TY - JOUR Y1 - 2026/12// SN - 18794068 ID - uneatlantico17889 VL - 17 TI - Effects of a 12-week multicomponent exercise programme on physical function in older adults with cancer: Study protocol for the ONKO-FRAIL randomised controlled trial JF - Journal of Geriatric Oncology UR - http://doi.org/10.1016/j.jgo.2025.102818 IS - 2 AV - public N2 - Introduction Cancer in older adults is often associated with functional limitations, geriatric syndromes, poor self-rated health, vulnerability, and frailty, and these conditions might worsen treatment-related side effects. Recent guidelines for patients with cancer during and after treatment have documented the beneficial effects of exercise to counteract certain side effects; however, little is known about the role of exercise during cancer treatment in older adults. Materials and Methods This is a multicentre randomised controlled trial in which 200 participants will be allocated to a control group or an intervention group (the sample size has been calculated to detect a clinical difference of 1 point in Short Physical Performance Battery (SPPB) score, assuming an ? error of 0.05, a ? error of 0.20, and a 10 % loss rate). Patients aged ?70 years, diagnosed with any type of solid cancer and candidates for systemic treatment are eligible. Subjects in the intervention group are invited to participate in a 12-week supervised multicomponent exercise programme in addition to receiving usual care. Study assessments are conducted at baseline and three months. The primary outcome measure is physical function as assessed by the SPPB. Secondary outcome measures include comprehensive geriatric assessment scores (including social situation, basic and instrumental activities of daily living, cognitive function, depression, nutritional status, polypharmacy, geriatric syndromes, pain, and emotional distress), anthropometric characteristics, frailty status, physical fitness, physical activity, cognitive function, quality of life, fatigue, and nutritional status. Study assessments also include analysis of inflammatory, endocrine, and nutritional mediators in serum and plasma as potential frailty biomarkers at mRNA and protein levels and multiparametric flow cytometric analysis to measure immunosenescence markers on T and NK cells. Discussion This study seeks to extend our knowledge on exercise interventions during systemic anticancer treatment in patients over 70 years of age. Results from this research will guide the management of older adults during systemic treatment in hospitals seeking to enhance the standard of care. KW - Older adults Cancer Oncogeriatrics Exercise Physical function Frailty Biomarkers Randomised controlled trial A1 - García-García, Julia A1 - Rodriguez-Larrad, Ana A1 - de Rituerto Zeberio, Maren Martinez A1 - Mediavilla, Jenifer Gómez A1 - Vicente, Borja López-San A1 - Artola, Nuria Torrego A1 - Etxetxipia, Izaskun Zeberio A1 - Garmendia, Irati A1 - Alberro, Ainhoa A1 - Otaegui, David A1 - Rabasco, Francisco Borrego A1 - Caffarel, María M. A1 - Vrotsou, Kalliopi A1 - Irazusta, Jon A1 - Arrieta, Haritz A1 - Peláez, Mireia A1 - Belloso, Jon A1 - Basterretxea, Laura ER -