NCT07217938 Novel Treatment of Radiation Associated Dysphagia With Statins
| NCT ID | NCT07217938 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Peter MacCallum Cancer Centre, Australia |
| Condition | Radiation-associated Dysphagia |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2025-12-05 |
| Primary Completion | 2028-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 48 participants in total. It began in 2025-12-05 with a primary completion date of 2028-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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
Inclusion Criteria: 1. Patient has provided written informed consent using the TRADstat PICF 2. Patients aged 18 years or older at screening 3. Received curative intent (chemo)radiotherapy to the nasopharynx, oropharynx, hypopharynx or larynx at least 2 years prior to screening 4. 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 5. Adequate kidney function defined as estimated glomerular filtration rate (eGFR) ≥ 40 ml/min 6. 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 7. Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2 (Appendix 1) Exclusion Criteria: 1. Known hypersensitivity to pravastatin and/or any excipients 2. Diagnosis of myasthenia (muscle weakness) 3. History of head or neck surgery, other than excisional biopsy or post treatment neck dissection 4. Known active malignancy 5. Currently taking statin medication 6. Currently taking prohibited medicines (long-term steroids or drugs listed under Section 8.4) 7. History of severe heart failure; a history of muscle toxicity during previous treatments with fibrates or statins; a history of hereditary muscle diseases 8. Known medical condition(s) that may impact swallowing function (e.g., stroke, neurological conditions, tracheostomy) 9. Pregnant or breastfeeding
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07217938 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Radiation-associated Dysphagia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07217938 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07217938 currently recruiting?
Yes, NCT07217938 is actively recruiting participants. Contact the research team at Jacqui.Frowen@petermac.org for enrollment information.
Where is the NCT07217938 trial being conducted?
This trial is being conducted at Melbourne, Australia.
Who is sponsoring the NCT07217938 clinical trial?
NCT07217938 is sponsored by Peter MacCallum Cancer Centre, Australia. The trial plans to enroll 48 participants.