Effects of a Physical Exercise Intervention During Neoadjuvant Chemotherapy in Women With Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of a Physical Exercise Intervention at the Molecular Systemic and Tumor Level Performed During Neoadjuvant Chemotherapy in Women With Breast Cancer

Conditions
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Physical Exercise

Intervention / Treatment
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* Other: Exercise training
* Other: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Physical exercise intervention (24 weeks)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>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<br>* 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.<br>|
| Other: Control<br>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). | Other: Control<br>* Yoga + educational program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiorespiratory fitness | peak rate of oxygen consumption (ml/kg/min) reached during a graded treadmill exercise test until exhaustion | Change from baseline to end of intervention (i.e., after 24 weeks) | 
| muscle dynamic strength | Time (seconds) to perform the sit-to-stand (STS) test (five consecutive repetitions of sitting down and uprising from a chair) | Change from baseline to end of intervention (i.e., after 24 weeks) | 
| handgrip strength | handgrip strength measured using a dynamometer and scores recorded in kilograms (to the nearest 0.1 kg) | Change from baseline to end of intervention (i.e., after 24 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life (Breast Cancer-Specific Quality of Life Questionnaire [QLQ-BR23]) | 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. | Change from baseline to end of intervention (i.e., after 24 weeks) | 
| Body composition (fat mass) | fat mass (% of whole body mass), evaluated by dual energy X-ray absorptiometry | Change from baseline to end of intervention (i.e., after 24 weeks) | 
| Body composition (lean body mass) | lean body mass (% of whole body mass), evaluated by dual energy X-ray absorptiometry | Change from baseline to end of intervention (i.e., after 24 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exercise, high interval training, resistance exercise