RecruitingPhase IIEN originalHead and neck cancer

Novel Treatment of Radiation Associated Dysphagia With Statins

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • •Wiek co najmniej 18 lat
  • •Otrzymanie radioterapii raka głowy i szyi (gardła, krtani) co najmniej 2 lata temu
  • •Poważne problemy z połykaniem po radioterapii, potwierdzone badaniem przełyku
  • •Prawidłowa funkcja nerek (wynik eGFR co najmniej 40)
  • •Prawidłowa funkcja wątroby
  • •Ogólnie dobre samopoczucie umożliwiające uczestnictwo w badaniu
  • •Podpisana zgoda na uczestnictwo w badaniu

✗ Disqualifies

  • •Uczulenie na prawastatynę
  • •Historia miopatii (słabości mięśni)
  • •Poprzednia chirurgia głowy i szyi (poza biopsją lub usunięciem węzłów chłonnych)
  • •Aktywny nowotwór
  • •Obecnie przyjmowanie innych statyn
  • •Historia poważnej niedomykalności serca lub toksyczności mięśni ze statyn
  • •Ciąża lub karmienie piersią
  • •Choroby wpływające na połykanie (udar, schorzenia neurologiczne)

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
September 4, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (1)

Peter MacCallum Cancer Centre

Melbourne, Australia

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 9/5/2026.

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