Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)
M.D. Anderson Cancer Center
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.
Description
Primary Objectives 1. Determine the relative utility of candidate agents to reduce clinician-rated radiation lymphedema/fibrosis 1. Hyp 1: Participants receiving candidate agent(s) will exhibit a proportional lower rate of Common Toxicity Criteria- Adverse Event (CTC-AE v5.0) rating of Grade 2 or greater on either "Fibrosis deep connective tissue" or "Superficial soft tissue fibrosis" by formal clinician assessment at 12 months post-randomization. 2. Hyp 2: Participants receiving candidate agent(s) will exhibit a proportional lower rate of objective lymphedema/fibrosis rated as "modera…
Eligibility
- Age range
- Not specified
- Sex
- Female
- Healthy volunteers
- No
Eligibility Criteria Eligibility criteria (observational registry or randomization) 1. Prior history of head and neck cancer with no active disease. 2. Treated previously with radiotherapy with prescribed dose (greater or equal to 30Gy) to unilateral or bilateral neck(s) 3. Detectable CTC-AE G2+ lymphedema/fibrosis at \>6 months post-radiotherapy. 4. No active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism, nor history of ulcers. 5. No history of myopathy/rhabdomyolysis. 6. Creatinine clearance \<30mL/min. 7. No history of acute myocardial infarction or severe coronary…
Interventions
- DrugPravastatin (drug)
Given PO
- DrugPentoxifylline
Given PO
- Drugketoprofen
Given PO
- DrugPirfenidoneone
Given PO
- OtherStandard of Care (SOC)
SOC
- Drugtocopherol
Given PO
Location
- MD Anderson Cancer CenterHouston, Texas