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New treatment option for Radiation-associated Dysphagia
Official title Novel Treatment of Radiation Associated Dysphagia With Statins
ClinicalTrials.gov ID: NCT07217938
What this study is testing
What is Pravastatin 40 Mg Oral Tablet?
Pravastatin 40 Mg Oral Tablet is an investigational medicine, given as an once-daily, being studied as a potential treatment for radiation-associated dysphagia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 12 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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
You likely can't join 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)
See the full eligibility 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)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.