Recruiting NCT04135586

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

No phase Interventional Physical Exercise

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Exercise training, Control.
Who it may be relevant to: Registry conditions: Physical Exercise. Basic parameters: 25 years — 75 years · Female.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: Spain
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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:

Secondary aims:

To compare the following outcomes in both groups: body composition, and quality of life and depression/anxiety.

Interventions

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.
Other Control
Yoga + educational program

Primary outcome measures

Cardiorespiratory fitness [Time frame: Change from baseline to end of intervention (i.e., after 24 weeks)]
muscle dynamic strength [Time frame: Change from baseline to end of intervention (i.e., after 24 weeks)]
handgrip strength [Time frame: Change from baseline to end of intervention (i.e., after 24 weeks)]

Secondary outcome measures (3)

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)]
Body composition (fat mass) [Time frame: Change from baseline to end of intervention (i.e., after 24 weeks)]
Body composition (lean body mass) [Time frame: Change from baseline to end of intervention (i.e., after 24 weeks)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Single blind
Primary purpose: Other

Study locations

Spain · 2 centers

Hospital Universitario Quirónsalud de Pozuelo (HUQP) — Madrid
Lgcortijo@Gmail.Com — Madrid

Identifiers

NCT: NCT04135586 · UEM Quirón

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗