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Dose-Response of Aerobic Training in Post-Menopausal Women at High-Risk for Development of Breast Cancer

This study is currently recruiting participants.
Verified October 2017 by Memorial Sloan Kettering Cancer Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02494869
First Posted: July 10, 2015
Last Update Posted: October 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center
July 8, 2015
July 10, 2015
October 20, 2017
July 2015
July 2019   (Final data collection date for primary outcome measure)
gene expression patterns of non-neoplastic breast epithelial cells in post-menopausal women [ Time Frame: 2 years ]
Fresh-frozen tissue sections from normal breast epithelial cell samples before and after aerobic training will be cut and stained using hematoxylin & eosin, and the morphological features will be reviewed.
gene expression patterns of non-neoplastic breast epithelial cells in post-menopausal women [ Time Frame: 2 years ]
Fresh-frozen or RNAlater tissue sections from normal breast epithelial cell samples before and after aerobic training will be cut and stained using hematoxylin & eosin, and the morphological features will be reviewed.
Complete list of historical versions of study NCT02494869 on ClinicalTrials.gov Archive Site
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Dose-Response of Aerobic Training in Post-Menopausal Women at High-Risk for Development of Breast Cancer
Dose-Response of Aerobic Training in Post-Menopausal Women at High-Risk for Development of Breast Cancer
This study is being done to look at the effect that different amounts of progressive exercise training has on risk factors associated with developing breast cancer. These risk factors include exercise capacity, body weight, and body composition, as well as the expression of certain genes and levels of inflammatory factors in your breast tissue.
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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
High Risk for Developing Breast Cancer
  • Behavioral: Nonlinear Aerobic Training
  • Other: Height, Weight, BMI measure
  • Other: Blood draw
  • Other: Cardiopulmonary exercise test
  • Experimental: Nonlinear Aerobic Training (75 minutes/week)
    The ultimate goal is for participants to complete 75 minutes/week of structured aerobic training per week at 55% to 100% of the individually determined exercise capacity (VO2peak) determined from the (CPETs performed at baseline, midpoint, and Study Follow-Up. The 75 min/wk will be achieved via 3 individual supervised aerobic training sessions at approximately 25 minutes/session.
    Interventions:
    • Behavioral: Nonlinear Aerobic Training
    • Other: Height, Weight, BMI measure
    • Other: Blood draw
    • Other: Cardiopulmonary exercise test
  • Experimental: Nonlinear Aerobic Training (150 minutes/week)
    The ultimate goal is for participants to complete 150 minutes/week of structured aerobic training per week at 55% to 100% of the individually determined exercise capacity (VO2peak) determined from the CTPETs test performed at baseline, midpoint, and Study Follow-Up. The 150 minutes/week will be achieved by completing 3 aerobic training sessions/week for approximately 50 minutes/session.
    Interventions:
    • Behavioral: Nonlinear Aerobic Training
    • Other: Height, Weight, BMI measure
    • Other: Blood draw
    • Other: Cardiopulmonary exercise test
  • Experimental: Nonlinear Aerobic Training (300 minutes/week)
    The ultimate goal is for participants to complete 300 minutes/week of aerobic training per week at 55% to 100% of the individually determined exercise capacity (VO2peak) determined from CPETs performed at baseline, midpoint, and Study Follow-Up. The 300 minutes/week will be achieved by completing 5 aerobic training sessions/week for approximately 60 minutes/session. A minimum of 3 sessions/week are required to be supervised while the remaining 2 sessions can be supervised or unsupervised home-based.
    Interventions:
    • Behavioral: Nonlinear Aerobic Training
    • Other: Height, Weight, BMI measure
    • Other: Blood draw
    • Other: Cardiopulmonary exercise test
  • Active Comparator: General Physical Activity
    Usual care patients will receive a home-based, general physical activity program. Specifically, all patients assigned to general physical activity will receive an initial, in-person consultation with staff exercise physiologist outlining a structured home-based aerobic walking program with a goal up to 150 minutes per week outside of their normal daily activity. Patients will be provided with a fitness tracker (e.g. FitBit) to evaluate exercise duration and intensity. Patients will be asked to records type, duration, and average heart rate during sessions in an exercise log to assess compliance. Staff exercise physiologists will contact patients by telephone or in person on a monthly, or less, basis to check progress, answer questions and record compliance.
    Intervention: Other: Blood draw
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
July 2019
July 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women at high-risk of breast cancer as defined by one of the following:

    • Cytologically confirmed atypical hyperplasia
    • Cytologically confirmed LCIS
    • BRCA1 and/or BRCA2 mutation carriers
    • Predicted lifetime risk of breast cancer >20% based on family history)
    • Predicted 10-year risk of breast cancer of ≥ 2.31%
    • Predicted 5-year risk of breast cancer ≥ 1.67%
  • Postmenopausal women, defined as:

    • Age > 45 with no menses for at least 2 years
    • Age < 80 years old
  • Weight <205 kilograms
  • Must a negative mammogram or negative breast MRI within 1 year of protocol required baseline core biopsy

    o Patients positive for BRCA mutations must have a negative breast MRI within 1 year of protocol-required baseline core biopsy

  • Clinical breast exam interpreted as benign (not suspicious for cancer) at MSK
  • Performing less than 75 minutes of structured moderate-intensity or strenuous-intensity exercise per week
  • Able to complete an acceptable baseline CPET in the absence of high risk ECG findings or other inappropriate response to exercise as determined by the investigator.
  • Able to achieve an acceptable peek baseline CPET defined as by any of the following criteria:

    • achieving a plateau in oxygen consumption concurrent an with increase in power output;
    • a respiratory exchange ratio ≥ 1.10;
    • attainment of maximal predicted heart rate (HRmax) (i.e., within 10 bpm of age-predicted [HRmax = 220-Age[years]) Volitional exhaustion, as measured by a rating of perceived exertion (RPE) ≥ 18 on the BORG scale.

Exclusion Criteria:

  • Use of any selective estrogen receptor modulator or aromatase inhibitor within 6 months of randomization, including, but not limited to: (tamoxifen, raloxifene, arzoxifene, acolbifene, anastrozole, exemestane, and letrozole)
  • Enrollment on an interventional investigational study
  • Bilateral breast implants
  • Any newly identified breast abnormality requiring surgical excision
  • History of any of the following:
  • Invasive cancer diagnosis
  • DCIS
  • Flat epithelial atypia
  • Any current invasive cancer diagnosis
  • Metastatic malignancy of any kind
  • Any other condition or intercurrent illness that in the opinion of the investigator makes the subject a poor candidate for core biopsy or the trial
  • Mental impairment leading to inability to cooperate.
  • Room air desaturation at rest ≤85%
  • Any of the following absolute contraindications to cardiopulmonary exercise testing and/or aerobic training:
  • Acute myocardial Infarction (within 3-5 days of any planned study procedures);
  • Unstable angina;
  • Uncontrolled arrhythmia causing symptoms or hemodynamic compromise;
  • Recurrent syncope;
  • Active endocarditis;
  • Acute myocarditis or pericarditis;
  • Symptomatic severe aortic stenosis;
  • Uncontrolled heart failure;
  • Acute pulmonary embolus or pulmonary infarction within 3 months of any planned study procedures;
  • Thrombosis of lower extremities;
  • Suspected dissecting aneurysm;
  • Uncontrolled asthma;
  • Pulmonary edema;
  • Respiratory failure;
  • Acute non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis); or
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Post-Menopausal Women
18 Years and older   (Adult, Senior)
No
Contact: Lee Jones, PhD 646-888-8103
Contact: Neil Iyengar, MD 646-888-4714
United States
 
 
NCT02494869
15-093
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Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
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Principal Investigator: Lee Jones, PhD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP