Systemic Therapy of Open-label Prophylactic Pravastatin or Pentoxifylline/Tocopherol Prevention of Lymphedema Advancing to Eventual Fibrosis: an Interventional Registry-embedded Bayesian Randomized Trial for Radiation Sequelae (STOP4-LATE-FIBROSE)
Trial Parameters
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Brief Summary
To learn if pentoxifylline and vitamin E or pravastatin can reduce radiation-induced lymphedema/fibrosis.
Eligibility Criteria
Inclusion Criteria: • Untreated T0-T4N0-3M0 oropharyngeal squamous carcinoma. 1. Dispositioned to radiotherapy with prescribed dose to unilateral or bilateral neck(s). 2. Creatinine clearance \>30mL/min 3. Age ≥18 years. Because no dosing or adverse event data are currently available on the use of pentoxifylline/pravastatin in participants \<18 years of age, children are excluded from this study 4. ECOG performance status ≤2 (Karnofsky ≥60%,) 5. Participants must have adequate organ and marrow function as defined below * absolute neutrophil count ≥1,000/mcL * platelets ≥100,000/mcL * total bilirubin ≤ institutional upper limit of normal (ULN) * AST(SGOT)/ALT(SGPT) ≤3 x institutional ULN * creatinine ≤1.5 x institutional ULN 6. The effects of pentoxifylline/pravastatin on the developing human fetus are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for