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Effect of a multimodal intervention in breast Cancer patients undergoing neoadjuvant therapy: A study protocol of the multimodal project.
Muñoz-Lerma, Amelia; Sánchez-Sánchez, Rocío; Ruiz-Vozmediano, Julia; Yebras Cano, Tábatha; González-Jiménez, Antonio; Jurado-Fasoli, Lucas.
Afiliación
  • Muñoz-Lerma A; Servicio de Oncología Médica, Hospital Universitario Virgen de las Nieves, 18004 Granada, Spain. Electronic address: ameliamlerma@correo.ugr.es.
  • Sánchez-Sánchez R; Servicio de Medicina Nuclear, Hospital Universitario Virgen de las Nieves, 18004 Granada, Spain; Instituto de Investigación Biosanitaria ibs.GRANADA, 18012 Granada, Spain.
  • Ruiz-Vozmediano J; Servicio de Oncología Médica, Hospital Universitario Virgen de las Nieves, 18004 Granada, Spain; Instituto de Investigación Biosanitaria ibs.GRANADA, 18012 Granada, Spain; Centro de Oncología Integrativa Onconature, 18418 Granada, Spain.
  • Yebras Cano T; Centro Evital Clinic de Fisioterapia y Rehabilitación Online, Spain.
  • González-Jiménez A; Servicio de Oncología Médica, Hospital Universitario de Jaén, 23007 Jaén, Spain.
  • Jurado-Fasoli L; Department of Physiology, Faculty of Medicine, University of Granada, 18071 Granada, Andalucía, Spain; Department of Physical Education and Sports, Faculty of Sports Science, Sport and Health University Research Institute (iMUDS), University of Granada, Carretera de Alfacar s/n, 18071 Granada, Spain
Contemp Clin Trials ; 143: 107598, 2024 Aug.
Article en En | MEDLINE | ID: mdl-38838986
ABSTRACT
BACKGROUND AND

AIMS:

To determine the effect of a multimodal intervention (nutritional behavior change and physical exercise) on quality of life, chemotherapy response rate and tolerance, histopathological level of the tumor, body composition, and biochemical parameters, in patients diagnosed with breast cancer during neoadjuvant chemotherapy treatment, and to compare them with the control group.

METHODS:

Anticipated 80 patients diagnosed with breast cancer aged 18-70 years will be recruited for this randomized, unblinded clinical trial based on a nutritional behavior change and physical exercise in patients during the approximately 6 months in which the patient receives neoadjuvant treatment. Participants will be randomly allocated (11) to one of two groups (intervention or control). Primary and secondary outcomes will be assessed before the beginning and after the neoadjuvant treatment (before surgery). The primary outcome is quality of life, whereas secondary outcomes include chemotherapy response rate and tolerance, histopathological level of the tumor and body composition (i.e., visceral adipose tissue activity, bone, lean and fat masses). We will analyze blood parameters (i.e., biochemical, inflammatory, and tumor markers) as exploratory outcomes.

CONCLUSION:

This study will address the influence of a practical and viable multimodal intervention (i.e., nutritional behavior change and physical exercise) on breast cancer patients undergoing neoadjuvant chemotherapy. Given the practical viability of the intervention in real-world settings, our study holds promise for significant scientific and clinical implications.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calidad de Vida / Composición Corporal / Neoplasias de la Mama / Terapia Neoadyuvante Límite: Adolescent / Adult / Aged / Female / Humans / Middle aged Idioma: En Revista: Contemp Clin Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Calidad de Vida / Composición Corporal / Neoplasias de la Mama / Terapia Neoadyuvante Límite: Adolescent / Adult / Aged / Female / Humans / Middle aged Idioma: En Revista: Contemp Clin Trials Asunto de la revista: MEDICINA / TERAPEUTICA Año: 2024 Tipo del documento: Article Pais de publicación: Estados Unidos