NCT07217938

Novel Treatment of Radiation Associated Dysphagia With Statins

TRADstat: Novel Treatment of Radiation Associated Dysphagia With Statins

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Peter MacCallum Cancer Centre, Australia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Radiation-associated Dysphagia
• Head &Amp; Neck Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-05
• Primary completion: 2028-10-01
• Completion: 2028-10-01
• First posted: 2025-10-20
• Last updated: 2026-03-03

Locations

1 site across 1 country: Australia