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Open Access 01-12-2024 | Radiotherapy | Study Protocol

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

Authors: Yvette Kriellaars, Jorine Ariane Vermaire, Maaike Beugeling, Robert Poorter, Janneke Drijvers, Caroline Margina Speksnijder

Published in: BMC Cancer | Issue 1/2024

Abstract

Background

During the last decade, twelve studies have been published investigating physical exercise interventions (PEIs) in patients with head and neck cancer (HNC) during radiotherapy (RT), chemoradiation (CRT) or bioradiation (BRT). These studies showed that these PEIs are safe and feasible. However, only two of these studies were randomised clinical trials (RCTs) with a satisfying sample size. Thereby, there is no cost-effectiveness study related to a PEI during RT, CRT or BRT ((C/B)RT) for patients with HNC. Therefore, the aim of this study is to investigate and compare physical performance, muscle strength, fatigue, quality of life (QoL), body mass index (BMI), nutritional status, physical activity, treatment tolerability, and health care related costs in patients with HNC with and without a 10 week PEI during (C/B)RT.

Methods

This study, based on a trial within cohorts (TwiCs) design, will contain a prospective cohort of at least 112 patients. Fifty-six patients will randomly be invited for an experimental 10 week PEI. This PEI consists of both resistance and endurance exercises to optimize physical performance, muscle strength, fatigue, QoL, BMI, nutritional status, physical activity, and treatment tolerability of (C/B)RT. Measurements are at baseline, after 12 weeks, 6 months, and at 12 months. Statistical analyses will be performed for intention-to-treat and instrumental variable analysis.

Discussion

This study seeks to investigate physical, QoL, and economic implications of a PEI. With a substantial sample size, this study attempts to strengthen and expand knowledge in HNC care upon PEI during (C/B)RT. In conclusion, this study is dedicated to provide additional evidence for PEI in patients with HNC during (C/B)RT.

Trial registration

protocol was registered at clinicaltrials.gov with number NCT05988060 on 3 August 2023.

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Title: The effect of physical exercise during radiotherapy on physical performance in patients with head and neck cancer: a trial within cohorts study protocol, the vital study
Authors: Yvette Kriellaars
Jorine Ariane Vermaire
Maaike Beugeling
Robert Poorter
Janneke Drijvers
Caroline Margina Speksnijder
Publication date: 01-12-2024
Publisher: BioMed Central
Keywords: Radiotherapy
Fatigue
Published in: BMC Cancer / Issue 1/2024
Electronic ISSN: 1471-2407
DOI: https://doi.org/10.1186/s12885-024-12172-2

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Abstract

Background

Methods

Discussion

Trial registration

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