Reversing radiotherapy-related fibrosis and lymphedema in head and neck cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Bayesian adaptive, randomized platform trial that compares multiple candidate drugs against standard of care to find the most effective therapy for radiation-associated fibrosis and lymphedema after head and neck cancer treatment. Participants are head and neck cancer survivors with clinician-detected grade 2 or higher lymphedema/fibrosis at least six months after receiving ≥30 Gy radiation. Primary outcomes include clinician-rated CTC-AE fibrosis scores and specialist-rated HN-ELAF scores at 12 months, plus imaging-based endpoints such as swallowing dysfunction (DIGEST) and quantitative T1 MRI changes. The platform design allows adaptive allocation to favor better-performing agents over time and to efficiently estimate relative effect sizes between arms.

Why it matters

Who can join: the full rules

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.

Where it's running

• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting

Study contacts

• Principal investigator: Clifton Fuller, MD — M.D. Anderson Cancer Center
• Study coordinator: Clifton Fuller, MD
• Email: cdfuller@mdanderson.org
• Phone: (832) 817-8568

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.