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Protocol for the SEHNeCa randomised clinical trial assesing Supervised Exercise for Head and Neck Cancer patients.
Rodriguez-Arietaleanizbeaskoa, M; Mojas Ereño, E; Arietaleanizbeaskoa, M S; Grandes, G; Rodríguez Sánchez, A; Urquijo, V; Hernando Alday, I; Dublang, M; Angulo-Garay, G; Cacicedo, J.
Afiliación
  • Rodriguez-Arietaleanizbeaskoa M; Comprehensive Care Group for Patients With Chronic Diseases, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain. MARIO.RODRIGUEZARIETA@osakidetza.eus.
  • Mojas Ereño E; AFD Salud. Department of Physical Activity and Sport Sciences, Faculty of Education and Sport, University of Deusto, Bizkaia, 48007, Spain.
  • Arietaleanizbeaskoa MS; Comprehensive Care Group for Patients With Chronic Diseases, Biocruces Bizkaia Health Research Institute, Plaza de Cruces 12, 48903, Barakaldo, Bizkaia, Spain.
  • Grandes G; Primary Care Research Unit - Bizkaia, Basque Health Service (Osakidetza), General Directorate, Vitoria-Gasteiz, Spain.
  • Rodríguez Sánchez A; Basurto Radiation Oncology Department, Avenida Montevideo 18, 48013, Bilbao, Bizkaia, Spain.
  • Urquijo V; Cruces Endocrinology Department, Plaza de Cruces S/N, 48903, Barakaldo, Bizkaia, Spain.
  • Hernando Alday I; Basurto Endocrinology Department, Avenida Montevideo 18, 48013, Bilbao, Bizkaia, Spain.
  • Dublang M; Galdakao Endocrinology Department, Barrio Labeaga, 48960, Galdakao, Bizkaia, Spain.
  • Angulo-Garay G; AFD Salud. Department of Physical Activity and Sport Sciences, Faculty of Education and Sport, University of Deusto, Bizkaia, 48007, Spain.
  • Cacicedo J; Department of Radiation Oncology, Group for Radiology and Physical Medicine in Oncology, Cruces University Hospital/Biocruces Bizkaia Health Research Institute, Barakaldo, 48903, Spain.
BMC Cancer ; 23(1): 271, 2023 Mar 24.
Article en En | MEDLINE | ID: mdl-36964485
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.
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Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Terapia por Ejercicio / Neoplasias de Cabeza y Cuello Tipo de estudio: Clinical_trials / Guideline / Prognostic_studies Límite: Humans Idioma: En Revista: BMC Cancer Asunto de la revista: NEOPLASIAS Año: 2023 Tipo del documento: Article País de afiliación: España

Texto completo: 1 Banco de datos: MEDLINE Asunto principal: Terapia por Ejercicio / Neoplasias de Cabeza y Cuello Tipo de estudio: Clinical_trials / Guideline / Prognostic_studies Límite: Humans Idioma: En Revista: BMC Cancer Asunto de la revista: NEOPLASIAS Año: 2023 Tipo del documento: Article País de afiliación: España