clearance \\\u003C30mL\u002Fmin.\n7. No history of acute myocardial infarction or severe coronary disease.\n8. Non-pregnant\u002Fpost-menopausal, or male.\n9. No history of diabetes mellitus\n10. Allergy\u002Fhypersensitivity to HMG Co-A reductase inhibitor and\u002For xanthine derivatives, e.g., caffeine, theophylline, theobromine\n11. No contraindications for magnetic resonance imaging a Subject to the discretion of the treating physician and Principal Investigator (PI), as the MRI may be optional\n\nExclusion Criteria\n\n1. Active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism.\n2. History of myopathy\u002Frhabdomyolysis.\n3. History of acute myocardial infarction or severe coronary disease.\n4. Pregnant\u002Fpost-menopausal, or male.\n5. History of diabetes mellitus.\n6. Allergy\u002Fhypersensitivity to Hydroxymethylglutaryl-coenzyme A (HMG Co-A) reductase inhibitor and\u002For xanthine derivatives, e.g., caffeine, theophylline, theobromine.\n7. Contraindications for MRI Subject to the discretion of the treating physician and Principal Investigator (PI), as the MRI may be optional\n8. Participants who are receiving any other investigational agents.\n9. History of allergic reactions attributed to compounds of similar chemical or biologic composition to statins, hemorheologic agents or other agents used in study\n10. Participants with psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.","FEMALE",{"count":55,"type":21},250,[24],"To find out if adding medication can help treat or prevent lymphedema and\u002For fibrosis related to radiation therapy, in survivors of head and neck cancer. Researchers will compare these drugs to find the most effective therapy for preventing or limiting these side effects.",[59,60,28,61],"Fibrosis Syndrome","Lymphedema","Fibrosis","2026-01-23",{"date":64,"type":38},"2026-01-26",{"date":66,"type":38},"2025-08-08",{"date":68,"type":21},"2033-03-01",{"name":70,"class":45},"M.D. Anderson Cancer Center",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":88,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"100607708","phase-2-clinical-trial-evaluating-the-activity-of-zanidatamab-for-the-treatment-of-patients-with-solid-tumors-with-an-alteration-of-the-her2-gene-100607708","NCT07192068","Clinical Trial Evaluating the Activity of Zanidatamab for the Treatment of Patients With Solid Tumors With an Alteration of the HER2 Gene.","Widening Treatment Options Among Adult Patients With HER2-overexpressing or Mutant Solid Cancers.","AcSé HER2","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed endometrial, colorectal, head \\& neck, non-small cell lung cancer (NSCLC), or sarcoma\n2. Patient with progressive, unresectable and\u002For advanced or metastatic disease harboring a locally performed, centrally reviewed HER2-overexpressing (IHC 3+ exclusively) for endometrial, colorectal, head \\& neck cancers, or sarcoma or a HER2 activating mutation for NSCLC, determined on tissue (see Section 7.1.2 of the protocol)\n3. Age ≥ 18 years at inclusion\n4. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2\n5. Patient who progressed at least after 1 line of therapy, for whom there is no other standard therapeutic option available\n6. Patient with a HER2 alteration covered by a standard marketed indication for any HER2 targeting therapy should be included after standard anti-HER2 strategy has been exhausted.\n7. Estimated life expectancy \\>3 months\n8. Measurable disease according to RECIST1.1, whatever the disease location. Tumor lesions located in a previously irradiated area, or in an area subjected to other loco-regional therapy, are considered measurable if progression has been clearly demonstrated in the lesion\n9. Adequate bone marrow function: absolute neutrophil count (ANC) ≥1.5 × 10⁹\u002FL, platelet count ≥75 × 10⁹\u002FL, and haemoglobin ≥9 g\u002FdL. Transfusion is allowed with a 2-week washout period before treatment initiation\n10. Adequate liver function: total bilirubin level ≤1.5 × the upper limit of normal (ULN) range (total bilirubin ≤3.0 ULN when the patient has documented Gilbert syndrome or liver metastasis), and aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels ≤2.5 × ULN (AST and ALT ≤5 ULN when documented tumor liver involvement)\n11. Adequate cardiac function: left ventricular ejection fraction (LVEF) ≥ 50% at baseline as determined by either echocardiogram (ECHO) or multigated acquisition (MUGA) scan within 14 days before inclusion\n12. Normal prothrombin time (PT) \\>70% and partial thromboplastin time (PTT), except for patient who uses anticoagulants\n13. Adequate renal function: estimated serum creatinine clearance ≥ 30 mL\u002Fmin according to the Cockcroft-Gault formula\n14. Man, and woman of childbearing potential must agree to use highly effective contraception for the duration of trial participation and as required after completing study treatment (refer to Table 6 in the protocol). Man must also agree to not donate sperm and women must agree to not donate oocytes during the specified period\n15. Woman of childbearing potential must have a negative serum pregnancy test performed within 3 days before the date of treatment initiation\n16. Availability of a suitable archived FFPE sample of primary or metastatic tumor tissue (archived FFPE is \\\u003C2 years old (desirable), maximum 5 years (accepted), buffered formalin fixed only. Fine-needle aspiration (cytology samples) and biopsies from sites of bone metastases are not acceptable) or patient accepts an optional biopsy under study\n17. Willing and able to comply with the protocol for the duration of the study including scheduled visits, treatment plan, laboratory tests, specimen sampling for research, and other study procedures\n18. Affiliated to a social security system\n19. Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in signing the patient's consent.\n\nExclusion Criteria:\n\n1. Patient, in the judgment of the investigator, who should be included in another recruiting study assessing an anti-HER2 therapy (including zanidatamab)\n2. Patient who received prior treatment with HER2-directed therapy unless marketed for the study cohort indication.\n3. Other primary malignancies within 3 years with the exception of adequately treated cone-biopsied in situ carcinoma of the cervix uteri and basal or squamous cell carcinoma of the skin. Cancer survivor, who has undergone potentially curative therapy for a prior malignancy, has no evidence of that disease for 4 years or more and is deemed at negligible risk for recurrence, is eligible for the trial\n4. Any autoimmune, connective tissue or inflammatory disorder with pulmonary involvement not related to lung metastases (e.g. rheumatoid arthritis, Sjögren's syndrome, sarcoidosis)\n5. Prior pneumonectomy\n6. Patient with any condition or any evidence of severe or uncontrolled systemic diseases (e.g. active bleeding diatheses, active infection, or psychiatric illness) which in the investigator's opinion makes it undesirable for the patient to participate in the study or which would jeopardize compliance with the protocol. Screening for chronic conditions is not required for eligibility\n7. History of myocardial infarction or unstable angina within 6 months prior to enrolment, troponin levels consistent with myocardial infarction, or clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension, or any history of symptomatic congestive heart failure\n8. Evidence of spinal cord compression or brain metastases, defined as being clinically active and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Patient with clinically inactive or treated brain metastases who are asymptomatic (i.e. without neurologic signs or symptoms and do not require treatment with corticosteroids or anticonvulsants) may be included in the study. Patient must have a stable neurologic status and no evidence of radiographic progression for at least 2 weeks prior to first zanidatamab dosing\n9. Patient with evidence of any leptomeningeal disease. If leptomeningeal disease has been reported radiographically on baseline magnetic resonance imaging (MRI), but is not suspected clinically by the investigator, the subject must be free of neurological symptoms.\n10. Acute or chronic uncontrolled pancreatitis or Child-Pugh Class C liver disease\n11. Patient with unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to grade ≤1 or baseline, as defined by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Patient with chronic Grade 2 toxicities may be enrolled at the discretion of the investigator after consultation and approval by the coordinating investigator.\n12. Patient receiving chronic systemic corticosteroids dosed at \\>10 mg prednisone or equivalent anti-inflammatory activity or any form of immunosuppressive therapy within 2 weeks of first zanidatamab dosing unless otherwise approved by the coordinating investigator. Patient who requires use of bronchodilators, inhaled or topical or ocular steroids, or local steroid injections may be included in the study\n13. Treatment with anthracyclines within 90 days before first dose of zanidatamab and\u002For total lifetime load exceeding 360 mg\u002Fm2 doxorubicin or equivalent\n14. A history of life-threatening hypersensitivity to monoclonal antibodies or recombinant proteins\n15. Woman who is pregnant or breast-feeding\n16. Participation in another therapeutic trial within the 30 days prior to entering the study. Participation in an observational trial would be acceptable\n17. Patient unwilling or unable to comply with the medical follow-up required by the trial because of geographic, familial, social, or psychological reasons\n18. Individual deprived of liberty or placed under protective custody or guardianship.",{"count":80,"type":21},105,[24],"Alterations in the HER2 gene are involved in the development of cancer. These abnormalities are found at highly variable rates (from approximately 2% to 60%) in cancers of the lung, breast, stomach, bile ducts, salivary glands, colon, endometrium, uterus, bladder, bones, blood, etc. Zanidatamab is an anti-cancer drug that acts on cells with alterations in the HER2 gene. It is used in Europe to treat people with bile duct cancer.\n\nHowever, in various clinical trials, zanidatamab has shown promising activity in a few patients with different cancers that have a HER2 gene alteration. This treatment could therefore be effective in several types of cancer once this gene alteration is detected.\n\nThe primary objective is to evaluate the efficacy of zanidatamab in patients with cancer in one of the following locations: endometrium, colorectal, head and neck, sarcoma or lung cancer. Efficacy will be measured by the number of patients in whom a reduction in tumour size was observed.\n\nAll patients included in the study will receive zanidatamab by intravenous infusion every 3 weeks. Treatment will continue as long as there is a benefit (stabilisation or regression of the disease). During treatment, participants will visit the hospital regularly for medical consultations to:\n\n* assess and treat potential adverse effects of zanidatamab. A dose reduction may be applied to improve tolerance.\n* monitor disease progression using scans and\u002For MRI, performed every 6 weeks for the first 18 months of treatment and then every 12 weeks.\n\nAfter treatment is stopped (due to intolerance or disease progression), patients will be monitored according to hospital practices until the end of the trial, i.e. for 1 to 4 years, depending on when they were included in the clinical trial.",[84,85,28,86,87],"Non-Small Cell Lung Cancer","Sarcoma","Colorectal Carcinoma","Endometrial",[89,90,91],"zanidatamab","HER2 mutant","HER2-IHC3+","2025-12-18",{"date":94,"type":38},"2025-12-19",{"date":96,"type":38},"2025-10-30",{"date":98,"type":21},"2030-06-24",{"name":100,"class":45},"UNICANCER",4,{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":114,"conditions":115,"keywords":118,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":46},"100611613","rice-bran-supplementation-for-radiation-induced-oral-mucositis-in-head-and-neck-cancer-100611613","NCT07242859","Rice Bran Supplementation for Radiation-Induced Oral Mucositis in Head and Neck Cancer","Effects of Rice Bran on Radiation-Induced Oral Mucositis in Patients With Head\u002FNeck Cancer and Its Impact on the Quality of Life","RICE-MUC","Inclusion Criteria:\n\n* Male or female patients of age 18 years old tor more\n* Patients with squamous cell carcinomas without metastases of other non-head and non-neck tumors.\n* Patients undergoing radiotherapy with an ECOG performance status of 0, 1, or 2\n* Patients who will receive IMRT delivered as radical or adjuvant therapy with or without concurrent chemotherapy\n* Ready to provide written informed consent\n\nExclusion Criteria:\n\n* Receiving any other approved or investigational anti-cancer agent than those specified in this study.\n* Pregnant or breastfeeding female patients\n* Patients who have oral lesions unrelated to treatment or cancer,\n* Patients who are on drugs that could cause oral lesions or are using anticoagulants.",{"count":111,"type":21},80,[113],"NA","This study aims to find out if taking rice bran supplements can help reduce the painful mouth sores (oral mucositis) that often occur in patients with head and neck cancer who receive radiation therapy. The trial will include adult patients undergoing radiation treatment. Participants will be given rice bran supplements during their therapy to see if it can lessen these side effects and improve their overall quality of life.",[116,28,117],"Radiation-Induced Oral Mucositis","Head &Amp; Neck Squamous Cell Carcinoma",[116,119,120,121,122,123,124,125,126,127],"Oral Mucositis","Head and Neck Cancer","Rice Bran","Dietary Supplement","Radiation Therapy Side Effects","Quality of Life","Supportive Care","Antioxidants","Cancer Treatment Support","2025-11-17",{"date":130,"type":38},"2025-11-21",{"date":132,"type":38},"2023-01-15",{"date":134,"type":21},"2025-12-30",{"name":136,"class":45},"Christina Milad Lobos",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":4,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":148,"conditions":149,"keywords":152,"overallStatus":154,"whyStopped":4,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":4},"100598502","phase-1-safety-tolerability-pk-and-efficacy-of-cd-001-in-advanced-head--neck-cancers-100598502","NCT07072325","Safety, Tolerability, PK, and Efficacy of CD-001 in Advanced Head & Neck Cancers","A Clinical Study Assessing the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of CD-001 in Patients With Advanced Head & Neck Cancers","Inclusion Criteria:\n\n1. Age ≥ 18 years , regardless of gender.\n2. Patients with advanced head and neck cancer that are histologically or cytological confirmed, lacking standard therapy, progressing after adequate standard therapy, or intolerant of standard therapy.\n3. ECOG score ≤ 2.\n4. At least one measurable lesion as defined by RECIST v1.1.\n5. Expected survival ≥ 3 months.\n\nExclusion Criteria:\n\n1. Patients with known active central nervous system (CNS) and\u002For leptomeningeal metastases .\n2. Patients who have undergone major organ surgery within 4 weeks prior to the first dosing, or who are expected to require major surgery during this study, or who have severe unhealed wounds, trauma, ulcers, etc.\n3. Patients who have previously undergone a major organ transplant, bone marrow transplant, or allogeneic stem-cell transplant.\n4. Patients who have a past or current history of active or chronic autoimmune disease and who have required systemic therapy within the past 2 years or is receiving systemic therapy for an autoimmune or inflammatory disease.\n5. Patients who have received anti-tumor therapy within 4 weeks or 5 drug half-lives (whichever is shorter) prior to the first dosing.\n6. At screening as determined by the investigator, the presence of any serious or uncontrollable disease or associated risk.\n7. Patients with a history of ≥ Grade 3 (CTCAE) immune-related adverse events (irAEs) during prior anti-tumor therapy or permanent drug discontinuation due to irAEs.\n8. Patients who have had a pulmonary embolism within 6 months prior to first dosing or have interstitial pneumonia at screening.",{"count":145,"type":21},9,[147],"PHASE1","The goal of this prospective, single-center, open-label, dose-escalation study is to evaluate the safety, tolerability, and preliminary efficacy of CD-001 in patients with advanced head and neck cancers who have experienced disease progression (PD) or intolerance to standard systemic therapy (or lack thereof). The main question\\[s\\] it aims to answer:\n\n* What is the safety and tolerability profile of CD-001 across escalating doses?\n* What is the preliminary efficacy of CD-001 in this patient population?",[150,28,120,151],"Malignant Neoplasm","Advanced Head and Neck Carcinoma",[153],"head and neck cancer","NOT_YET_RECRUITING","2025-07-30",{"date":157,"type":38},"2025-08-03",{"date":159,"type":21},"2025-08-10",{"date":161,"type":21},"2028-08-31",{"name":163,"class":45},"West China Hospital"]