Comparing Medications to Treat or Prevent Radiation-Related Lymphedema and Fibrosis in Female Head and Neck Cancer Survivors

What this Trial Is About

Researchers are evaluating medications to treat or prevent lymphedema and fibrosis caused by radiation therapy in female survivors of head and neck cancer. This Phase 2 trial aims to compare different drugs to find the most effective therapy for reducing these side effects, focusing on both clinician assessments and patient-reported outcomes over a 12-month period. Participants will be randomly assigned to one of several groups receiving different drug treatments, including Pravastatin, Pentoxifylline combined with Vitamin E tocopherol, Ketoprofen, Pirfenidone, or standard care without pharmacologic intervention. Each treatment is given orally daily for 12 months. The study uses a double-blind design to compare the effects of these agents on radiation-related fibrosis and lymphedema. During the trial, participants will undergo various assessments including clinician-rated evaluations of fibrosis and lymphedema, imaging studies like MRI and swallowing function tests, and patient questionnaires measuring symptoms and quality of life. Safety and adverse events will be monitored throughout the study, which lasts about one year after randomization. The research team will analyze these measures to determine the relative usefulness of each drug in managing radiation-related complications.

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