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

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ClinicalTrials.gov Identifier: NCT03860740
Recruitment Status : Recruiting
First Posted : March 4, 2019
Last Update Posted : March 4, 2019
Sponsor:
Collaborators:
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Faculty of Physical Activity and Sport Sciences (INEF)
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

Brief Summary:
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

Condition or disease Intervention/treatment
Breast Cancer Luminal B Other: Exercise Other: Stretching

Detailed 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.


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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Effect of Physical Exercise on Ki-67 Levels in Women With Operable Breast Cancer Hormonal Receptor Positive, HER2 Negative
Actual Study Start Date : June 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
High intensity physical exercise
Supervised Exercise Group: Customized and supervised exercise high intensity training program during 2-3 weeks previous surgery.
Other: Exercise
Exercise intervention adapted to maximum rate of oxygen consumption measured during incremental exercise (VO2level) of each patient, working between 60% to 100% VO2level. The activity will be walk-run in a treadmill. 10 sessions minimum

Control
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.
Other: Stretching
Stretching and relaxing exercise during 30 minutes. Same number of sessions as intervention group




Primary Outcome Measures :
  1. Tumor proliferation (Ki67) [ Time Frame: Post-surgery, an average of 6 months ]
    Tumor proliferation (Ki67) will be assessed immunohistochemically at basal biopsies versus post-surgery tumor samples.

  2. Proliferation Score [ Time Frame: Post-surgery, an average of 6 months ]
    A 50-gene quantitative polymerase chain reaction (qPCR) assay (PAM50) will be used to identify the intrinsic biological subtypes using RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tissue from baseline biopsies samples and post-surgery tumor samples.


Secondary Outcome Measures :
  1. Change from baseline molecular subtypes [ Time Frame: Post-surgery, an average of 6 months ]
    A 50-gene qPCR assay (PAM50) will be used to identify the intrinsic biological subtypes using RNA isolated from formalin-fixed, paraffin-embedded (FFPE) tissue from baseline biopsies samples and post-surgery tumor samples.

  2. Changes in tumor microenvironment: levels of Vascular endothelial growth factor (VEGF) [ Time Frame: Post-surgery, an average of 6 months ]
    VEGF will be evaluated on tissue from baseline biopsies samples and post-surgery tumor samples by Immunohistochemistry (IHC)

  3. Changes in tumor microenvironment: levels of factor Hypoxia-inducible factor 1 (HIF-1) [ Time Frame: Post-surgery, an average of 6 months ]
    HIF-1 will be evaluated on tissue from baseline biopsies samples and post-surgery tumor samples by Immunohistochemistry (IHC)

  4. Change in tumor microenvironment: levels of cleaved caspase 3 [ Time Frame: Post-surgery, an average of 6 months ]
    Levels of cleaved caspase 3 will be evaluated on tissue from baseline biopsies samples and post-surgery tumor samples by Immunohistochemistry (IHC)

  5. Oxygen uptake during peak exercise (VO2peak) [ Time Frame: Post-surgery, an average of 6 months ]
    VO2peak will be obtained of the Cardiopulmonary exercise testing (CPET) performed at baseline and after the exercise program until surgery.

  6. Change in body composition [ Time Frame: Post-surgery, an average of 6 months ]
    Change in body composition will be assessed by bioimpedance parameters. Bioelectrical impedance analysis (BIA) is a commonly used method for estimating body composition, and in particular body fat, and will be performed at baseline and after the exercise program until surgery.

  7. Change in fatigue levels [ Time Frame: Post-surgery, an average of 6 months ]
    Change in fatigue levels will be assessed by questionnaire Functional Assessment of Cancer Therapy: Fatigue (FACT-F). The physical well-being domain has 7 items with scores from 0 to 28 points; social/family well-being, 7 items with score from 0 to 28 points; emotional well-being, 6 items with score from 0 to 24 points; functional well-being, 7 items with score from 0 to 28 points; and fatigue subscale, 13 items with score from 0 to 52. Each item has five likert-type options graduated from 0 to 4: "Not at all", "A little bit"; Somewhat"; "Quite a bit"; "Very much'. The final score of FACT-F is obtained by adding the scores of the five domains, and may vary from 0 to 160 points. The higher the number of points, the better the quality of life and the less the fatigue of the patients is. To obtain the score, the negative questions are reverted; then the answers of the domains are added up, and a proportional average is carried out in case of non answered items.

  8. Change in quality of life levels [ Time Frame: Post-surgery, an average of 6 months ]
    Change in quality of life levels will be assessed by questionnaire Functional Assessment of Cancer Therapy: Breast Cancer (FACT-B). The FACT-B is a breast cancer-specific HRQoL instrument of the FACIT system. The 37-item are divided into five subscales, namely physical (PWB), social/family (SWB), emotional (EWB), functional well-beings (FWB), and the additional concerns for breast cancer (BCS). Each item is rated on a 5-point Likert scale. Negatively worded items were recoded such that a higher score indicates a better HRQoL. The FACT-B total score is the sum of scores of all five subscales.

  9. Change in depression levels [ Time Frame: Post-surgery, an average of 6 months ]
    Change in depression levels will be assessed by questionnaire Center for Epidemiologic Studies Depression Scale (CES-D). The CES-D is a 20-item measure assessing symptoms of depression with items phrased as self-statements (e.g., "I felt hopeful about the future"). Respondents rate how frequently each item applied to them over the course of the past week. Ratings were based on a 4-point Likert scale ranging from 0 (rarely or none of the time [less than 1 day]) to 3 (most or all of the time [5-7 days]).


Biospecimen Retention:   Samples With DNA
tumor samples Blood samples


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Women with newly diagnosed operable hormone receptor(HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancers
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03860740


Contacts
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Contact: Study Project Manager +34916592870 inicio_ensayos@geicam.org
Contact: Start-Up Unit Manager +34916592870 inicio_ensayos@geicam.org

Locations
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Spain
Hospital General Universitario Gregorio Marañón Recruiting
Madrid, Spain, 28007
Contact: Investigador Principal       geicam@geicam.org   
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Faculty of Physical Activity and Sport Sciences (INEF)
Investigators
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Study Director: Study Director Hospital General Universitario Gregorio Marañón
Study Director: Study Director Fundación Jimenez Díaz

Additional Information:
Publications:

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Responsible Party: Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT03860740     History of Changes
Other Study ID Numbers: GEICAM/2014-09
First Posted: March 4, 2019    Key Record Dates
Last Update Posted: March 4, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Spanish Breast Cancer Research Group:
Physical exercise
Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases