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NCT Number: NCT07217938

Novel Treatment of Radiation Associated Dysphagia With Statins

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.

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Key information

Conditions

Radiation-associated Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Head &Amp; Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

Location status: Recruiting

Location contact

Dr Jacqui Frowen, PhD

CONTACT

[email protected]

+61 38559 5220

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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)

    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

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

    Time frame: From enrolment to the end of 12 months of pravastatin use

    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.

Secondary outcomes

  1. Acceptability of trial methods and procedures and acceptability of pravastatin

    Time frame: 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)

    Acceptability of trial methods and procedures, and acceptability of pravastatin: Theoretical Framework of Acceptability (TFA) questionnaire total score. The TFA used in this study ranges between 11 - 55 and higher scores represent better acceptability.

  2. Tolerability of pravastatin

    Time frame: From the start of pravastatin therapy until the completion of 12 months of therapy

    Tolerability of pravastatin: percentage of patients who cease pravastatin (patient or clinician choice) due to pravastatin related toxicity using Common Toxicity Criteria for Adverse Events, Version 5.0 (CTCAE v5.0), and the range is 0 to 5, with 5 being the worst outcome

  3. Safety of pravastatin use

    Time frame: From the start of pravastatin therapy until the completion of 12 months of therapy

    Safety of pravastatin use: percentage of patients who experience ≥ Grade 2 toxicity (as per Common Toxicity Criteria for Adverse Events, Version 5.0 [CTCAE v5.0], and the range is 0 to 5, with 5 being the worst outcome)

Other outcomes

  1. Clinician-rated penetration/aspiration

    Time frame: 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 penetration/aspiration: Penetration-Aspiration scale (PAS) score assessed via videofluoroscopy swallow studies (VFSS), the range is 1 to 8, with 8 representing the worst outcome.

  2. Biomechanical swallowing measures

    Time frame: 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)

    Bio-mechanical swallowing measures: using the Computational Analysis of Swallowing Mechanics (CASM) via VFSS, no specific range is available, however ; higher values represent better outcome.

  3. Clinician-rated functional status

    Time frame: 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: Performance Status Scale for Head and Neck Cancer Patients (PSS-HN) subscale scores, the range is between 0 to 100, with higher values representing better outcomes.

  4. Trismus (limitations in mouth opening)

    Time frame: 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)

    Trismus (limitations in mouth opening): Maximal-interincisal opening as measured using the TheraBite® Range-of-Motion scale, the range is between 0 to 70 mm, with higher values representing better outcomes.

  5. Immune-biomarker outcome

    Time frame: At baseline and after 12 months of pravastatin treatment.

    Immune-biomarker outcome: collection of 10 mL edta tube for the immune-biomarker analysis. Specific biomarker selection still under process.

  6. Patient-reported swallowing problem severity

    Time frame: 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)

    Patient-reported swallowing problem severity: Eating Assessment Tool (EAT-10) total score, the range is between 0 to 40, with higher values representing worse outcomes.

  7. Patient-reported swallowing-related QoL:

    Time frame: 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)

    Patient-reported swallowing-related QoL: M.D. Anderson Dysphagia Inventory (MDADI) global score, the range is between 20 to 100, with higher values representing better outcomes.

  8. Patient-reported lymphoedema and fibrosis symptoms and impacts

    Time frame: 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)

    Patient-reported lymphoedema and fibrosis symptoms and impacts: Head and Neck Lymphedema and Fibrosis Symptom Inventory (HN-LEF), the range is between 0 to 165, with higher values representing worse outcomes.

  9. Nutritional outcomes

    Time frame: 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)

    Nutritional outcomes: Weight and feeding tube use (percentage of nutritional requirements taken via gastrostomy tube versus oral intake)

Study contacts

Contact information is provided by the study sponsor or research team.

Jacqui Frowen, PhD

CONTACT

[email protected]

+61 (03) 8559 5220

Sponsors and collaborators

Lead sponsor

Peter MacCallum Cancer Centre, Australia

Other

Registry information

Official study title

TRADstat: Novel Treatment of Radiation Associated Dysphagia With Statins

Acronym: TRADstat

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Oct 20, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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