Effects of a Physical Exercise Intervention During Neoadjuvant Chemotherapy in Women With Breast Cancer (NEOLIFE)
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|ClinicalTrials.gov Identifier: NCT04135586|
Recruitment Status : Not yet recruiting
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Physical Exercise||Other: Exercise training Other: Control||Not Applicable|
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.
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).
To compare the following outcomes in both groups: body composition, and quality of life and depression/anxiety.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Physical exercise intervention (24 weeks)|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effects of a Physical Exercise Intervention at the Molecular Systemic and Tumor Level Performed During Neoadjuvant Chemotherapy in Women With Breast Cancer|
|Estimated Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||November 1, 2021|
|Estimated Study Completion Date :||January 1, 2022|
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).
Other: 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.
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).
Yoga + educational program
- 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
- 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)
- 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)
- Health-related quality of life (Breast Cancer-Specific Quality of Life Questionnaire [QLQ-BR23]) [ Time Frame: Change from baseline to end of intervention (i.e., after 24 weeks) ]The QLQ-C30 is a multidimensional cancer HRQoL questionnaire that contains 30 items assessing six functional and nine symptom scales. Results from this questionnaire are transformed into scores ranging from 0 to 100 according to European Organization for Research and Treatment of Cancer (EORTC) scoring, with higher scores in the functioning scales indicating a better functional status and global HRQoL, and higher scores on the symptoms' scales indicating more symptoms.
- Body composition (fat mass) [ Time Frame: Change from baseline to end of intervention (i.e., after 24 weeks) ]fat mass (% of whole body mass), evaluated by dual energy X-ray absorptiometry
- Body composition (lean body mass) [ Time Frame: Change from baseline to end of intervention (i.e., after 24 weeks) ]lean body mass (% of whole body mass), evaluated by dual energy X-ray absorptiometry