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TrialNCT07217938

Novel Treatment of Radiation Associated Dysphagia With Statins

Status
RECRUITING
Phase
PHASE2
Last update posted
09/04/2026
Start
12/05/2025
Sponsor
Peter MacCallum Cancer Centre, Australia
Specialties
cardiology, otolaryngology, oncology

Conditions: Radiation-associated Dysphagia; Head &Amp; Neck Cancer

Brief summary

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.

Protocol documents and results are not hosted here. Verify every detail on ClinicalTrials.gov.

Clinical Evidence