BMJ open · 2026
Treatment of Radiation-Associated Dysphagia with Statins (TRADstat): protocol for a prospective, single-site, single-arm pilot trial.
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Frowen Jacqui, Rischin Danny, Porceddu Sandro, Alexander Marliese, Dyer Mitchell, Ahmad Haris, Fua Tsien, Di Iulio Juliana, Pizzolla Angela, Gough Karla
Аннотация
INTRODUCTION: Radiation-associated dysphagia (RAD) is one of the most common and profound side effects of radiotherapy for head and neck cancer (HNC), but there is currently no effective treatment for persistent or late-onset RAD. Pravastatin has shown potential in reversing established fibrosis through modulation of the connective tissue growth factor signalling pathway and decreasing pro-inflammatory and profibrotic cytokines. Treatment of RAD with statins (TRADstat) is a pilot trial designed to evaluate the feasibility (primary outcome), efficacy potential, acceptability and safety of a 12-month trial of pravastatin as an antifibrotic agent for managing late-RAD.
METHODS AND ANALYSIS: 48 patients who are at least 2 years post (chemo)radiotherapy for HNC of the oropharynx, nasopharynx, hypopharynx or larynx and have at least moderate dysphagia will be recruited to this single-site, single-arm pilot trial. Participants will receive pravastatin 40 mg/day continuously for up to 12 months. Primary feasibility outcome data (recruitment, trial retention and medication adherence) will be summarised as a proportion with 95% CI. These will be judged against pre-specified criteria for trial progression and analysed using a one-sided exact binomial test. All remaining data will be analysed descriptively.
ETHICS AND DISSEMINATION: The trial protocol and informed consent documents have been reviewed and approved by the Peter MacCallum Cancer Centre Human Research Ethics Committee (HREC/121555/PMCC, protocol version 1.3, 11 May 2026). Study findings will be disseminated through peer-reviewed publications, at national and international conferences and at key stakeholder forums.
TRIAL REGISTRATION NUMBER: clinicaltrials.gov NCT07217938
METHODS AND ANALYSIS: 48 patients who are at least 2 years post (chemo)radiotherapy for HNC of the oropharynx, nasopharynx, hypopharynx or larynx and have at least moderate dysphagia will be recruited to this single-site, single-arm pilot trial. Participants will receive pravastatin 40 mg/day continuously for up to 12 months. Primary feasibility outcome data (recruitment, trial retention and medication adherence) will be summarised as a proportion with 95% CI. These will be judged against pre-specified criteria for trial progression and analysed using a one-sided exact binomial test. All remaining data will be analysed descriptively.
ETHICS AND DISSEMINATION: The trial protocol and informed consent documents have been reviewed and approved by the Peter MacCallum Cancer Centre Human Research Ethics Committee (HREC/121555/PMCC, protocol version 1.3, 11 May 2026). Study findings will be disseminated through peer-reviewed publications, at national and international conferences and at key stakeholder forums.
TRIAL REGISTRATION NUMBER: clinicaltrials.gov NCT07217938