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

Inclusion Criteria12

• Eligibility Criteria Eligibility criteria (observational registry or randomization)
• Prior history of head and neck cancer with no active disease.
• Treated previously with radiotherapy with prescribed dose (greater or equal to 30Gy) to unilateral or bilateral neck(s)
• Detectable CTC-AE G2+ lymphedema/fibrosis at \>6 months post-radiotherapy.
• No active liver disease (Child-Pugh class B-C), cirrhosis, nor active alcoholism, nor history of ulcers.
• No history of myopathy/rhabdomyolysis.
• Creatinine clearance \<30mL/min.
• No history of acute myocardial infarction or severe coronary disease.
• Non-pregnant/post-menopausal, or male.
• No history of diabetes mellitus
• Allergy/hypersensitivity to HMG Co-A reductase inhibitor and/or xanthine derivatives, e.g., caffeine, theophylline, theobromine
• 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