Effects of a Physical Exercise Intervention at the Molecular Systemic and Tumor Level Performed During Neoadjuvant Chemotherapy in Women With Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Physical Exercise
- Sponsor
- Universidad Europea de Madrid
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- handgrip strength
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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).
Detailed Description
Justification and aims Breast cancer is the fourth most common type of cancer worldwide and the first among women in Spain. It is also the type of cancer with the highest mortality. Several studies have assessed the effects of exercise performed in the neo-adjuvant period, but there is heterogeneity among them. 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.
Investigators
Alejandro Lucia
Professor
Universidad Europea de Madrid
Eligibility Criteria
Inclusion Criteria
- •Diagnosed with breast carcinoma in the 'Hospital Universitario Quirónsalud de Pozuelo' (Madrid, Spain) and following neoadjuvant therapy in the aforementioned center.
- •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
- •Not meeting all of the above.
Outcomes
Primary Outcomes
handgrip strength
Time Frame: Change from baseline to end of intervention (i.e., after 24 weeks)
handgrip strength measured using a dynamometer and scores recorded in kilograms (to the nearest 0.1 kg)
muscle dynamic strength
Time Frame: Change from baseline to end of intervention (i.e., after 24 weeks)
Time (seconds) to perform the sit-to-stand (STS) test (five consecutive repetitions of sitting down and uprising from a chair)
Cardiorespiratory fitness
Time Frame: Change from baseline to end of intervention (i.e., after 24 weeks)
peak rate of oxygen consumption (ml/kg/min) reached during a graded treadmill exercise test until exhaustion
Secondary Outcomes
- Body composition (fat mass)(Change from baseline to end of intervention (i.e., after 24 weeks))
- Body composition (lean body mass)(Change from baseline to end of intervention (i.e., after 24 weeks))
- Health-related quality of life (Breast Cancer-Specific Quality of Life Questionnaire [QLQ-BR23])(Change from baseline to end of intervention (i.e., after 24 weeks))