Novel Treatment of Radiation Associated Dysphagia With Statins

TRADstat: Novel Treatment of Radiation Associated Dysphagia With Statins

Novel Treatment of Radiation Associated Dysphagia With Statins (NCT07217938) is a Phase 2 interventional studying Radiation-associated Dysphagia and Head &Amp; Neck Cancer, sponsored by Peter MacCallum Cancer Centre, Australia. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

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 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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Radiation-associated Dysphagia and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 48 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Patient has provided written willing to sign a consent form 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) Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

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 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 Criteria: 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

Treatments Being Tested

DRUG

Pravastatin 40 Mg Oral Tablet

This trial will incorporate Pravastatin 40 mg as an off-label use for the treatment of radiation-associated dysphagia.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07217938), the sponsor (Peter MacCallum Cancer Centre, Australia), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07217938 clinical trial studying?

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 p… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07217938?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07217938?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07217938. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07217938. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.