Pravastatin for long-term swallowing problems after head and neck radiotherapy
TRADstat: Novel Treatment of Radiation Associated Dysphagia With Statins
This study will test whether taking pravastatin daily for 12 months can improve long-term swallowing problems in people who had radiotherapy for head and neck cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Peter MacCallum Cancer Centre, Australia Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT07217938 on ClinicalTrials.gov |
What this trial studies
This Phase 2 interventional study will give 40 mg pravastatin daily for up to 12 months to 48 patients with moderate–severe radiation-associated dysphagia following curative-intent radiotherapy for head and neck cancer. Participants will be recruited from the investigator's ERADICATE study or referred by radiation oncologists and speech pathologists and must have dysphagia documented on a recent videofluoroscopic swallowing study (VFSS). Swallowing function and safety (including liver and kidney tests) will be measured before, during, and after treatment using standardized metrics such as PAS and DIGEST. The trial is designed to test feasibility, acceptability, and look for early signs that pravastatin's antifibrotic effects may improve swallowing to inform larger trials.
Who should consider this trial
Good fit: Adults (≥18 years) who had curative-intent radiotherapy to the nasopharynx, oropharynx, hypopharynx, or larynx at least two years earlier, with moderate–severe radiation-associated dysphagia on VFSS, adequate liver and kidney function, and ECOG performance status 0–2.
Not a fit: Patients with known pravastatin hypersensitivity, myasthenia, significant hepatic or renal dysfunction, recent radiotherapy within two years, or only mild/no radiation-associated dysphagia are unlikely to benefit from this treatment.
Why it matters
Potential benefit: If successful, pravastatin could reduce fibrosis-related swallowing impairment and improve nutrition and quality of life for head and neck cancer survivors.
How similar studies have performed: Applying statins for radiation-associated fibrosis is a relatively novel approach with limited clinical trial evidence, though preclinical studies and observational data have suggested possible antifibrotic effects of statins.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Melbourne, Victoria
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Jacqui Frowen, PhD
- Email: Jacqui.Frowen@petermac.org
- Phone: +61 (03) 8559 5220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.