RecruitingPhase 2NCT06912763

Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)


Sponsor

M.D. Anderson Cancer Center

Enrollment

250 participants

Start Date

Aug 8, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

To find out if adding medication can help treat or prevent lymphedema and/or fibrosis related to radiation therapy, in survivors of head and neck cancer. Researchers will compare these drugs to find the most effective therapy for preventing or limiting these side effects.


Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of medications — including a statin (cholesterol-lowering drug) and a drug that improves blood flow — can reduce lymphedema (swelling) and tissue scarring (fibrosis) in the neck that develops after radiation therapy for head and neck cancer. **You may be eligible if...** - You previously had head and neck cancer and are now cancer-free - You received radiation to your neck (at least 30 Gy) as part of your treatment - You have grade 2 or higher lymphedema or fibrosis in the neck, occurring more than 6 months after radiation - You are male or post-menopausal - You do not have diabetes, active liver disease, or heart disease **You may NOT be eligible if...** - You are currently pregnant or pre-menopausal (and female) - You have active liver disease, cirrhosis, or alcoholism - You have a history of heart attack or severe heart disease - You have a history of muscle breakdown disorder - You are allergic to statins or caffeine-related compounds - You have diabetes Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPravastatin (drug)

Given PO

DRUGPentoxifylline

Given PO

DRUGketoprofen

Given PO

DRUGPirfenidoneone

Given PO

OTHERStandard of Care (SOC)

SOC

DRUGtocopherol

Given PO


Locations(1)

MD Anderson Cancer Center

Houston, Texas, United States

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NCT06912763


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