RecruitingPhase 2NCT07217938

Novel Treatment of Radiation Associated Dysphagia With Statins

TRADstat: Novel Treatment of Radiation Associated Dysphagia With Statins


Sponsor

Peter MacCallum Cancer Centre, Australia

Enrollment

48 participants

Start Date

Dec 5, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a statin medication (a type of cholesterol drug commonly used for heart health) can help treat radiation-associated dysphagia — swallowing difficulties caused by radiation therapy to the head and neck. Many cancer survivors develop trouble swallowing years after radiation treatment. **You may be eligible if...** - You have had radiation therapy to the head or neck for cancer (nasopharynx, oropharynx, hypopharynx, or larynx) at least 2 years ago - You are currently experiencing moderate-to-severe swallowing problems caused by the radiation - Your swallowing difficulty was confirmed on a swallowing test (videofluoroscopic swallow study) within the last 12 months - Your kidney and liver function are adequate - You are 18 or older **You may NOT be eligible if...** - You are allergic to pravastatin or cannot take statins - You have muscle weakness (myasthenia) - You have had head or neck surgery (beyond minor biopsy or neck dissection) - You have an active cancer - You are already taking statin medication - You are taking long-term steroids or certain other prohibited medications Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPravastatin 40 Mg Oral Tablet

This trial will incorporate Pravastatin 40 mg as an off-label use for the treatment of radiation-associated dysphagia.


Locations(1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

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NCT07217938


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