OncoMatch/Clinical Trials/NCT07217938
Novel Treatment of Radiation Associated Dysphagia With Statins
Is NCT07217938 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pravastatin 40 Mg Oral Tablet for radiation-associated dysphagia.
Treatment: Pravastatin 40 Mg Oral Tablet — 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.
Check if I qualifyExtracted eligibility criteria
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: radiation therapy — curative intent to nasopharynx, oropharynx, hypopharynx or larynx
Received curative intent (chemo)radiotherapy to the nasopharynx, oropharynx, hypopharynx or larynx at least 2 years prior to screening
Lab requirements
Kidney function
eGFR ≥ 40 ml/min
Liver function
AST and ALT < 2x ULN; bilirubin at least 1.5x lower than ULN
Adequate kidney function defined as eGFR ≥ 40 ml/min; Adequate hepatic function defined as: AST and ALT < 2x ULN; bilirubin at least 1.5x lower than ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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