Tocopherol + Pravastatin + Pentoxifylline for Radiation-Induced Lymphedema and Fibrosis

Recruiting in Palo Alto (17 mi)

Overseen by Clifton D. Fuller

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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

Eligibility Criteria

This trial is for individuals who have developed lymphedema or fibrosis as a result of radiation therapy. The specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and may be required to have a history of radiation treatment.

Inclusion Criteria

Creatinine clearance >30mL/min

I am scheduled for radiotherapy targeting my neck.

My blood counts and liver/kidney functions are within normal ranges.

Exclusion Criteria

I do not have severe liver disease, cirrhosis, or active alcoholism.

Contraindications for MRI

I have a history of muscle disease or severe muscle breakdown.

Participant Groups

The study is testing whether pentoxifylline combined with vitamin E (tocopherol) or the drug pravastatin can help reduce symptoms of lymphedema and fibrosis caused by radiation. It's an interventional study where patients are likely randomly assigned to different treatments.

Group I: Group 2 Experimental Treatment 2 Interventions

Beginning at 6 months after radiation therapy, participants will take pentoxifylline and vitamin E by mouth 3 times a day for about 12 months.

Group II: Group 1 Experimental Treatment 1 Intervention

Beginning at 6 months after radiation therapy, participants will take 40 mg pravastatin by mouth 1 time a day for about 12 months.

Group III: Group 3 Active Control 1 Intervention

Participants will not be given any of the study drugs, as this is the control group.

Pentoxifylline is already approved in United States, Canada, European Union for the following indications:

🇺🇸 Approved in United States as Trental for:

• Intermittent claudication

🇨🇦 Approved in Canada as Trental for:

• Intermittent claudication

🇪🇺 Approved in European Union as Trental for:

• Intermittent claudication

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

MD Anderson Cancer Center Houston, TX

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center Lead Sponsor

References