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Recruiting NCT06912763

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

Conditions: Fibrosis Syndrome, Lymphedema, Head &Amp; Neck Cancer, Fibrosis

Sex: Female
Healthy volunteers: No
Phase: PHASE2
Enrollment: 250
Sponsor: M.D. Anderson Cancer Center

Location: MD Anderson Cancer Center Houston Texas

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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06912763). StuddyBuddy aggregates publicly available trial information.