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

Palo Alto (17 mi)

Overseen byClifton 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

I am scheduled for radiotherapy targeting my neck.

I am 18 years old or older.

I can care for myself but may not be able to do active work.

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

My cancer is in the oropharynx and hasn't spread to distant parts of my body.

Exclusion Criteria

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

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

I have had a heart attack or severe heart disease.

I am either pregnant, post-menopausal, or male.

I have a history of diabetes.

I am allergic to certain cholesterol medications and/or xanthine derivatives.

Treatment Details

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.

3Treatment groups

Experimental Treatment

Active Control

Group I: Group 2Experimental Treatment2 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 1Experimental Treatment1 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 3Active Control1 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: