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. 2024 Apr 1;24(1):403.
doi: 10.1186/s12885-024-12172-2.

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

Affiliations

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

Yvette Kriellaars et al. BMC Cancer. .

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.

Keywords: Chemo- or bioradiotherapy; Head and neck cancer; Physical exercise intervention; Physical performance; Trial within cohorts; TwiCs.

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Conflict of interest statement

The authors declare no competing interests.

Figures

Fig. 1
Fig. 1
Flowchart of the recruitment of patients (C/B)RT chemo or bioradiation, M0 measurement before (C/B)RT, M1 measurement after 12 weeks, M2 measurement after 6 months, M3 measurement after 12 months, PEI physical exercise intervention

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References

    1. NKR. Dutch incidence and prevalence head and neck cancer. https://iknl.nl. Accessed 27 Apr 2021.
    1. Chow LQM. Head and Neck Cancer. N Engl J Med. 2020;382:60–72. doi: 10.1056/NEJMra1715715. - DOI - PubMed
    1. Brook I. Early side effects of radiation treatment for head and neck cancer. Cancer/Radiotherapie. 2021;25:507–13. doi: 10.1016/j.canrad.2021.02.001. - DOI - PubMed
    1. Bye A, Sandmael JA, Stene GB, Thorsen L, Balstad TR, Solheim TS, et al. Exercise and nutrition interventions in patients with head and neck cancer during curative treatment: a systematic review and meta-analysis. Nutrients. 2020;12:3233. doi: 10.3390/nu12113233. - DOI - PMC - PubMed
    1. Christensen JF, Simonsen C, Hojman P. Exercise Training in Cancer Control and Treatment. Compr Physiol. 2018;9(1):165–205. doi: 10.1002/cphy.c180016. - DOI - PubMed

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