Novel Treatment of Radiation Associated Dysphagia With Statins
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorPeter MacCallum Cancer Centre, Australia
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Pravastatin 40 Mg Oral Tablet
DrugThis trial will incorporate Pravastatin 40 mg as an off-label use for the treatment of radiation-associated dysphagia.
Treatment groups
48 Participants
are divided into 1 treatment groupGroup A: Single arm studyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of a 12 month trial investigating 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)2
Preliminary evidence of 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 useSecondary outcomes
1
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)2
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 therapy3
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 therapyOther outcomes
1
Clinician-rated penetration/aspiration
Clinician-rated penetration/aspiration: Penetration-Aspiration scale (PAS) score assessed via videofluoroscopy swallow studies (VFSS), the range is 1 to 8, with 8 representing the worst outcome.
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)2
Biomechanical swallowing measures
Bio-mechanical swallowing measures: using the Computational Analysis of Swallowing Mechanics (CASM) via VFSS, no specific range is available, however ; higher values represent better outcome.
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)3
Clinician-rated functional status
Clinician-rated functional status: Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) subscale scores, the range is between 0 to 100, with higher values representing better outcomes.
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)4
Trismus (limitations in mouth opening)
Trismus (limitations in mouth opening): Maximal-interincisal opening as measured using the TheraBite® Range-of-Motion scale, the range is between 0 to 70 mm, with higher values representing better outcomes.
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)Sponsors and contacts
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Source ClinicalTrials.gov