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

Launched by M.D. ANDERSON CANCER CENTER · Apr 2, 2025

Keywords

ClinConnect Summary

The clinical trial titled "Reverse-fibrose" is studying whether a specific medication can help treat or prevent lymphedema (swelling) and fibrosis (thickening or scarring of tissue) that can occur after radiation therapy in survivors of head and neck cancer. Researchers will compare different medications to see which one is the most effective in reducing these side effects that some patients experience long after their cancer treatment.

To participate in this trial, individuals must have a history of head and neck cancer and should not have any active disease. They also need to have previously received radiation therapy that was strong enough to potentially cause these side effects. Other important factors include being a woman who is not pregnant, and not having certain health issues like severe liver disease or heart problems. If eligible, participants can expect to receive careful monitoring and support throughout the study as researchers evaluate the effectiveness of the medications being tested. This trial is not yet recruiting participants, but it aims to provide valuable information that could improve the quality of life for cancer survivors dealing with these challenging side effects.

Gender

FEMALE

Eligibility criteria

• • Eligibility Criteria Eligibility criteria (observational registry or randomization)
• • 1. Prior history of head and neck cancer with no active disease.
• • 2. Treated previously with radiotherapy with prescribed dose (greater or equal to 30Gy) to unilateral or bilateral neck(s)
• • 3. Detectable CTC-AE G2+ lymphedema/fibrosis at \>6 months post-radiotherapy.
• • 4. No active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism, nor history of ulcers.
• • 5. No history of myopathy/rhabdomyolysis.
• • 6. Creatinine clearance \<30mL/min.
• • 7. No history of acute myocardial infarction or severe coronary disease.
• • 8. Non-pregnant/post-menopausal, or male.
• • 9. No history of diabetes mellitus
• • 10. Allergy/hypersensitivity to HMG Co-A reductase inhibitor and/or xanthine derivatives, e.g., caffeine, theophylline, theobromine
• • 11. No contraindications for magnetic resonance imaging a Subject to the discretion of the treating physician and Principal Investigator (PI), as the MRI may be optional
• • Exclusion Criteria
• • 1. Active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism.
• • 2. History of myopathy/rhabdomyolysis.
• • 3. History of acute myocardial infarction or severe coronary disease.
• • 4. Pregnant/post-menopausal, or male.
• • 5. History of diabetes mellitus.
• • 6. Allergy/hypersensitivity to Hydroxymethylglutaryl-coenzyme A (HMG Co-A) reductase inhibitor and/or xanthine derivatives, e.g., caffeine, theophylline, theobromine.
• • 7. Contraindications for MRI Subject to the discretion of the treating physician and Principal Investigator (PI), as the MRI may be optional
• • 8. Participants who are receiving any other investigational agents.
• • 9. History of allergic reactions attributed to compounds of similar chemical or biologic composition to statins, hemorheologic agents or other agents used in study
• • 10. Participants with psychiatric illness/social situations that would limit compliance with study requirements.