drugset / Trial / NCT06912763

Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)

NCT06912763

Phase 2 Recruiting 250 enrolled M.D. Anderson Cancer Center
RandomizedSingle-groupDouble-blindSupportive care

Summary

To find out if adding medication can help treat or prevent lymphedema and/or 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.

Timeline

Start
2025-08-08
Primary completion
2031-03-01
Completion
2033-03-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketoprofen Small molecule 75 mg Oral
Subject Pentoxifylline Small molecule 400 mg Oral
Subject Pirfenidoneone Unknown 801 mg Oral
Subject Pravastatin (drug) Unknown 40 mg Oral
Subject Vitamin E Other / unclassified 1000 iu Oral