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Hemorrheologic agent

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

Phase 2
Waitlist Available
Led By Clifton Fuller, MD,PHD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients dispositioned to radiotherapy with prescribed dose to unilateral or bilateral neck(s)
Age ≥18 years. Children are excluded from this study
Must not have
Active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism
History of myopathy/rhabdomyolysis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion; an average of 1 year.
Awards & highlights
No Placebo-Only Group

Summary

"This trial aims to see if pentoxifylline and vitamin E or pravastatin can help reduce lymphedema and fibrosis caused by radiation."

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects could include digestive issues, skin reactions, or liver enzyme changes from tocopherol; muscle pain, nausea, headache from pravastatin; and dizziness or gastrointestinal discomfort from pentoxifylline.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for radiotherapy targeting my neck.
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I am 18 years old or older.
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I can care for myself but may not be able to do active work.
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My blood counts and liver/kidney functions are within normal ranges.
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My cancer is in the oropharynx and hasn't spread to distant parts of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe liver disease, cirrhosis, or active alcoholism.
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I have a history of muscle disease or severe muscle breakdown.
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I have had a heart attack or severe heart disease.
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I am either pregnant, post-menopausal, or male.
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I have a history of diabetes.
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I am allergic to certain cholesterol medications and/or xanthine derivatives.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion; an average of 1 year.
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and adverse events (AEs)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pravastatin
2010
Completed Phase 4
~11530
Pentoxifylline
2021
Completed Phase 4
~1080
Tocopherol
1993
Completed Phase 4
~220

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
3,066 Previous Clinical Trials
1,801,950 Total Patients Enrolled
Clifton Fuller, MD,PHDPrincipal InvestigatorM.D. Anderson Cancer Center
~197 spots leftby May 2029
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