Novel Treatment of Radiation Associated Dysphagia With Statins

The aim of this trial is to examine the feasibility, acceptability, and potential efficacy of a 12-month course of pravastatin as an antifibrotic agent for managing dysphagia (swallowing problems) in patients previously treated with radiotherapy for head and neck cancer (HNC). The purpose is to assess whether pravastatin, a medication approved in Australia for cholesterol management, can improve swallowing in people with long-term radiation-associated dysphagia following HNC treatment. The trial will recruit 48 patients, with an anticipated accrual period of approximately 6 months. Eligible patients will be identified from the Principal Investigator's current study, ERADICATE, or through referral by a radiation oncologist or speech pathologist diagnosing radiation-induced dysphagia. Participants will receive 40 mg of pravastatin daily for up to 12 months, with swallowing assessments conducted before, during, and after treatment.

NCT Number	NCT07217938
Lead Sponsor	Peter MacCallum Cancer Centre, Australia
Conditions	Radiation-associated Dysphagia, Head & Neck Cancer
Enrollment	48 participants
Start Date	2025-12-05
Primary Completion	2028-10-01 (estimated)
Study Completion	2028-10-01 (estimated)
Updated on ClinicalTrials.gov	2026-03-03