protocolSection identificationModule nctId: NCT06309290, orgStudyIdInfo id: FAPESP-UFRO, briefTitle: Prehabilitation With Resistance-exercise Training for Breast Cancer Neoadjuvant Therapy, acronym: PRE-RET, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2025-01, studyFirstPostDateStruct date: 2024-03-13, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Universidad de La Frontera, class: OTHER, descriptionModule briefSummary: Breast cancer stands as the foremost cause of cancer-related deaths among women worldwide, with the highest incidence of any cancer type. The choice of therapeutic interventions hinges upon factors like cancer stage, cell subtype, and tumor size. Consequently, individuals with more aggressive tumors, such as HER+2 and Triple Negative, or larger tumors often undergo neoadjuvant chemotherapy before breast surgery. However, these anticancer treatments come with side effects like cancer-related fatigue, reduced functional capacity, and changes in body composition, notably skeletal muscle atrophy. Skeletal muscle loss correlates with heightened mortality rates, cardiotoxicity, and diminished quality of life, underscoring the need for early therapeutic interventions. One such promising strategy is prehabilitation, which involves resistance-exercise training aimed at bolstering skeletal muscle mass from the outset of the disease, even preceding breast surgery. Resistance-exercise training has shown favorable effects on women undergoing adjuvant therapy or survivors of breast cancer, however, its molecular and clinical effects in women with breast cancer undergoing neoadjuvant therapy are unknown., conditionsModule conditions: Prehabilitation, conditions: Breast Cancer, conditions: Postmenopause, conditions: Resistance Training, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 68, type: ESTIMATED, armsInterventionsModule interventions name: Prehabilitation with resistance-exercise training, interventions name: Usual care program, outcomesModule primaryOutcomes measure: Change in skeletal muscle mass (measured via Computed tomography (CT) scan), secondaryOutcomes measure: Change in arms and legs strength (measured via 1-Repetition Maximum (1RM) testing), secondaryOutcomes measure: Change in hand grip strength (measured via JAMAR handheld dynamometer), secondaryOutcomes measure: Change in physical performance measured via Short physical performance battery, secondaryOutcomes measure: Change in points quality of life measured via questionnaire European Organisation for Research and Treatment of Cancer (EORTC QLQ-C30), secondaryOutcomes measure: Change in points Brief fatigue inventory (BFI), secondaryOutcomes measure: Change in microgram per milliliter (µg/ml) of Human Insulin via ELISA, secondaryOutcomes measure: Change in pathological complete response rate, secondaryOutcomes measure: Change quantification proteins, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fundación Arturo López Pérez, city: Santiago, country: Chile, geoPoint lat: -33.45694, lon: -70.64827, locations facility: Department of Rehabilitation Sciences, Faculty of Medicine, Universidad de La Frontera. Temuco, Chile, city: Temuco, country: Chile, geoPoint lat: -38.73965, lon: -72.59842, hasResults: False