Effect of Physical Exercise on Tumor Proliferation of Luminal B Breast Cancer Patients
NCT ID: NCT03860740
Last Updated: 2023-01-13
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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COMPLETED
12 participants
OBSERVATIONAL
2016-06-30
2021-06-08
Brief Summary
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Detailed Description
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Exercise is a safe and effective treatment for women diagnosed with breast cancer (BC), that has an integral benefit during and after treatments, however, the effect at the tumour microenvironment it is unknown; previous studies have evaluated the association between exercise and BC, finding a positive influence on it, which suggest that exercise could reduce the aggressiveness of the tumour. This study will explore the exercise impact in tumor microenvironment, as part of the therapy given to the patients prior to surgery and treatment. In addition, different serum biomarkers involved and the tailoring of exercise for these women will be evaluated. The effect of exercise on treatments secondary effects, biomarkers and quality of life will be evaluated after 6 months of BC surgery. This project will open a window of opportunity to explore new translational research as well as new treatment vias to the patients of this breast cancer subgroup.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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High intensity physical exercise
Supervised Exercise Group: Customized and supervised exercise high intensity training program during 2-3 weeks previous surgery.
Exercise
Exercise intervention adapted to maximum rate of oxygen consumption measured during incremental exercise (VO2level) of each patient, working between 60% to 100% VO2level. The activity will be walk-run in a treadmill. 10 sessions minimum
Control
Supervised Stretching Group: a stretching and body balance classes will be developed to control the possible confounders and to control the exercise level of participants.
Stretching
Stretching and relaxing exercise during 30 minutes. Same number of sessions as intervention group
Interventions
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Exercise
Exercise intervention adapted to maximum rate of oxygen consumption measured during incremental exercise (VO2level) of each patient, working between 60% to 100% VO2level. The activity will be walk-run in a treadmill. 10 sessions minimum
Stretching
Stretching and relaxing exercise during 30 minutes. Same number of sessions as intervention group
Eligibility Criteria
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Inclusion Criteria
* ER positive breast cancer according to local results. (RH+ is defined as ≥ 1% assessed by Immunohistochemistry (IHC) to Estrogen Receptor (ER) and/or Progesterone Receptor (P)E).
* HER2 negative in the primary tumour according to local results. (HER2 confirmation should be done following the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2013 guidelines)
* Scheduled to undergo surgical resection.
* Ki67 levels must be over 13%, according to local results.
* At least 14 days from enrolment to planned surgical resection.
* Karnofsky performance status of at least 70% at study entry or 0-1 level in Eastern Cooperative Oncology Group (ECOG) Scale.
* Signed consent prior to initiation of study-related procedures.
Exclusion Criteria
* Significant cardiac disease (ventricular ejection fraction of \<50%, unstable angina, placement of cardiac stents and myocardial infarction within precious 6 months)
* Any pulmonary dysfunction which may affect to the exercise program perform.
* Any mental disease or condition that compromise the physical, psychological and emotional patients' wellness or affect to the process.
* Contraindications to a cardiopulmonary exercise test as recommended by the American Thoracic Society.
18 Years
FEMALE
No
Sponsors
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Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
OTHER
Faculty of Physical Activity and Sport Sciences (INEF)
UNKNOWN
Spanish Breast Cancer Research Group
OTHER
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Hospital General Universitario Gregorio Marañón
Study Director
Role: STUDY_DIRECTOR
Fundación Jimenez Díaz
Locations
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Hospital General Universitario Gregorio Marañón
Madrid, , Spain
Countries
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References
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Related Links
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Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group
Other Identifiers
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GEICAM/2014-09
Identifier Type: -
Identifier Source: org_study_id
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