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. 2023 Mar 24;23(1):271.
doi: 10.1186/s12885-023-10718-4.

Protocol for the SEHNeCa randomised clinical trial assesing Supervised Exercise for Head and Neck Cancer patients

M Rodriguez-Arietaleanizbeaskoa  1 , E Mojas Ereño  2 , M S Arietaleanizbeaskoa  3 , G Grandes  4 , A Rodríguez Sánchez  5 , V Urquijo  6 , I Hernando Alday  7 , M Dublang  8 , G Angulo-Garay  2 , J Cacicedo  9 ; SEHNeCa group
Collaborators, Affiliations

Protocol for the SEHNeCa randomised clinical trial assesing Supervised Exercise for Head and Neck Cancer patients

M Rodriguez-Arietaleanizbeaskoa et al. BMC Cancer. .

Abstract

Objectives: To evaluate the effectiveness of an innovative supervised exercise programme to mitigate the loss of lean body mass, functional capacity and quality of life in people with head and neck cancer, as well as to identify the optimal moment to apply it, before or after radiotherapy treatment, compared with the prescription of a physical activity plan carried out autonomously.

Methods: Patients with squamous cell carcinoma of the head and neck (n = 144), treated with radiotherapy, will be randomly assigned to one of 3 comparison groups: pre-radiotherapy supervised exercise, post-radiotherapy supervised exercise and autonomous exercise, stratifying by human papillomavirus infection and previous surgery. The exercise programme will be carried out in 36 sessions over 12 weeks, combining moderate and high intensity strength and aerobic exercises. The main outcome variable is the change in lean body mass at 6 months measured by bioimpedance, while secondary variables are functional capacity, symptoms, quality of life and adverse effects. Longitudinal generalised mixed models will be used for the analyses of the repeated measurements at 3, 6, and 12 months after baseline.

Conclusions: The pilot study supports the feasibility and safety of the project. However, as the programme progressed, attendance at the sessions decreased. Strategies will be necessary for increasing attendance, as well as involving the patient in their recovery and other incentives. Follow-up after treatment to assess acute/late toxicity will enable us to know the response to both the exercise programme and its adherence.

Trial registration: NCT04658706 Date and version identifier: March 1, 2023. Version 1.1.

Keywords: Head and neck cancer; Lean body mass; Quality of life; Radiotherapy; Sarcopenia; Supervised physical exercise.

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Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Flow diagram. PVS Prescribe Vida Saludable
Fig. 2
Fig. 2
SEHNeCa exercise programme. M1: Low to moderate intensity; M2: moderate intensity; M3: intensive moderate intensity; 1RM: 1 maximum repetition
See this image and copyright information in PMC

References

    1. Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, et al. Global cancer statistics 2020: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA: Cancer J Clin. 2021;71(3):209–49. - PubMed
    1. SEOM. Las cifras del cáncer en España 2022 [Internet]. 2022. Available from: https://seom.org/images/LAS_CIFRAS_DEL_CANCER_EN_ESPANA_2022.pdf
    1. Schmitz KH, Courneya KS, Matthews C, Demark-Wahnefried W, Galvão DA, Pinto BM, et al. American college of sports medicine roundtable on exercise guidelines for cancer survivors. Med Sci Sports Exerc. 2010;42(7):1409–1426. doi: 10.1249/MSS.0b013e3181e0c112. - DOI - PubMed
    1. Langius JAE, Bakker S, Rietveld DHF, Kruizenga HM, Langendijk JA, Weijs PJM, et al. Critical weight loss is a major prognostic indicator for disease-specific survival in patients with head and neck cancer receiving radiotherapy. Br J Cancer. 2013;109(5):1093–9. doi: 10.1038/bjc.2013.458. - DOI - PMC - PubMed
    1. Datema FR, Ferrier MB, de Baatenburg Jong RJ. Impact of severe malnutrition on short-term mortality and overall survival in head and neck cancer. Oral Oncol. 2011;47(9):910–4. doi: 10.1016/j.oraloncology.2011.06.510. - DOI - PubMed

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