Novel Treatment of Radiation Associated Dysphagia With Statins
Recruiting
Phase 2
Interventional Study
Radiation-associated Dysphagia
Head &Amp; Neck Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 48 (estimated)
- Sponsor
- Peter MacCallum Cancer Centre, Australia · Other
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About This 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 s…
Trial Locations
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Eligibility Criteria
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 R…
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