Novel Treatment of Radiation Associated Dysphagia With Statins

NCT07217938 | Recruiting Phase 2

• 1 other identifier: 121555
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiation-associated Dysphagia; Head &Amp; Neck Cancer

Keywords

Radiation-associated dysphagia; Dysphagia; Head & neck cancer; Pravastatin

Outcome Measures

Primary Outcomes (2)

• Feasibility of a 12 month trial investigating the use of pravastatin to treat radiation-associated dysphagia

  Percentage of eligible patients who consent to recruitment and percentage of recruited (registered) patients who remain on pravastatin for 12 months and complete the 6-month follow-up assessment

  From the start of pravastatin therapy to 6 months of follow up after the completion of 12 months of pravastatin therapy (total estimated time duration 18 months)

• Preliminary evidence of efficacy of the pravastatin to treat radiation-associated dysphagia

  A Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) grade decrease of at least 1-point after 12 months of pravastatin from registration. The DIGEST scale ranges between 0 to 4, with 4 being the worst outcome.

  From enrolment to the end of 12 months of pravastatin use

Secondary Outcomes (3)

• Acceptability of trial methods and procedures and acceptability of pravastatin

  From the start of pravastatin therapy to 6 months of follow up after the completion of 12 months of pravastatin therapy (total estimated time duration 18 months)

• Tolerability of pravastatin

  From the start of pravastatin therapy until the completion of 12 months of therapy

• Safety of pravastatin use

  From the start of pravastatin therapy until the completion of 12 months of therapy

Other Outcomes (9)

• Clinician-rated penetration/aspiration

  From the start of pravastatin therapy to 6 months of follow up after the completion of 12 months of pravastatin therapy (total estimated time duration 18 months)

• Biomechanical swallowing measures

  From the start of pravastatin therapy to 6 months of follow up after the completion of 12 months of pravastatin therapy (total estimated time duration 18 months)

• Clinician-rated functional status

  From the start of pravastatin therapy to 6 months of follow up after the completion of 12 months of pravastatin therapy (total estimated time duration 18 months)

Study Arms (1)

Single arm study

EXPERIMENTAL

Single arm study

Drug: Pravastatin 40 Mg Oral Tablet

Interventions

Pravastatin 40 Mg Oral Tablet DRUG

This trial will incorporate Pravastatin 40 mg as an off-label use for the treatment of radiation-associated dysphagia.

Single arm study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has provided written informed consent using the TRADstat PICF
• Patients aged 18 years or older at screening
• Received curative intent (chemo)radiotherapy to the nasopharynx, oropharynx, hypopharynx or larynx at least 2 years prior to screening
• 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
• Adequate kidney function defined as estimated glomerular filtration rate (eGFR) ≥ 40 ml/min
• 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
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2 (Appendix 1)

You may not qualify if:

• Known hypersensitivity to pravastatin and/or any excipients
• Diagnosis of myasthenia (muscle weakness)
• History of head or neck surgery, other than excisional biopsy or post treatment neck dissection
• Known active malignancy
• Currently taking statin medication
• Currently taking prohibited medicines (long-term steroids or drugs listed under Section 8.4)
• History of severe heart failure; a history of muscle toxicity during previous treatments with fibrates or statins; a history of hereditary muscle diseases
• Known medical condition(s) that may impact swallowing function (e.g., stroke, neurological conditions, tracheostomy)
• Pregnant or breastfeeding

Sponsors & Collaborators

• Peter MacCallum Cancer Centre, Australia: lead

Study Sites (1)

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

RECRUITING

Related Publications (1)

• Bourgier C, Auperin A, Rivera S, Boisselier P, Petit B, Lang P, Lassau N, Taourel P, Tetreau R, Azria D, Bourhis J, Deutsch E, Vozenin MC. Pravastatin Reverses Established Radiation-Induced Cutaneous and Subcutaneous Fibrosis in Patients With Head and Neck Cancer: Results of the Biology-Driven Phase 2 Clinical Trial Pravacur. Int J Radiat Oncol Biol Phys. 2019 Jun 1;104(2):365-373. doi: 10.1016/j.ijrobp.2019.02.024. Epub 2019 Feb 15.

  PMID: 30776452 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Deglutition Disorders

Interventions

Pravastatin; Tablets

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Central Study Contacts

Jacqui Frowen, PhD

CONTACT

+61 (03) 8559 5220; Jacqui.Frowen@petermac.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: October 20, 2025
• Study Start: December 5, 2025
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)