Effect of Physical Exercise on Tumor Proliferation of Luminal B Breast Cancer Patients (EFIK)

Spanish Breast Cancer Research Group (GEICAM)

Status: Completed

Conditions: Breast Cancer; Luminal B

Treatments: Other: Exercise; Other: Stretching

Study type: Observational

Funder types: Other

Identifiers

NCT03860740

GEICAM/2014-09

Details and patient eligibility

About

Observational study to evaluate the effect of physical exercise prior to surgery and adjuvant systemic treatment in women with newly diagnosed operable hormone receptor(HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancers

Full description

Effect of exercise on tumor aggressiveness and the impact on patients' quality of life.

Exercise is a safe and effective treatment for women diagnosed with breast cancer (BC), that has an integral benefit during and after treatments, however, the effect at the tumour microenvironment it is unknown; previous studies have evaluated the association between exercise and BC, finding a positive influence on it, which suggest that exercise could reduce the aggressiveness of the tumour. This study will explore the exercise impact in tumor microenvironment, as part of the therapy given to the patients prior to surgery and treatment. In addition, different serum biomarkers involved and the tailoring of exercise for these women will be evaluated. The effect of exercise on treatments secondary effects, biomarkers and quality of life will be evaluated after 6 months of BC surgery. This project will open a window of opportunity to explore new translational research as well as new treatment vias to the patients of this breast cancer subgroup.

Enrollment: 12 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed, previously untreated clinical stage I-IIIA without previous treatment.
• ER positive breast cancer according to local results. (RH+ is defined as ≥ 1% assessed by Immunohistochemistry (IHC) to Estrogen Receptor (ER) and/or Progesterone Receptor (P)E).
• HER2 negative in the primary tumour according to local results. (HER2 confirmation should be done following the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) 2013 guidelines)
• Scheduled to undergo surgical resection.
• Ki67 levels must be over 13%, according to local results.
• At least 14 days from enrolment to planned surgical resection.
• Karnofsky performance status of at least 70% at study entry or 0-1 level in Eastern Cooperative Oncology Group (ECOG) Scale.
• Signed consent prior to initiation of study-related procedures.

Exclusion criteria

• Schedule to receive any form of induction/neoadjuvant therapy
• Significant cardiac disease (ventricular ejection fraction of <50%, unstable angina, placement of cardiac stents and myocardial infarction within precious 6 months)
• Any pulmonary dysfunction which may affect to the exercise program perform.
• Any mental disease or condition that compromise the physical, psychological and emotional patients' wellness or affect to the process.
• Contraindications to a cardiopulmonary exercise test as recommended by the American Thoracic Society.

Trial design

12 participants in 2 patient groups

High intensity physical exercise

Description:

Supervised Exercise Group: Customized and supervised exercise high intensity training program during 2-3 weeks previous surgery.

Treatment:

Other: Exercise

Control

Description:

Supervised Stretching Group: a stretching and body balance classes will be developed to control the possible confounders and to control the exercise level of participants.

Treatment:

Other: Stretching