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

Abstract

Abstract Background: 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 cancer patients 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. Methods: This is a multicentre randomised controlled trial in which 200 participants will be allocated to a control group or an intervention group. 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 3 months. The primary outcome measure is physical function as assessed by the Short Physical Performance Battery. Secondary outcome measures include comprehensive geriatric assessment scores, 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. This research has been approved by the Research Ethics Committee of the Basque Country. 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. Trial registration: ClinicalTrials.gov Identifier: NCT05131113, November 11, 2021.