EXercise TheRApy in Mesothelioma feasibility study (EXTRA-Meso Feasibility). Protocol of a randomised feasibility study

IntroductionMalignant 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 AnalysisPatients 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 DisseminationProtocol 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 registrationISRCTN24557328