Introduction Malignant Pleural Mesothelioma (MPM) is commonly associated with high symptom burden, cancer cachexia and poor health-related quality of life (HRQOL). Uptake of systemic anti-cancer treatment is low, often due to reduced physical fitness associated with a diagnosis of MPM and advanced age at diagnosis. There is evidence to support exercise therapy in other cancers, including lung cancer, but there is limited evidence for the role of exercise therapy in MPM. EXTRA-Meso feasibility study is a randomised feasibility trial of exercise therapy versus standard care in patients with a diagnosis of MPM.
Methods and Analysis Patients with a diagnosis of mesothelioma, with performance status 0 – 2, clinical frailty score ≤5 will be randomised 1:1 between exercise intervention, where the patient is provided with a personalised exercise and wellbeing programme, after being assessed by a physiotherapist or qualified exercise professional with specific cancer training, or standard care (routine clinical follow-up). The primary objective is to determine whether sufficient numbers of patients, defined as 40 patients over 12 months, can be recruited and randomised to justify a subsequent phase III trial examining the role of exercise therapy in maintaining or improving HRQOL in patients with MPM. Recruitment will take place across 2 UK mesothelioma centres (Glasgow and Manchester). Secondary objectives include assessment of barriers to recruitment and retention, and the safety and tolerability of the intervention and study assessments.
Ethics and Dissemination Protocol approved by West Midlands – South Birmingham Research Ethics Committee (Ref 23/WM/0186). Results will be presented at international scientific meetings and published in peer-reviewed journals.
Trial registration ISRCTN24557328
Competing Interest StatementThe authors have declared no competing interest.
Clinical TrialISRCTN24557328
Funding StatementThis study was funded by Mesothelioma UK (grant award number GR22/02)
Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.
Yes
The details of the IRB/oversight body that provided approval or exemption for the research described are given below:
West Midlands South Birmingham Research Ethics Committee gave ethical approval for this work (Reference 23/WM/0186).
I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.
Yes
I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).
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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.
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Data AvailabilityAll data produced in the present study are available upon reasonable request to the authors
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