Prehabilitation Exercise Program in Breast Cancer: Effects on Quality of Life and Tumor Microenvironment (PEP_BC)
NCT ID: NCT06360809
Last Updated: 2024-04-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
76 participants
INTERVENTIONAL
2024-03-22
2025-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PEP group
Breast cancer patients involved in a prehabilitation physical exercise program
Prehabilitation exercise program
After the allocation, the intervention will consist of a prehabilitation program lasting 4 weeks. Each week, there will be three sessions, with one being face-to-face and the other two being unsupervised sessions but with online video-support. Face-to-face sessions will be organized in small groups, and each patient of the PEP group will have an individualized plan based on data obtained during the initial assessment. Each session will include a combination of strength training and moderate aerobic training in a circuit format with movements especially involving the upper body.
CON group
Breast cancer patients not involved in a prehabilitation physical exercise program
No interventions assigned to this group
Interventions
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Prehabilitation exercise program
After the allocation, the intervention will consist of a prehabilitation program lasting 4 weeks. Each week, there will be three sessions, with one being face-to-face and the other two being unsupervised sessions but with online video-support. Face-to-face sessions will be organized in small groups, and each patient of the PEP group will have an individualized plan based on data obtained during the initial assessment. Each session will include a combination of strength training and moderate aerobic training in a circuit format with movements especially involving the upper body.
Eligibility Criteria
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Inclusion Criteria
* Have a diagnosis of hormone receptor-positive breast cancer (ER and PR).
* Have no medical contraindications that prevent them from participating in physical exercise.
* Have four weeks period between diagnosis and surgery
Exclusion Criteria
* Presence of uncontrolled serious medical illness
* Presence of any medical, psychological or social problem that could seriously interfere with the patient's participation in the study
* Those who have engaged in structured physical exercise in the last 6 months.
18 Years
65 Years
FEMALE
No
Sponsors
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ICFO - The Institute of Photonics Sciences
UNKNOWN
Hospital Clinic of Barcelona
OTHER
Institut d'Investigacions Biomèdiques August Pi i Sunyer
OTHER
Universidad San Jorge
OTHER
Institut Nacional d'Educacio Fisica de Catalunya
OTHER
Responsible Party
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Albert Busquets Faciaben
Principal Investigator
Principal Investigators
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Albert Busquets, PhD
Role: PRINCIPAL_INVESTIGATOR
Institut Nacional d'Educació Física de Catalunya
Lucia Sagarra-Romero, PhD
Role: PRINCIPAL_INVESTIGATOR
Universidad San Jorge
Locations
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Hospital Clínic
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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References
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Other Identifiers
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2024 PARINEFC 00001
Identifier Type: -
Identifier Source: org_study_id
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