Presenter(s)
Michael Yan, MD - Princess Margaret Cancer Center, University Health Network, Toronto, ON
M. Yan1, D. Langelier2, E. Chang3, E. Mauti4, B. Hannon5, K. Tsoi6, J. Wunder6, P. Ferguson6, B. A. Millar7, C. Zimmermann5, L. A. Dawson8, B. J. Cummings8, P. Wong9, R. K. Wong10, J. Jones3, and C. J. Tsai8; 1Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Canada, Toronto, ON, Canada, 2University of Calgary, Calgary, AB, Canada, 3Cancer Rehabilitation and Survivorship Program, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada, 4Cancer Rehabilitation Program, University Health Network - Toronto Rehabilitation Institute and Princess Margaret Cancer Centre, Toronto, ON, Canada, 5Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada, 6Division of Orthopaedic Surgery, University Musculoskeletal Oncology Unit, Mount Sinai Hospital, Toronto, ON, Canada, 7Department of Radiation Oncology, University of Toronto, Toronto, ON, Canada, 8Radiation Medicine Program, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada, 9University of Toronto, Toronto, ON, Canada, 10Department of Radiation Oncology, Princess Margaret Cancer Centre, University of Toronto, Toronto, ON, Canada
Purpose/Objective(s): Exercise therapy has demonstrated physical and psychosocial benefits in early-stage cancer patients, but evidence in advanced cancer, particularly in those with bone metastases, remains limited. Due to concerns about skeletal complications, exercise recommendations for this population have been approached with caution. Recent consensus guidelines suggest that supervised exercise may be safe; however, high-quality evidence remains limited, especially in patients with painful bone metastases. Given that radiotherapy is effective in alleviating pain and may promote bone remineralization, we have initiated a phase I trial to assess the safety and feasibility of a supervised exercise program in patients with painful non-spine bone metastases undergoing palliative radiotherapy. Materials/Methods: EXERT-BM (NCT06470503) is a phase I trial evaluating a multi-dimensional rehabilitation program (CaRE-AC) in patients with painful Non-Spine Bone Metastases (NSBM) treated with palliative radiotherapy (RT). Eligible patients must have at least one painful NSBM targeted for conventional or stereotactic body radiotherapy, a KPS of at least 70, and independent ambulatory status with or without ambulatory aids. Patients with untreated neurological compromise, overtly unstable bone metastases, or lack of pain response to RT (residual pain = 5/10 or increased opiate requirements) will be excluded. The trial aims to enroll 20 patients, stratified into weight-bearing and non-weight-bearing groups, with at least five in each. Eligibility will be assessed in a two-step process, with initial screening before RT and confirmation one to four weeks post-treatment based on pain response. Participants will undergo multidisciplinary evaluation, including physical medicine, palliative care, and orthopedic oncology assessment, before being enrolled in CaRE-AC. This program consists of weekly group exercise sessions and an educational component to address symptom management, nutrition, and mood. Follow-up visits will occur at one, three-, and six-months post-intervention. The primary endpoint encompasses both safety and feasibility. Safety is determined by the absence of any skeletal-related events or any serious adverse events or grade =3 toxicity related to the intervention. Feasibility is assessed based on the successful enrollment of 20 patients, an 80% intervention completion rate, 80% participant satisfaction, and 60% retention at one-month post-intervention. Secondary endpoints include the incidence of treatment-related toxicity, pain response at the index lesion, health-related quality of life measured by EORTC QLQ-C30 and BM22, functional outcomes assessed through the 30-second sit-to-stand test, six-minute walk test, and Time Up and Go test, and self-reported physical activity using the modified Godin questionnaire. Results: Pending. Conclusion: Patient enrollment is ongoing, with full accrual anticipated by the end of 2025.
