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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
This trial will incorporate Pravastatin 40 mg as an off-label use for the treatment of radiation-associated dysphagia.
Efficacy of the pravastatin to treat radiation-associated dysphagia
A Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) grade decrease of at least 1-point after 12 months of pravastatin from registration. The DIGEST scale ranges between 0 to 4, with 4 being the worst outcome.
Time frame: From enrolment to the end of 12 months of pravastatin use
Feasibility of the use of pravastatin to treat radiation-associated dysphagia
Percentage of eligible patients who consent to recruitment and percentage of recruited (registered) patients who remain on pravastatin for 12 months and complete the 6-month follow-up assessment
Time frame: From the start of pravastatin therapy to 6 months of follow up after the completion of 12 months of pravastatin therapy (total estimated time duration 18 months)
Acceptability of trial methods and procedures and acceptability of pravastatin
Acceptability of trial methods and procedures, and acceptability of pravastatin: Theoretical Framework of Acceptability (TFA) questionnaire total score. The TFA used in this study ranges between 11 - 55 and higher scores represent better acceptability.
Time frame: From the start of pravastatin therapy to 6 months of follow up after the completion of 12 months of pravastatin therapy (total estimated time duration 18 months)
Tolerability of pravastatin
Tolerability of pravastatin: percentage of patients who cease pravastatin (patient or clinician choice) due to pravastatin related toxicity using Common Toxicity Criteria for Adverse Events, Version 5.0 (CTCAE v5.0), and the range is 0 to 5, with 5 being the worst outcome
Time frame: From the start of pravastatin therapy until the completion of 12 months of therapy
Safety of pravastatin use
Safety of pravastatin use: percentage of patients who experience ≥ Grade 2 toxicity (as per Common Toxicity Criteria for Adverse Events, Version 5.0 \[CTCAE v5.0\], and the range is 0 to 5, with 5 being the worst outcome)
Time frame: From the start of pravastatin therapy until the completion of 12 months of therapy
Immune-biomarker outcome
Immune-biomarker outcome: collection of 10 mL edta tube for the immune-biomarker analysis. Specific biomarker selection still under process.
Time frame: At baseline and after 12 months of pravastatin treatment.
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