protocolSection identificationModule nctId: NCT06360809, orgStudyIdInfo id: 2024 PARINEFC 00001, briefTitle: Prehabilitation Exercise Program in Breast Cancer: Effects on Quality of Life and Tumor Microenvironment (PEP_BC), acronym: PEP_BC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-22, primaryCompletionDateStruct date: 2025-06, completionDateStruct date: 2025-06, studyFirstPostDateStruct date: 2024-04-11, lastUpdatePostDateStruct date: 2024-04-11, sponsorCollaboratorsModule leadSponsor name: Institut Nacional d'Educacio Fisica de Catalunya, class: OTHER, collaborators name: ICFO - The Institute of Photonics Sciences, collaborators name: Hospital Clinic of Barcelona, collaborators name: Institut d'Investigacions Biomèdiques August Pi i Sunyer, collaborators name: Universidad San Jorge, descriptionModule briefSummary: To improve the health and quality of life of breast cancer (BC) patients, researchers are focusing on prehabilitation strategies like physical exercise, preparing patients both mentally and physically for clinical and surgical procedures, potentially reducing complications. Physical exercise is also recognized as pivotal in optimizing chemotherapy. It can improve blood flow and oxygen supply in the microenvironment of the tumor (MT), potentially enhancing chemotherapy effectiveness. Although previous research has shown the benefits of preoperative exercise combined with chemotherapy in various cancer types, including BC, further investigation is needed into the exact effects of prehabilitation exercise (PE) on MT physiology.This study aims to provide valuable insights into the potential benefits of PE for BC patients and its impact on the tumor microenvironment. The hypothesis is that PE in BC patients will improve their quality of life, reduce fatigue, increase muscle mass, decrease fat mass, and enhance physical fitness. Additionally, beneficial acute hemodynamic changes, particularly increased blood flow following PE sessions, and hemodynamic adaptations involving higher levels of oxygenated hemoglobin, increased blood flow, greater oxygen saturation, and a higher metabolic rate of oxygen, are expected.The study will include 76 participants aged 18-65 years, meeting specific criteria such as a diagnosis of hormone receptor-positive BC, no medical contraindications for exercise, no metastatic cancer, and no structured exercise in the last six months. These participants will be randomly assigned to a PE group or a control group. The study will consist of three phases: Phase 1 involves pre-intervention assessments, Phase 2 includes a 4-week PE intervention with three weekly sessions, and Phase 3 encompasses post-intervention and post-surgery assessments. The 4-week PE intervention in Phase 2 will include strength and aerobic training. Quality of life and fatigue assessments will use questionnaires, and measurements will be made for fat mass, lean mass, bone density, and cardiorespiratory fitness. Strength measurements will be taken, and shoulder mobility will be evaluated. Hemodynamics of the MT will be assessed using a hybrid device combining Near-Infrared Spectroscopy and Diffuse Correlation Spectroscopy with ultrasound., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: Prehabilitation exercise program, outcomesModule primaryOutcomes measure: Quality of life score, primaryOutcomes measure: Cancer quality of life score, primaryOutcomes measure: Cancer-related fatigue, primaryOutcomes measure: Body composition, primaryOutcomes measure: Bone density, primaryOutcomes measure: Cardiorespiratory fitness, primaryOutcomes measure: Maximum isometric manual grip strength, primaryOutcomes measure: Upper body maximum strength, primaryOutcomes measure: Lower body maximum strength, primaryOutcomes measure: Shoulder range of motion, primaryOutcomes measure: Relative oxyhemoglobin concentration ([02Hb]) in the microenvironment of the tumor, primaryOutcomes measure: Relative deoxyhemoglobin concentration ([HHb]) in the microenvironment of the tumor, primaryOutcomes measure: Oxygen saturation (StO2) in the microenvironment of the tumor, primaryOutcomes measure: Blood flow (BF) in the microenvironment of the tumor, secondaryOutcomes measure: Height, secondaryOutcomes measure: Body mass, secondaryOutcomes measure: Body mass index, secondaryOutcomes measure: Wait circumference, secondaryOutcomes measure: Anthropometric measurements, secondaryOutcomes measure: Bioimpedance measurements, secondaryOutcomes measure: Maximal heart rate, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hospital Clínic, status: RECRUITING, city: Barcelona, zip: 08036, country: Spain, contacts name: Eduard Mension, MD, role: CONTACT, email: mension@clinic.cat, contacts name: Albert Busquets, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Lucia Sagarra-Moreno, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Esther Valera, MSc, role: SUB_INVESTIGATOR, contacts name: Graciela Martínez-Pallí, MD, role: SUB_INVESTIGATOR, contacts name: Raquel Sebio, PhD, role: SUB_INVESTIGATOR, contacts name: Blai Ferrer-Uris, PhD, role: SUB_INVESTIGATOR, contacts name: Turgut Durduran, PhD, role: SUB_INVESTIGATOR, contacts name: Mireia Mora, MD, role: SUB_INVESTIGATOR, contacts name: Eduard Mension, MD, role: SUB_INVESTIGATOR, contacts name: Helena Castillo, MD, role: SUB_INVESTIGATOR, contacts name: Rosa Angulo-Barroso, PhD, role: SUB_INVESTIGATOR, contacts name: Alfredo Irurtia, PhD, role: SUB_INVESTIGATOR, contacts name: Marta Carrasco-Marginet, PhD, role: SUB_INVESTIGATOR, contacts name: Alex Cebrián-Ponce, MSc, role: SUB_INVESTIGATOR, contacts name: Ferran Faixat, role: SUB_INVESTIGATOR, contacts name: Quim Rosales, role: SUB_INVESTIGATOR, contacts name: Raquel Martinez-Reviejo, MSc, role: SUB_INVESTIGATOR, contacts name: Paula Bonay, BS, role: SUB_INVESTIGATOR, geoPoint lat: 41.38879, lon: 2.15899, hasResults: False