Actively Recruiting
Novel Treatment of Radiation Associated Dysphagia With Statins
Led by Peter MacCallum Cancer Centre, Australia · Updated on 2026-03-03
48
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Novel Treatment of Radiation Associated Dysphagia With Statins
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent using the TRADstat PICF
- Aged 18 years or older at screening
- Received curative intent (chemo)radiotherapy to the nasopharynx, oropharynx, hypopharynx or larynx at least 2 years prior to screening
- Moderate-severe radiation-associated dysphagia with PAS score > 3 and/or DIGEST grading 2 identified on a VFSS within the last 12 months
- Adequate kidney function with estimated glomerular filtration rate (eGFR) 2 40 ml/min
- Adequate liver function with AST and ALT less than 2 times the upper normal limit and bilirubin at least 1.5 times lower than the upper normal limit
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2
You will not qualify if you...
- Known hypersensitivity to pravastatin or any excipients
- Diagnosis of myasthenia (muscle weakness)
- History of head or neck surgery other than excisional biopsy or post-treatment neck dissection
- Known active malignancy
- Currently taking statin medications
- Currently taking prohibited medicines such as long-term steroids
- History of severe heart failure, muscle toxicity from fibrates or statins, or hereditary muscle diseases
- Medical conditions affecting swallowing like stroke, neurological conditions, or tracheostomy
- Pregnant or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
Research Team
J
Jacqui Frowen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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