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 statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

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

Eligibility criteria

Qualifiers

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%,)

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Pravastatin
  • Pentoxifylline
  • Tocopherol

Treatment groups

295 Participants
are divided into 3 treatment groups

Sponsors and collaborators