[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"fibrosis-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:fibrosis-syndrome":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":4,"maxAge":4,"enrollmentInfo":16,"targetDuration":4,"studyType":19,"phases":20,"briefSummary":22,"conditions":23,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":5},"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",false,"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":17,"type":18},250,"ESTIMATED","INTERVENTIONAL",[21],"PHASE2","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.",[24,25,26,27],"Fibrosis Syndrome","Lymphedema","Head &Amp; Neck Cancer","Fibrosis","RECRUITING","2026-01-23",{"date":31,"type":32},"2026-01-26","ACTUAL",{"date":34,"type":32},"2025-08-08",{"date":36,"type":18},"2033-03-01",{"name":38,"class":39},"M.D. Anderson Cancer Center","OTHER"]