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