Novel Treatment of Radiation Associated Dysphagia With Statins (TRADstat)

Peter MacCallum Cancer Centre, Australia

Status and phase: Not yet enrolling; Phase 2

Conditions: Radiation-associated Dysphagia; Head &Amp; Neck Cancer

Treatments: Drug: Pravastatin 40 Mg Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT07217938

121555

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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48 participants in 1 patient group

Single arm study

Experimental group

Description:

Single arm study

Treatment:

Drug: Pravastatin 40 Mg Oral Tablet