Pravastatin or Pentoxifylline for Lymphedema Prevention

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)

Recruiting Phase 2 Interventional Study
Lymphedema Fibrosis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Supportive Care
Participants needed
295 (estimated)
Sponsor
M.D. Anderson Cancer Center · Other
Who this trial is looking for

This trial is looking for adults with oropharyngeal cancer who will receive radiation therapy. Participants will take either pravastatin or pentoxifylline with vitamin E to see if it helps prevent swelling and tissue damage after radiation treatment.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old.
  • I have been diagnosed with oropharyngeal squamous carcinoma.
  • I will receive radiation therapy to my neck.
  • I have normal kidney function.
  • I am in good health according to performance status.
  • I can understand and sign the consent form.

You may not be able to join if

  • I have active liver disease or cirrhosis.
  • I have a history of muscle problems.
  • I have had a heart attack or serious heart disease.
  • I am pregnant or post-menopausal.
  • I have diabetes.
  • I am allergic to certain medications used in this study.
  • I cannot undergo an MRI.
  • I am currently taking other investigational drugs.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

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

Trial Locations
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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…
Contacts

Clifton Fuller, MD,PHD

(832) 817-8568

cdfuller@mdanderson.org

CONTACT