Clinical trial NCT04135586: Effects of a Physical Exercise Intervention During Neoadjuvant Chemotherapy in Women With Breast Cancer
Official title: Effects of a Physical Exercise Intervention at the Molecular Systemic and Tumor Level Performed During Neoadjuvant Chemotherapy in Women With Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Physical Exercise
Keywords: exercise
high interval training
resistance exercise
Lead sponsor: Universidad Europea de Madrid
Sponsor class: OTHER
First posted: 2019-10-22
Enrollment: 80
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Physical exercise intervention (24 weeks)
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Cardiorespiratory fitness
timeFrame: Change from baseline to end of intervention (i.e., after 24 weeks)
measure: muscle dynamic strength
timeFrame: Change from baseline to end of intervention (i.e., after 24 weeks)
measure: handgrip strength
timeFrame: Change from baseline to end of intervention (i.e., after 24 weeks)
Secondary outcomes:
measure: Health-related quality of life (Breast Cancer-Specific Quality of Life Questionnaire [QLQ-BR23])
timeFrame: Change from baseline to end of intervention (i.e., after 24 weeks)
measure: Body composition (fat mass)
timeFrame: Change from baseline to end of intervention (i.e., after 24 weeks)
measure: Body composition (lean body mass)
timeFrame: Change from baseline to end of intervention (i.e., after 24 weeks)
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Universitario Quirónsalud de Pozuelo (HUQP)
city: Madrid
country: Spain
facility: Lgcortijo@Gmail.Com
Study officials:
References: