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OncoMatch/Clinical Trials/NCT06912763

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

Is NCT06912763 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for fibrosis syndrome.

Phase 2RecruitingM.D. Anderson Cancer CenterNCT06912763Data as of May 2026

Treatment: Pravastatin (drug) · Pentoxifylline · ketoprofen · Pirfenidoneone · tocopherolTo 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.

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Extracted eligibility criteria

Prior therapy

Must have received: radiation therapy

Treated previously with radiotherapy with prescribed dose (greater or equal to 30Gy) to unilateral or bilateral neck(s)

Lab requirements

Kidney function

Creatinine clearance <30mL/min

Liver function

No active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism

Cardiac function

No history of acute myocardial infarction or severe coronary disease

No active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism, nor history of ulcers. Creatinine clearance <30mL/min. No history of acute myocardial infarction or severe coronary disease.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • MD Anderson Cancer Center · Houston, Texas

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