Pravastatin for long-term swallowing problems after head and neck radiotherapy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.