RecruitingPhase 2

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)

United States295 participantsStarted 2025-02-13

Plain-language summary

To learn if pentoxifylline and vitamin E or pravastatin can reduce radiation-induced lymphedema/fibrosis.

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Dispositioned to radiotherapy with prescribed dose to unilateral or bilateral neck(s).
✓. Creatinine clearance \>30mL/min
✓. 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
✓. ECOG performance status ≤2 (Karnofsky ≥60%,)
✓. Participants must have adequate organ and marrow function as defined below

✕. Ability to understand and the willingness to sign a written informed consent document.
✕. Active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism.
✕. History of myopathy/rhabdomyolysis.
✕. History of acute myocardial infarction or severe coronary disease.
✕. Pregnant/post-menopausal, or male.
✕. History of diabetes mellitus.
✕. Allergy/hypersensitivity to Hydroxymethylglutaryl-coenzyme A (HMG Co-A) reductase inhibitor and/or xanthine derivatives, e.g., caffeine, theophylline, theobromine.
✕. Contraindications for MRI

Safety and adverse events (AEs)

Timeframe: Through study completion; an average of 1 year.

NCT IDNCT06494111

SponsorM.D. Anderson Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-05-01

Clifton Fuller, MD,PHD

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Dispositioned to radiotherapy with prescribed dose to unilateral or bilateral neck(s).
✓. Creatinine clearance \>30mL/min
✓. 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
✓. ECOG performance status ≤2 (Karnofsky ≥60%,)
✓. Participants must have adequate organ and marrow function as defined below

✕. Ability to understand and the willingness to sign a written informed consent document.
✕. Active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism.
✕. History of myopathy/rhabdomyolysis.
✕. History of acute myocardial infarction or severe coronary disease.
✕. Pregnant/post-menopausal, or male.
✕. History of diabetes mellitus.
✕. Allergy/hypersensitivity to Hydroxymethylglutaryl-coenzyme A (HMG Co-A) reductase inhibitor and/or xanthine derivatives, e.g., caffeine, theophylline, theobromine.
✕. Contraindications for MRI