Protocol for the SEHNeCa randomised clinical trial assesing supervised exercise for head and neck Cancer patients

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dc.contributor.authorRodriguez Arietaleanizbeaskoa, Mario
dc.contributor.authorMojas Ereño, Egoitz
dc.contributor.authorArietaleanizbeaskoa, María Soledad
dc.contributor.authorGrandes Odriozola, Gonzalo
dc.contributor.authorRodríguez Sánchez, A.
dc.contributor.authorUrquijo, V.
dc.contributor.authorHernando Alday, I.
dc.contributor.authorDublang Irazabal, Maddalen
dc.contributor.authorAngulo Garay, Garazi
dc.contributor.authorCacicedo, Jon
dc.contributor.authorGil Rey, Erreka
dc.contributor.authorGutiérrez Santamaría, Borja
dc.date.accessioned2025-07-10T09:48:01Z
dc.date.available2025-07-10T09:48:01Z
dc.date.issued2023-03-24
dc.date.updated2025-07-10T09:48:01Z
dc.description.abstractObjectives: 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.en
dc.description.sponsorshipThis study has been funded by Instituto de Salud Carlos III (ISCIII) through the project PI20/00112 and co-funded by the European Unionen
dc.identifier.citationRodriguez-Arietaleanizbeaskoa, Mojas Ereño, Arietaleanizbeaskoa, M., Grandes, Rodríguez Sánchez, Urquijo, Hernando Alday, Dublang, Angulo-Garay, Cacicedo, Arietaleanizbeaskoa, M. S., Grandes, G., Garcia-Alvarez, A., Coca, A., Mendizabal, N., Hoyo, O. d., García-Escobedo, J., Rodríguez Sánchez, Á., Flores Barrenechea, L., et al. (2023). Protocol for the SEHNeCa randomised clinical trial assesing supervised exercise for head and neck Cancer patients. BMC Cancer, 23(1). https://doi.org/10.1186/S12885-023-10718-4
dc.identifier.doi10.1186/S12885-023-10718-4
dc.identifier.eissn1471-2407
dc.identifier.urihttps://hdl.handle.net/20.500.14454/3193
dc.language.isoeng
dc.publisherBioMed Central Ltd
dc.rights© The Author(s) 2023
dc.subject.otherHead and neck cancer
dc.subject.otherLean body mass
dc.subject.otherQuality of life
dc.subject.otherRadiotherapy
dc.subject.otherSarcopenia
dc.subject.otherSupervised physical exercise
dc.titleProtocol for the SEHNeCa randomised clinical trial assesing supervised exercise for head and neck Cancer patientsen
dc.typejournal article
dcterms.accessRightsopen access
oaire.citation.issue1
oaire.citation.titleBMC Cancer
oaire.citation.volume23
oaire.licenseConditionhttps://creativecommons.org/licenses/by/4.0/
oaire.versionVoR
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