[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Instituto Nacional de Cancer, Brazil\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":131},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,49,84,106],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100592187","photobiomodulation-in-radiodermatitis-in-people-with-breast-cancer-100592187",false,"NCT06990165","Photobiomodulation in Radiodermatitis in People With Breast Cancer","Efficacy of Photobiomodulation in the Prevention and Severity of Radiodermatitis in People With Breast Cancer Undergoing Adjuvant Radiotherapy","Inclusion Criteria:\n\n* Individuals aged 18 years or older with an indication for adjuvant radiotherapy for breast cancer treatment at National Cancer Institute (INCA-BRAZIL).\n\nExclusion Criteria:\n\n* Previous diagnosis of cancer or bilateral breast cancer.\n* Oncological treatment outside the institution.\n* Connective tissue disorders (such as scleroderma and lupus erythematosus).\n* Previous radiotherapy to the breast or chest wall.\n* Individuals unable to complete the questionnaires.\n* Individuals unable to receive photobiomodulation due to acute infections.","ALL","18 Years",{"count":19,"type":20},148,"ESTIMATED","INTERVENTIONAL",[23],"NA","Most breast cancer patients undergoing radiotherapy develop radiodermatitis, making it one of the most prevalent adverse events during cancer treatment. The severity of radiodermatitis can pose a life-threatening risk to patients, lead to functional limitations, delay treatment (pauses for tissue recovery), reduce the radiation dose, and negatively impact health-related quality of life. There is no consensus on the ideal strategy for preventing radiodermatitis.\n\nPhotobiomodulation is a non-invasive strategythat may stimulate skin regeneration and minimize radiodermatitis without interfering with cancer treatment, with minimal risk (it may cause rare allergic-type complications or discomfort due to material contact) and low cost for both the patient and the healthcare system, making this approach highly relevant.\n\nReducing the use of pharmaceuticals, the duration of radiotherapy treatment, and the costs associated with managing radiodermatitis will have socioeconomic and environmental impacts, as this is a sustainable, safe, and cost-effective therapeutic approach with high applicability and clinical reproducibility.\n\nAdditionally, it can later be expanded to other types of cancer. This study hypothesizes that photobiomodulation can prevent and reduce complications associated with radiodermatitis in breast cancer patients undergoing adjuvant radiotherapy.\n\nTherefore, the primary objective of this clinical trial is to assess the efficacy of photobiomodulation in preventing and reducing the severity of radiodermatitis in breast cancer patients receiving adjuvant radiotherapy at Hospital do Câncer III of the Brazilian National Cancer Institute.\n\nThe secondary objectives include evaluating the incidence and severity grades of radiodermatitis; comparing the influence of photobiomodulation, according to the intervention group, on the occurrence and severity of radiodermatitis, pain, edema\u002Flymphedema, paresthesia, functionality, skin quality, health-related quality of life, and sleep quality after radiotherapy; comparing the recovery time of radiodermatitis between groups; and assessing satisfaction, safety, and tolerability of photobiomodulation use.",[26,27],"Breast Cancer","Radio Dermatitis",[29,30,31,32,33,34,35],"Physical Therapy","Phototherapy","Low-Level Light Therapy","Radiodermatitis","Adverse effects","Radiotherapy Adjuvant","Breast Neoplasms","NOT_YET_RECRUITING","2025-05-16",{"date":39,"type":40},"2025-05-25","ACTUAL",{"date":42,"type":20},"2025-05",{"date":44,"type":20},"2029-04",{"name":46,"class":47},"Instituto Nacional de Cancer, Brazil","OTHER_GOV",2,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":62,"conditions":63,"keywords":69,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100539101","phase-1-ptcy-and-atg-for-msd-and-mud-transplants-100539101","NCT06299462","PTCy and ATG for MSD and MUD Transplants","Efficacy Evaluation of Post-transplant Cyclophosphamide-based Graft-versus-host Disease Prophylaxis with ATG, Calcineurin Inhibitor-free, for Matched-sibling or Matched-unrelated Transplantation","Inclusion Criteria:\n\n* Patient with (1) acute leukemia in first or second remission; (2) myelodysplasia with less than 20% blasts; (3) Hodgkin's or non-Hodgkin's lymphoma, in partial remission after salvage therapy\n* Who will receive a related or unrelated, HLA-compatible transplant;\n* Who is a transplant candidate with FluMel, FluTBI, CyTBI, BuCy or BuFlu conditioning;\n* Peripheral blood source;\n* Age between 18 and 60 years.\n\nExclusion Criteria:\n\n\\- Hepatic dysfunction (transaminases x2 the normal value)","60 Years",{"count":58,"type":20},50,[60,61],"PHASE1","PHASE2","Hematopoietic stem cell transplantation is a curative treatment for a number of benign and malignant hematologic diseases. One of the key parts of hematopoietic stem cell transplantation is the prophylaxis of graft-versus-host disease. Since the end of the 1970s, with the introduction of cyclosporine, calcineurin inhibitors (cyclosporine and tacrolimus) have become part of almost all prophylactic regimens, even though they are a group of drugs with a poor toxicity profile that requires monitoring. constant serum level. Since 2008, post-transplant cyclophosphamide has been introduced with great success, associated with a calcineurin inhibitor and mycophenolate, in the prophylaxis of graft-versus-host disease in haploidentical transplantation (50% matched).\n\nSince then, in view of this enormous success, efforts have been made to incorporate post-transplant cyclophosphamide in matched related and unrelated transplants, or with a mismatch.\n\nThis is a prospective, 2-arm, non-randomized study. Arm 1, with related donors, and arm 2, with unrelated donors. Patients will be allocated in these arms according to donor availability (patients with a matched-sibling donor will receive a matched-sibling transplant; patients with no related donors but with unrelated donors, an unrelated transplant).\n\nPatients who are ready for transplantation with matched-sibling or unrelated donors will be recruited to participate in the study.\n\nThe stem cell collection target will be 5E6 CD34\u002Fkg recipient weight for peripheral source. If a quantity greater than this is collected, the remainder will be cryopreserved according to the institutional protocol.\n\nGraft-versus-host disease prophylaxis will be performed on D+3 and D+4 with cyclophosphamide and with ATG on D-3 and D-2 for matched-sibling or unrelated donors transplants.",[64,65,66,67,68],"Acute Myeloid Leukemia","Acute Lymphoblastic Leukemia","Myelodysplastic Syndromes","Hodgkin Lymphoma","Non-hodgkin Lymphoma",[70,71,72,73],"posttransplant cyclophosphamide","ATG","calcineurin-free GVHD prophylaxis","graft-versus-host disease","RECRUITING","2025-02-21",{"date":77,"type":40},"2025-02-25",{"date":79,"type":40},"2024-06-14",{"date":81,"type":20},"2031-06-01",{"name":46,"class":47},1,{"id":85,"slug":86,"hasResults":11,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":92,"minAge":17,"maxAge":4,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":95,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":103,"leadSponsor":105,"locationsCount":83},"100567647","phase-2-low-dose-pembrolizumab-plus-chemotherapy-for-the-first-line-treatment-of-persistent-recurrent-or-metastatic-cervical-cancer-100567647","NCT06670911","Low-dose Pembrolizumab Plus Chemotherapy for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer.","A Phase II Trial of Low-dose Pembrolizumab Plus Chemotherapy for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer - ACCESS I","ACCESS-I","Inclusion Criteria:\n\n1. ) Female participants aged 18 years and older\n2. ) Patients with persistent, recurrent, or metastatic squamous cell, adenocarcinoma, or adenosquamous cervical cancer, with PD-L1 CPS ≥ 1 expression, who have not received prior chemotherapy and are ineligible for curative surgery and\u002F or radiotherapy. Prior chemotherapy used as a radiosensitizer and completed at least 2 weeks before the scheduled date for C1D1 with resolution of all treatment-related toxicities is allowed. Adverse events due to prior treatments must be resolved to ≤ grade 1 or the participant's baseline. Neuropathy ≤ grade 2 or alopecia of grade ≤ 2 are eligible.\n3. ) Not pregnant or breastfeeding a ) Fertile-age women with the potential to become pregnant must agree to follow contraceptive guidance during treatment and for at least 120 days after the last dose of pembrolizumab and 210 days after the last dose of chemotherapy. Abstinence is acceptable if it is the participant's usual lifestyle and preferred contraception.\n4. ) The participant (or legal representative, if applicable) must provide written informed consent for the study. The participant may also provide consent for future biomarker research. However, the participant may participate in the main study without participating in future biomarker research.\n5. ) Have measurable disease according to RECIST 1.1 criteria, as assessed by the local investigator\u002Fradiologist. Lesions located in a previously irradiated area are considered measurable only if progression has been demonstrated.\n6. ) Have an archived tumor tissue sample (recurrent or metastatic cervical cancer) no older than 4 years or provide a biopsy of a previously unirradiated tumor lesion for prospective PD-L1 status determination, since only participants with PD-L1 expression CPS ≥ 1 will be included in the study.\n7. ) Performance Status\u002FEastern Cooperative Oncology Group (ECOG) of 0 to 1 within 7 days prior to C1D1\n8. ) Have adequate organ function, as indicated by the following laboratory values within 7 days prior to C1D1: a ) Absolute neutrophil count (ANC) ≥ 1,500\u002FmcL; b ) Platelets ≥ 100,000\u002FmcL; c ) Hemoglobin ≥ 9.0 g\u002FdL - The criterion must be met without erythropoietin dependence and without transfusion in the last 2 weeks prior to Cycle 1 Day 1; d ) Creatinine ≤ 1.5 x upper limit of normal or creatinine clearance ≥ 60 mL\u002Fmin for participants with creatinine levels \\> 1.5 x upper limit of normal - creatinine clearance (CrCl) should be calculated according to institutional standard using the Cockcroft-Gault formula; d ) Total serum bilirubin ≤ 1.5 x upper limit of normal; e ) AST and ALT ≤ 2.5 x upper limit of normal or ≤ 5 x upper limit of normal for participants with hepatic metastases; f ) International Normalized Ratio (INR) or Prothrombin Time (PT), Activated Partial Thromboplastin Time (aPTT) or Partial Thromboplastin Time (PTT) ≤ 1.5 x upper limit of normal, unless the participant is receiving anticoagulant, provided that PT or aPTT is within the therapeutic range for the intended use of anticoagulants.\n\nExclusion Criteria:\n\n1. ) Positive urine pregnancy test within 72 hours prior to C1D1. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required;\n2. ) Presence of known active central nervous system metastases and\u002For carcinomatous meningitis. Participants with known brain metastases may be included provided that the brain metastases have been previously treated (except with chemotherapy) and are radiographically stable. To demonstrate radiographic stability of previously treated brain metastases, a minimum of two post-treatment brain imaging evaluations are required: 1) The first brain image should be acquired after completion of the treatment of brain metastases. 2) The second image should be obtained during screening (i.e., within 28 days prior to the scheduled C1D1 date) and \\>4 weeks after the prior post-treatment brain image.Known brain metastases are considered active if any of the following criteria apply: a ) The brain image obtained during screening shows progression of existing metastases or the appearance of new lesions compared to brain images taken at least 4 weeks earlier b ) The neurological symptoms attributed to brain metastases have not returned to baseline; c) Steroid doses exceeding 10 mg of prednisone daily (or equivalent) were used to treat symptoms related to brain metastases within 28 days prior to the scheduled C1D1 date.\n3. ) Presence of other known malignancies within the past 3 years. Participants with basal cell carcinoma or squamous cell carcinoma of the skin who have undergone potentially curative therapy are not excluded.\n4. ) Having a diagnosis of immunodeficiency or being on chronic systemic steroid therapy (at doses greater than 10 mg daily prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the scheduled C1D1 date.\n5. ) Having an active autoimmune disease that has required systemic treatment within the past 2 years (i.e., with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement for adrenal or pituitary insufficiency) is permitted.\n6. ) History of non-infectious pneumonitis requiring steroid use.\n7. ) Having an active infection requiring systemic therapy.\n8. ) Having a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required.\n9. ) Having a known history of hepatitis B (defined as positive hepatitis B surface antigen \\[HBsAg\\]) or known active hepatitis C virus (defined as detectable HCV RNA \\[qualitative\\]). No testing for hepatitis B and hepatitis C is required .\n10. ) Having a known history of active tuberculosis.\n11. ) Having received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or any other immune checkpoint inhibitor (CTLA-4, OX40, LAG3, etc.).\n12. ) Having received prior systemic chemotherapy for the treatment of advanced cervical cancer (chemotherapy used as a radiosensitizer and completed at least 2 weeks prior to the scheduled start date of cycle 1, day 1).\n13. ) Not having recovered adequately from toxicities and\u002For complications of major surgery prior to the scheduled start date of cycle 1, day 1.\n14. ) Having received radiotherapy within 2 weeks prior to the scheduled start date of cycle 1, day 1.\n15. ) Having received a live vaccine within 30 days prior to the scheduled start date of cycle 1, day 1 (measles, mumps, rubella, varicella\u002Fzoster, yellow fever, rabies, Bacillus Calmette-Guérin (BCG), typhoid fever vaccine, etc.). Seasonal influenza vaccines are permitted.\n16. ) Having a contraindication or hypersensitivity to any component of carboplatin, paclitaxel, or cisplatin\n17. ) Currently participating or has participated in a study of an investigational agent or used an experimental device within 4 weeks prior to the scheduled start date of cycle 1, day 1.\n18. ) History of allogeneic solid organ\u002Ftissue transplantation.\n19. ) Having a known psychiatric disorder or substance abuse that may interfere with the study requirements.\n20. ) To have a history or current evidence of any condition, therapy, or laboratory abnormality that could confound the study results, interfere with participation, in the opinion of the treating investigator.","FEMALE",{"count":94,"type":20},44,[61],"This is a phase II single-arm study of low-dose pembrolizumab (100mg, fixed-dose) plus chemotherapy in women aged 18 years or older with histologically confirmed persistent, recurrent, or metastatic cervical cancer who are ineligible for curative-intent treatment (surgery and\u002For radiation therapy) and who have not been previously treated with systemic chemotherapy, with the exception of chemotherapeutic agents used as radiosensitizers (cisplatin or carboplatin concurrent with radiation therapy).",[98],"Persistent, Recurrent, or Metastatic Cervical Cancer","2025-02-20",{"date":101,"type":40},"2025-02-24",{"date":99,"type":40},{"date":104,"type":20},"2028-04",{"name":46,"class":47},{"id":107,"slug":108,"hasResults":11,"nctId":109,"briefTitle":110,"officialTitle":111,"acronym":4,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":118,"conditions":119,"keywords":122,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":48},"100521595","phase-3-low-power-laser-therapy-as-prevention-of-oral-mucositis-and-oropharyngeal-pain-in-patients-undergoing-allogenetic-hsct-100521595","NCT06071637","Low Power Laser Therapy As Prevention Of Oral Mucositis And Oropharyngeal Pain In Patients Undergoing Allogenetic HSCT","Low Power Laser Therapy As Prevention Of Oral Mucositis And Oropharyngeal Pain In Patients Undergoing Allogenetic Hematopoietic Stem Cell Transplantation.","Inclusion Criteria:\n\n* Patients with indication for allogeneic HSCT;\n* Patients over 18 years old;\n* Patients with intact oral mucosa on the first day of conditioning (D-7);\n* Patients able to cooperate with treatment;\n* Patients capable of performing the oral hygiene protocol;\n* Patients who agreed to participate in the study through the informed consent form (TCLE) in accordance with Resolution 466\u002F12 of the National Health Council.\n\nExclusion Criteria:\n\n* Patients who are receiving medication for the treatment and\u002For prevention of mucositis;\n* Patients who were not previously evaluated and released by INCA's Dentistry section team","100 Years",{"count":115,"type":20},84,[117],"PHASE3","Objective: To compare the effects of two low-power laser therapy protocols (application of a wavelength in the mouth, red region and another in the neck infrared region X simultaneous dual application of two wavelengths, red and infrared region in the mouth and neck) in the prevention of oral mucositis and oropharyngeal pain, dysphagia, TPN and opioid use in patients undergoing HSCT allogenic.\n\nMaterials and methods: This is a phase III, double-blind, randomized study that will use LBP to prevent oral mucositis and oropharyngeal pain in two protocols with different dosimetry (divided into Group A and Group B). Patients will be included enrolled at the Bone Marrow Transplant Center - Cancer Hospital I - INCA, with indication of allogeneic HSCT, over 18 years old, able to cooperate with the treatment and perform the oral hygiene protocol, who present oral mucosa complete on the first day of conditioning (D-7) and who agree to participate in the study through the term of free and clarified informed consent. The randomization will be carried out in permuted blocks using the REDCap® program by a member of the non-blind team. In group A, extraoral applications will be carried out with the issuance of radiation in the infrared region of the electromagnetic spectrum (808nm) and intraorally in the red region of the electromagnetic spectrum (660nm). In group B, the extra applications and intraoral will be performed with simultaneous double radiation emission in the regions red and infrared of the electromagnetic spectrum (660nm\u002F808nm). for both groups will use the device from DMC (São Carlos, São Paulo, Brazil), with a indium gallium aluminum phosphide (InGaAlP) and aluminum gallium arsiade diode (AlGaAs), with a power of 100mW and a beam area of 0.09842 cm². The LBP will be performed by a dental surgeon, on weekdays, starting on D-7 and end on the day of the \"marrow take\" (patient presents 500 neutrophils for three days consecutive). The region treated in extraoral applications will be the carotid triangle bilateral, bounded by the superior belly of the omohyoid, posterior belly of the digastric and by the anterior border of the sternocleidomastoid muscle; and intraorally, the mucous membranes right and left cheeks, lower and upper lips, upper and lower labial mucous membranes, right and left lateral borders of the tongue, lingual belly, buccal floor and soft palate. Patients will be evaluated daily (weekdays per week) for oral mucositis, pain in the oral cavity and oropharynx, dysphagia, use of total parenteral nutrition and opioids. Patients and dentists responsible for evaluating patients will be blinded to the study, that is, they will not know about the treatment that the patient will receive. The data from interest will be collected from the physical records and electronic systems of the institution, through standardized forms and will be included in REDCap®. Statistical analyzes will be carried out using the latest available version of the R software for Windows. It will be A descriptive analysis of the data found in the clinical, laboratory and sociodemographic data. To compare the incidence of mucositis, dysphagia, pain (treating the variables as dichotomous), the chi-square test of Pearson. Statistical analyzes will be performed using the latest available version of the R software for Windows. A descriptive analysis of the data found will be carried out in clinical examination, laboratory and sociodemographic data. To compare the incidence of mucositis, dysphagia, pain (treating the variables as dichotomous), the Pearson's chi-square test. Mucositis-free survival analyzes (any degree) and dysphagia (any degree) will be performed by the Kaplan-Meier method and the curves compared by log-rank test. The time interval between the start of conditioning and date of first grade ≥1 mucositis or dysphagia to date of the \"marrow take\" (500 neutrophils in the peripheral blood for three consecutive days). Participants without mucositis or dysphagia will be censored on the date of marrow collection. Tests of hypothesis with p-value \\< 0.05. The sample calculation predicted 82 patients, who will be evaluated by intention of treatment, counting with 10% loss to reach 37 patients in group A and 37 in group B. The estimate of the presence of oral mucositis grades 2, 3 and 4 in group A is 36.8% and in group B 10%. The estimate of the presence of dysphagia grades 3 and 4 (or pain in oropharynx grades 2 and 3) in group A is 80% and in group B 40%. the statistical test The two-tailed Z test with pooled variance was used, with a type 1 error of 0.05 and the error type 2 of 0.20. This research project was approved by the Research Ethics Committee responsible (CAAE 67172223.9.0000.5274, opinion No. 5.947.434) and will be conducted in a according to Resolution 466\u002F12 of the National Health Council and the Good News Guide Clinical Practices.",[120,31,121],"Hematopoietic Stem Cell Transplantation","Stomatitis",[120,31,121],"2023-10-02",{"date":125,"type":40},"2023-10-06",{"date":127,"type":40},"2023-08-01",{"date":129,"type":20},"2027-02-28",{"name":46,"class":47},""]