NCT06912763 Reversing External-beam Radiotherapy-associated Fibrosis Syndrome: an Interventional Bayesian Adaptive Randomized-controlled Orphan Drug Platform Trial for Orodental Sequelae (Reverse-fibrose)
| NCT ID | NCT06912763 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Fibrosis Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-08-08 |
| Primary Completion | 2030-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 250 participants in total. It began in 2025-08-08 with a primary completion date of 2030-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Clifton Fuller, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT06912763 clinical trial?
This trial is open to female participants only, studying Fibrosis Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06912763 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06912763 currently recruiting?
Yes, NCT06912763 is actively recruiting participants. Contact the research team at cdfuller@mdanderson.org for enrollment information.
Where is the NCT06912763 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06912763 clinical trial?
NCT06912763 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Clifton Fuller, MD at M.D. Anderson Cancer Center. The trial plans to enroll 250 participants.