Status:
NOT_YET_RECRUITING
Novel Treatment of Radiation Associated Dysphagia With Statins
Lead Sponsor:
Peter MacCallum Cancer Centre, Australia
Conditions:
Radiation-associated Dysphagia
Head &Amp; Neck Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- Patient has provided written informed consent using the TRADstat PICF
- Patients 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 RAD using validated cut-offs (PAS score \> 3 and/or DIGEST grading ≥ 2), identified on a VFSS conducted within the last 12 months
- Adequate kidney function defined as estimated glomerular filtration rate (eGFR) ≥ 40 ml/min
- Adequate hepatic function defined as:
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels less than 2 times the upper normal limit (ULN)
- Bilirubin level at least 1.5 times lower than the ULN
- Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2 (Appendix 1)
Exclusion
- Known hypersensitivity to pravastatin and/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 medication
- Currently taking prohibited medicines (long-term steroids or drugs listed under Section 8.4)
- History of severe heart failure; a history of muscle toxicity during previous treatments with fibrates or statins; a history of hereditary muscle diseases
- Known medical condition(s) that may impact swallowing function (e.g., stroke, neurological conditions, tracheostomy)
- Pregnant or breastfeeding
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2028
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT07217938
Start Date
December 1 2025
End Date
October 1 2028
Last Update
October 17 2025
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