Effects of a Physical Exercise Intervention During Neoadjuvant Chemotherapy in Women With Breast Cancer
NCT ID: NCT04135586
Last Updated: 2024-06-27
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
80 participants
INTERVENTIONAL
2020-01-01
2026-12-01
Brief Summary
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Detailed Description
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Principal aim:
To assess in women with triple-negative breast cancer receiving neo-adjuvant chemotherapy the effects of an intense physical exercise program (intervention group) on physical capacity, compared with a control group not meeting the minimum exercise recommendations of the World Health Organization (WHO).
Secondary aims:
To compare the following outcomes in both groups: body composition, and quality of life and depression/anxiety.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
SINGLE
Study Groups
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Exercise
The patients in this arm will follow an exercise program for 24 weeks (i.e., during neo-adjuvant treatment), with two sessions per week including both aerobic and resistance training. Exercise intensity will range between 65% and 100% of the maximum score in the scale of Rated Perceived Exertion (RPE).
Exercise training
Exercise program for 24 weeks (with neo-adjuvant treatment), with two sessions per week including both moderate-to-intense aerobic and resistance training. The intensity of each type of exercise will range between 65% and 100% of the maximum score in the Rated Perceived Exertion (RPE) scale.
Control
The patients follow their usual habits as well as a Yoga program. They will also receive educational sessions on the benefits of regular physical activity (brisk walking).
Control
Yoga + educational program
Interventions
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Exercise training
Exercise program for 24 weeks (with neo-adjuvant treatment), with two sessions per week including both moderate-to-intense aerobic and resistance training. The intensity of each type of exercise will range between 65% and 100% of the maximum score in the Rated Perceived Exertion (RPE) scale.
Control
Yoga + educational program
Eligibility Criteria
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Inclusion Criteria
* Must have triple negative breast cancer (i.e., negative for estrogen receptors, progesterone receptors, and excess HER2 protein) of size \> or equal to 15 mm
Exclusion Criteria
25 Years
75 Years
FEMALE
No
Sponsors
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Universidad Europea de Madrid
OTHER
Responsible Party
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Alejandro Lucia
Professor
Locations
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Hospital Universitario Quirónsalud de Pozuelo (HUQP)
Madrid, , Spain
Countries
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Facility Contacts
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Other Identifiers
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UEM Quirón
Identifier Type: -
Identifier Source: org_study_id
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