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RecruitingLast updated: 27 May 2026

TRADstat: Testing whether taking the cholesterol medicine pravastatin can help improving swallowing problems (dysphagia) caused by past radiation fibrosis in people treated for head and neck cancerTRADstat: Novel Treatment of Radiation Associated Dysphagia With Statins

Trial purpose

Medical clipboardSide effect and wellbeing

Tumor type

Head and Neck Cancers Head and Neck

Age

People18+

Trial acronym

TRADstat

Clinical summary

Summary

This study is looking at whether a medicine used for cholesterol management (called pravastatin) can help improve swallowing problems (also known as dysphagia) in people who have previously had radiation therapy for head and neck cancer.

Pravastatin is already approved for use in Australia for cholesterol management, and researchers want to determine if taking it can make swallowing easier and improve quality of life for people with ongoing swallowing problems after cancer treatment.

The study will recruit 48 people over a period of approximately 6 months. 

Who is this study for?
People may be invited to take part if the are referred by their radiation oncologist or speech pathologist because they have swallowing problems caused by radiation therapy.

You may be eligible if you have received (chemo)radiotherapy to the nasopharynx, oropharynx, hypopharynx or larynx at least 2 years prior to joining the study.

You cannot take part in this study if you have had surgery for your head and neck cancer, except if the surgery was only a neck dissection.
 
Study details
Participants will take pravastatin oral tablets (40mg) once a day for up to 12 months. Swallowing will be assessed before starting medication, during the treatment period, and after finishing treatment.

Conditions

This trial is treating people with who have received radiation therapy for a head and neck cancer and are experiencing swallowing problems

Eligibility

Inclusion

  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

  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

Inclusion

  • You have had a certain type of treatment or surgical procedure.
  • You have the type of cancer, symptoms, or health risks that this clinical trial is focused on.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Peter MacCallum Cancer Centre, Australia

Scientific Title

TRADstat: Novel Treatment of Radiation Associated Dysphagia With Statins

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