MULTIMODAL INTERVENTION WITH NUTRITIONAL SUPPLEMENTATION AND PHYSICAL EXERCISE IN WOMEN WITH BREAST CANCER: EFFECTS ON MUSCLE PERFORMANCE AND QUALITY OF LIFE

Resumo

Breast cancer is the most prevalent malignant neoplasm among women worldwide and represents a major public health concern due to its high incidence, mortality, and functional impact. Patients undergoing chemotherapy frequently experience impaired nutritional status, sarcopenia, reduced muscle performance, and decreased quality of life. Recent evidence suggests that nutritional interventions combined with physical exercise may contribut e to the preservation of lean body mass and functional capacity in oncological patients. However, gaps remain regarding the effects of hyperproteic nutritional supplementation enriched with vitamins and minerals in women with breast cancer during chemother apy. It is hypothesized that this multimodal intervention may improve muscle mass preservation, functional performance, and quality of life compared with placebo and healthy control groups.This study aims to evaluate the effects of a hyperproteic and normocaloric nutritional intervention enriched with vitamins and minerals, combined with a physical exercise program, on body composition, muscle performance, and quality of life in women with breast cancer undergoing chemotherapy, compared with healthy control s. This study is a randomized, double-blind, placebo-controlled clinical trial conducted in an outpatient oncology setting. Patients aged 18 to 70 years will be recruited from Oncology UNIMAR Hospital (with a confirmed diagnosis of breast cancer, preserved oral intake capacity, and scheduled to initiate chemotherapy treatment) and from UNIMAR Participants will be randomly assigned into seven groups according to clinical condition, physical exercise participation, and nutritional supplementation, as follows: healthy controls (H); healthy supplemented (H+S); healthy exercising (H+E); healthy exercising and supplemented (H+E+S); breast cancer patients (BC); breast cancer supplemented (BC+S); and breast cancer exercising (BC+E). Sample size calculation has not y et been performed and will be determined prior to data collection considering 80% statistical power and a 5% significance level.The intervention groups will receive daily a hyperproteic ice cream enriched with vitamins and minerals developed by the researc h group. The placebo groups will receive an isocaloric ice cream with similar sensory characteristics but without protein or micronutrient enrichment to ensure blinding. Dietary prescriptions will be individualized to maintain normocaloric intake throughou t follow -up. The exercise protocol will follow the American College of Sports Medicine guidelines. The primary outcome will be preservation of muscle mass. Secondary outcomes will include muscle performance, functionality, nutritional status, sarcopenia risk, and quality of life. Assessments will include EORTC QLQ -C30, EORTC QLQ-BR23, SARC -F, IPAQ, MUST, SPPB, handgrip dynamometry, DEXA, and computed tomography with L3 analysis. Computed tomography will be performed exclusively in women with breast cancer u sing imaging examinations already included in routine oncological care, avoiding additional radiation exposure for research purposes. Healthy controls will undergo only noninvasive assessments. It is expected that the multimodal intervention will preserve muscle mass, improve functionality, and reduce nutritional impairments associated with chemotherapy, contributing to better quality of life in women with breast cancer