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Exercise Program in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy (WISER-NET)

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.
 
ClinicalTrials.gov Identifier: NCT03280836
Recruitment Status : Recruiting
First Posted : September 13, 2017
Last Update Posted : December 9, 2019
Sponsor:
Collaborator:
NRG Oncology
Information provided by (Responsible Party):
Kathleen Sturgeon, Milton S. Hershey Medical Center

Tracking Information
First Submitted Date  ICMJE August 31, 2017
First Posted Date  ICMJE September 13, 2017
Last Update Posted Date December 9, 2019
Actual Study Start Date  ICMJE August 3, 2017
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2017)
  • Acceptability: Percent of eligible patients that provide consent and are enrolled in the study. [ Time Frame: 1 year ]
    Acceptability of the study will be assessed by documenting the percent of eligible patients that provide consent and are enrolled in the study.
  • Feasibility of the study will be assessed by documenting participant adherence to the exercise intervention. [ Time Frame: 18 months ]
    Heart monitors will be used to quantify adherence.
  • Efficacy of the intervention will be assessed by determining the change in cardiopulmonary fitness level between control and experimental group using cardiopulmonary exercise test [ Time Frame: 18 months ]
    Participants will complete a baseline and follow up cardiopulmonary exercise test.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exercise Program in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
Official Title  ICMJE Women In Steady Exercise Research - Neoadjuvant Exercise Trial
Brief Summary The investigators seek to conduct a home based exercise intervention in breast cancer patients whom elect to undergo neoadjuvant chemotherapy. The primary aim of the study is to determine whether breast cancer patients can be enrolled, randomized, retained, and comply with exercise program; and, the feasibility of acquiring, managing and analyzing clinical data.
Detailed Description Several national and international agencies recommend exercise participation for all persons following a cancer diagnosis. The current evidence suggests that aerobic exercise training is safe during primary adjuvant therapy and improves cardiopulmonary function and patient related outcomes. Cardiopulmonary fitness is highly predictive of overall and cardiovascular specific mortality in women. Specifically, an increase in cardiopulmonary fitness of approximately 10% has been associated with a 19% reduction in risk for CV mortality. This is important as breast cancer patients already present at diagnosis with 31% lower cardiopulmonary fitness levels compared to healthy age-matched women. This enhanced risk for cardiovascular mortality in breast cancer patients is further compounded by cardiotoxic chemotherapy, which causes permanent cardiac damage. Few studies have tested the efficacy of exercise prescriptions that incorporate high intensity aerobic exercise training in cancer patients, especially those receiving chemotherapy. Therefore, the investigators seek to conduct an at home aerobic exercise training intervention in breast cancer patients whom elect to undergo neoadjuvant chemotherapy
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Participants are randomized to the intervention or control arm.
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Breast Neoplasm
  • Physical Activity
Intervention  ICMJE Behavioral: Exercise

All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity.

The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max.

Study Arms  ICMJE
  • No Intervention: Control
    We ask that participants in the control arm do not start an exercise program.
  • Experimental: Exercise

    Participants in the experimental arm will be asked to complete the exercise intervention with 80% or greater adherence.

    Participants will work towards the goal of 75 or more minutes a week of moderate to vigorous exercise. Participants are provided an exercise toolkit and directed on exercise progression based on personal fitness level.

    Intervention: Behavioral: Exercise
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 11, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2021
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

3.1 Inclusion Criteria

  • Women with a breast cancer diagnosis (Stage I-IIIC)
  • Sedentary (< 75 min/wk of moderate intensity exercise over the past month)
  • No previous history of anthracycline based chemotherapy
  • Absence of heart disease (clinical diagnosis of coronary artery disease, arrhythmias, congenital heart defects, dilated cardiomyopathy, or valvular heart disease)
  • Absence of contraindications for neoadjuvant chemotherapy
  • Scheduled to receive neoadjuvant chemotherapy
  • Primary attending oncologist approval

3.2 Exclusion Criteria

  • Absolute contraindications for exercise stress testing

    • acute myocardial infarction (3-5 days)
    • unstable angina
    • uncontrolled arrhythmias causing symptoms or hemodynamic compromise
    • syncope
    • acute endocarditis
    • acute myocarditis or pericarditis
    • uncontrolled heart failure
    • acute pulmonary embolus or pulmonary infarction
    • thrombosis of lower extremities
    • suspected dissecting aneurysm
    • uncontrolled asthma
    • pulmonary edema
    • room air desaturation at rest ≤85%
    • respiratory failure
    • acute noncardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
    • mental impairment leading to inability to cooperate
    • decisional impairment
  • Non-English speaking
  • Women only diagnosed with ductal carcinoma in situ
  • Women diagnosed with stage 4 metastatic breast cancer
  • Pregnant women
  • Men
  • Children
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Kathleen M Sturgeon, PhD 717-531-0003 ext 284676 kms99@psu.edu
Contact: Kathryn H Schmitz, PhD 717-531-4387 kschmitz@phs.psu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03280836
Other Study ID Numbers  ICMJE 5517
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kathleen Sturgeon, Milton S. Hershey Medical Center
Study Sponsor  ICMJE Milton S. Hershey Medical Center
Collaborators  ICMJE NRG Oncology
Investigators  ICMJE
Principal Investigator: Kathleen M Sturgeon, PhD Assistant Professor, Penn State
PRS Account Milton S. Hershey Medical Center
Verification Date December 2019

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