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TRADstat: 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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Start Date
December 5, 2025
Primary Completion Date
October 1, 2028
Completion Date
October 1, 2028
Last Updated
March 3, 2026
48
ESTIMATED participants
Pravastatin 40 Mg Oral Tablet
DRUG
Lead Sponsor
Peter MacCallum Cancer Centre, Australia
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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