Phase 2 study for people with Head and Neck Cancer

Recruiting Phase 2

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 2
Sponsor Peter MacCallum Cancer Centre, Australia
Registry number NCT07217938
Started 5 December 2025 Today 16 October 2026 Estimated completion 1 October 2028

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Peter MacCallum Cancer Centre Melbourne VIC Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 48

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

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

Dates on the record

Started 5 December 2025
Estimated completion 1 October 2028
Registry last updated 4 September 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 4 September 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.