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NCT06494111
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)
Conditions: Lymphedema, Fibrosis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 295
Sponsor: M.D. Anderson Cancer Center
Location: MD Anderson Cancer Center Houston Texas
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 \
Source: ClinicalTrials.gov (NCT06494111). StuddyBuddy aggregates publicly available trial information.