The effect of physical exercise during radiotherapy on physical functioning in patients with head and neck cancer: a trial within cohorts, the VITAL study

Background: During the last ten years, twelve studies are published investigating physical exercise interventions (PEIs) for patients with head and neck cancer (HNC) during or after radiotherapy (RT), chemoradiation (CRT) or bioradiation (BRT). The overall conclusion is clear, PEIs for patients with HNC are safe and feasible. PEIs during or after RT, CRT or BRT ((C/B)RT) may maintain or improve physical function and quality of life (QoL). It is, however, necessary to do more research to underpin these effects. Besides, a cost-effectiveness analysis is missing. The aim of this study is to determine and compare physical performance, muscle strength, fatigue, QoL, body composition, nutritional status, physical activity, treatment tolerability of (C/B)RT, and healthcare related costs in patients with HNC with and without a 10 week exercise intervention during (C/B)RT. Methods This study based on a trial within cohorts (TwiCs) design will contain a prospective cohort with 112 patients. Half of the 112 patients will randomly be invited for an experimental 10 week PEI. Measurements are at baseline (M0), after 12 weeks (M1), 6 months (M2) and 12 months (M3). Statistical analyses will be performed for intention-to-treat and instrumental variable analysis using SPSS. Discussion This study is the first randomized study investigating the effect of PEI in a Dutch HNC population and it is the first study investigating the cost-effectiveness of PEI in HNC patients. A TwiCs design will be used. However, with this design, effect estimation can be more challenging. Trial Registration protocol is registered at clinicaltrials.gov with number NCT05988060.