TY - JOUR
T1 - The effect of physical exercise during radiotherapy on physical performance in patients with head and neck cancer
T2 - a trial within cohorts study protocol, the vital study
AU - Kriellaars, Yvette
AU - Vermaire, Jorine Ariane
AU - Beugeling, Maaike
AU - Poorter, Robert
AU - Drijvers, Janneke
AU - Speksnijder, Caroline Margina
N1 - Publisher Copyright:
© The Author(s) 2024.
PY - 2024/4/1
Y1 - 2024/4/1
N2 - 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.
AB - 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.
KW - Chemo- or bioradiotherapy
KW - Head and neck cancer
KW - Physical exercise intervention
KW - Physical performance
KW - Trial within cohorts
KW - TwiCs
UR - http://www.scopus.com/inward/record.url?scp=85189549441&partnerID=8YFLogxK
U2 - 10.1186/s12885-024-12172-2
DO - 10.1186/s12885-024-12172-2
M3 - Article
C2 - 38561708
SN - 1471-2407
VL - 24
JO - BMC Cancer
JF - BMC Cancer
IS - 1
M1 - 403
ER -