Radiation-associated DysphagiaPhase 2TRADstatNCT07217938
Novel Treatment of Radiation Associated Dysphagia With Statins
A Phase 2 study testing Pravastatin 40 Mg Oral Tablet in people with Radiation-associated Dysphagia and Head &Amp; Neck Cancer, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation-associated Dysphagia, Head &Amp; Neck Cancer
- What is being tested?
- Pravastatin 40 Mg Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- 5 Dec 2025to 1 Oct 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Australia1 site, 1 recruiting
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
Dr Jacqui Frowen, PhD, +61 38559 5220, jacqui.frowen@petermac.org
About this study
Official title: TRADstat: Novel Treatment of Radiation Associated Dysphagia With Statins
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.
- Being tested
- Pravastatin 40 Mg Oral Tablet
- Keywords
- Radiation-associated dysphagia, Dysphagia, Head & neck cancer, Pravastatin
- Medical subject headings
- Head and Neck Neoplasms, Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pravastatin 40 Mg Oral TabletDrug
This trial will incorporate Pravastatin 40 mg as an off-label use for the treatment of radiation-associated dysphagia.
| Study group | Role | What they receive |
|---|---|---|
| Single arm study | Experimental | Single arm study Receives: Drug: Pravastatin 40 Mg Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a 12 month trial investigating the use of pravastatin to treat radiation-associated dysphagia
Percentage of eligible patients who consent to recruitment and percentage of recruited (registered) patients who remain on pravastatin for 12 months and complete the 6-month follow-up assessment
Measured: From the start of pravastatin therapy to 6 months of follow up after the completion of 12 months of pravastatin therapy (total estimated time duration 18 months)
Preliminary evidence of efficacy of the pravastatin to treat radiation-associated dysphagia
A Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) grade decrease of at least 1-point after 12 months of pravastatin from registration. The DIGEST scale ranges between 0 to 4, with 4 being the worst outcome.
Measured: From enrolment to the end of 12 months of pravastatin use
Secondary outcomes (3)
Acceptability of trial methods and procedures and acceptability of pravastatin
Acceptability of trial methods and procedures, and acceptability of pravastatin: Theoretical Framework of Acceptability (TFA) questionnaire total score. The TFA used in this study ranges between 11 - 55 and higher scores represent better acceptability.
Measured: From the start of pravastatin therapy to 6 months of follow up after the completion of 12 months of pravastatin therapy (total estimated time duration 18 months)
Tolerability of pravastatin
Tolerability of pravastatin: percentage of patients who cease pravastatin (patient or clinician choice) due to pravastatin related toxicity using Common Toxicity Criteria for Adverse Events, Version 5.0 (CTCAE v5.0), and the range is 0 to 5, with 5 being the worst outcome
Measured: From the start of pravastatin therapy until the completion of 12 months of therapy
Safety of pravastatin use
Safety of pravastatin use: percentage of patients who experience ≥ Grade 2 toxicity (as per Common Toxicity Criteria for Adverse Events, Version 5.0 [CTCAE v5.0], and the range is 0 to 5, with 5 being the worst outcome)
Measured: From the start of pravastatin therapy until the completion of 12 months of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start5 Dec 2025
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiation-associated DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter MacCallum Cancer Centre, Australia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217938
- Sponsor's protocol ID
- 121555
- Acronym
- TRADstat
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual de-identified participant data including imaging and research bloods data, may be made available upon reasonable request, subject to institutional approvals and applicable privacy and ethical requirements.
Publications
Bourgier C, Auperin A, Rivera S, Boisselier P, Petit B, Lang P, Lassau N, Taourel P, Tetreau R, Azria D, Bourhis J, Deutsch E, Vozenin MC. Pravastatin Reverses Established Radiation-Induced Cutaneous and Subcutaneous Fibrosis in Patients With Head and Neck Cancer: Results of the Biology-Driven Phase 2 Clinical Trial Pravacur. Int J Radiat Oncol Biol Phys. 2019 Jun 1;104(2):365-373. doi: 10.1016/j.ijrobp.2019.02.024. Epub 2019 Feb 15.
PubMed 30776452
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRADstat: Novel Treatment of Radiation Associated Dysphagia With Statins
- ClinicalTrials.gov ID
- NCT07217938
- Acronym / sponsor ID
- TRADstat / 121555
- Keywords
- Radiation-associated dysphagia, Dysphagia, Head & neck cancer, Pravastatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Peter MacCallum Cancer Centre, AustraliaUniversity, hospital or other
- Study start
- 5 Dec 2025 (actual)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Oct 2028 (estimated)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm study | Experimental | Drug: Pravastatin 40 Mg Oral TabletSingle arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pravastatin 40 Mg Oral TabletThis trial will incorporate Pravastatin 40 mg as an off-label use for the treatment of radiation-associated dysphagia. | Drug | Single arm study |
Primary outcome
Feasibility of a 12 month trial investigating the use of pravastatin to treat radiation-associated dysphagia
Time frame: From the start of pravastatin therapy to 6 months of follow up after the completion of 12 months of pravastatin therapy (total estimated time duration 18 months)
Percentage of eligible patients who consent to recruitment and percentage of recruited (registered) patients who remain on pravastatin for 12 months and complete the 6-month follow-up assessment
Preliminary evidence of efficacy of the pravastatin to treat radiation-associated dysphagia
Time frame: From enrolment to the end of 12 months of pravastatin use
A Dynamic Imaging Grade of Swallowing Toxicity (DIGEST) grade decrease of at least 1-point after 12 months of pravastatin from registration. The DIGEST scale ranges between 0 to 4, with 4 being the worst outcome.
3 secondary outcomes
Acceptability of trial methods and procedures and acceptability of pravastatin
Time frame: From the start of pravastatin therapy to 6 months of follow up after the completion of 12 months of pravastatin therapy (total estimated time duration 18 months)
Tolerability of pravastatin
Time frame: From the start of pravastatin therapy until the completion of 12 months of therapy
Safety of pravastatin use
Time frame: From the start of pravastatin therapy until the completion of 12 months of therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Background: PubMed 30776452Bourgier C, Auperin A, Rivera S, Boisselier P, Petit B, Lang P, Lassau N, Taourel P, Tetreau R, Azria D, Bourhis J, Deutsch E, Vozenin MC. Pravastatin Reverses Established Radiation-Induced Cutaneous and Subcutaneous Fibrosis in Patients With Head and Neck Cancer: Results of the Biology-Driven Phase 2 Clinical Trial Pravacur. Int J Radiat Oncol Biol Phys. 2019 Jun 1;104(2):365-373. doi: 10.1016/j.ijrobp.2019.02.024. Epub 2019 Feb 15.
- Individual participant dataSharing planned: Yes. Individual de-identified participant data including imaging and research bloods data, may be made available upon reasonable request, subject to institutional approvals and applicable privacy and ethical requirements.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pravastatin 40 Mg Oral Tablet in people with Radiation-associated Dysphagia and Head &Amp; Neck Cancer, run by Peter MacCallum Cancer Centre, Australia at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jacqui Frowen, PhD (+61 (03) 8559 5220, Jacqui.Frowen@petermac.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a 12 month trial investigating the use of pravastatin to treat radiation-associated dysphagia (time frame: From the start of pravastatin therapy to 6 months of follow up after the completion of 12 months of pravastatin therapy (total estimated time duration 18 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07217938, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.