Novel Treatment of Radiation Associated Dysphagia With Statins

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