Actively Recruiting

Phase 2
FEMALE
NCT06912763

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

Led by M.D. Anderson Cancer Center · Updated on 2026-01-26

250

Participants Needed

1

Research Sites

394 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Prior history of head and neck cancer with no active disease
  • Previously treated with radiotherapy with a prescribed dose of 30 Gy or more to one or both necks
  • Detectable grade 2 or higher lymphedema or fibrosis more than 6 months after radiotherapy
  • No active liver disease (Child-Pugh class B or C), cirrhosis, active alcoholism, or history of ulcers
  • No history of myopathy or rhabdomyolysis
  • Creatinine clearance of 30 mL/min or more
  • No history of acute myocardial infarction or severe coronary disease
  • Female who is non-pregnant or post-menopausal, or male
  • No history of diabetes mellitus
  • No allergy or hypersensitivity to HMG Co-A reductase inhibitors or xanthine derivatives (e.g., caffeine, theophylline, theobromine)
  • No contraindications to magnetic resonance imaging, subject to physician discretion
Not Eligible

You will not qualify if you...

  • Active liver disease (Child-Pugh class B or C), cirrhosis, or active alcoholism
  • History of myopathy or rhabdomyolysis
  • History of acute myocardial infarction or severe coronary disease
  • Pregnant females; post-menopausal females or males are excluded
  • History of diabetes mellitus
  • Allergy or hypersensitivity to HMG Co-A reductase inhibitors or xanthine derivatives
  • Contraindications to magnetic resonance imaging, subject to physician discretion
  • Receiving other investigational agents
  • History of allergic reactions to similar compounds used in the study
  • Psychiatric illness or social situations limiting compliance with study requirements

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

C

Clifton Fuller, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

5

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