Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07217938
PHASE2

Novel Treatment of Radiation Associated Dysphagia With Statins

Sponsor: Peter MacCallum Cancer Centre, Australia

View on ClinicalTrials.gov

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.

Official title: TRADstat: Novel Treatment of Radiation Associated Dysphagia With Statins

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

48

Start Date

2025-12-05

Completion Date

2028-10-01

Last Updated

2026-03-03

Healthy Volunteers

No

Interventions

DRUG

Pravastatin 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