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)
M.D. Anderson Cancer Center
Summary
To learn if pentoxifylline and vitamin E or pravastatin can reduce radiation-induced lymphedema/fibrosis.
Description
* Primary Objectives Determine the relative utility of pentoxifylline/tocopherol or pravastatin to reduce clinician-rated radiation lymphedema/fibrosis. * Secondary Objectives Determine the relative effect size observed of pentoxifylline/tocopherol or pravastatin to reduce objective imaging-derived measures of radiation lymphedema/fibrosis-related sequalae. Determine the relative effect size observed of pentoxifylline/tocopherol or pravastatin to reduce patient-reported measures of toxicity associated with lymphedema/fibrosis-related sequalae.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugPravastatin
Given by PO
- DrugPentoxifylline
Given by PO
- DrugTocopherol
Given by PO
Location
- MD Anderson Cancer CenterHouston, Texas