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

Primary Purpose

Breast Neoplasm, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Neoplasm

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Penn State Hershey Medical Center
  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Exercise

Arm Description

We ask that participants in the control arm do not start an exercise program.

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.

Outcomes

Primary Outcome Measures

Acceptability: Percent of Eligible Patients That Provide Consent and Are Enrolled in the Study.
Acceptability of the study will be assessed by documenting the percent of eligible patients that provide consent and are enrolled in the study.
Participant Adherence to the Exercise Intervention
Tolerability was defined for each intervention exercise training phase by the percent of weekly exercise minutes completed at the prescribed exercise intensity according to the patient's heart rate monitor.
Change in Cardiopulmonary Fitness Level From Baseline to the Window Following Chemotherapy Completion and Before Surgical Resection
Expired gas analysis (oxygen used by the body) during a submaximal treadmill exercise test determined cardiopulmonary fitness. Change between baseline and the window following chemotherapy completion and before surgical resection, was calculated as the value at the test conducted in the window following chemotherapy completion and before surgical resection minus the value at the test conducted at baseline.

Secondary Outcome Measures

Full Information

First Posted
August 31, 2017
Last Updated
May 25, 2023
Sponsor
Milton S. Hershey Medical Center
Collaborators
NRG Oncology
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1. Study Identification

Unique Protocol Identification Number
NCT03280836
Brief Title
Exercise Program in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
Acronym
WISER-NET
Official Title
Women In Steady Exercise Research - Neoadjuvant Exercise Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
August 3, 2017 (Actual)
Primary Completion Date
December 21, 2020 (Actual)
Study Completion Date
December 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
Collaborators
NRG Oncology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm, Physical Activity

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized to the intervention or control arm.
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
We ask that participants in the control arm do not start an exercise program.
Arm Title
Exercise
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Acceptability: Percent of Eligible Patients That Provide Consent and Are Enrolled in the Study.
Description
Acceptability of the study will be assessed by documenting the percent of eligible patients that provide consent and are enrolled in the study.
Time Frame
4 weeks
Title
Participant Adherence to the Exercise Intervention
Description
Tolerability was defined for each intervention exercise training phase by the percent of weekly exercise minutes completed at the prescribed exercise intensity according to the patient's heart rate monitor.
Time Frame
Introduction phase of prescribed exercise training (weeks 1-4), intermediate phase of prescribed exercise training (weeks 5-11), maintenance phase of prescribed exercise training (weeks 12-chemotherapy completion)
Title
Change in Cardiopulmonary Fitness Level From Baseline to the Window Following Chemotherapy Completion and Before Surgical Resection
Description
Expired gas analysis (oxygen used by the body) during a submaximal treadmill exercise test determined cardiopulmonary fitness. Change between baseline and the window following chemotherapy completion and before surgical resection, was calculated as the value at the test conducted in the window following chemotherapy completion and before surgical resection minus the value at the test conducted at baseline.
Time Frame
Baseline and the window following chemotherapy completion and before surgical resection (no longer than 26 weeks from baseline)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen M Sturgeon, PhD
Organizational Affiliation
Assistant Professor, Penn State
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35216638
Citation
Sturgeon KM, Smith AM, Federici EH, Kodali N, Kessler R, Wyluda E, Cream LV, Ky B, Schmitz KH. Feasibility of a tailored home-based exercise intervention during neoadjuvant chemotherapy in breast cancer patients. BMC Sports Sci Med Rehabil. 2022 Feb 25;14(1):31. doi: 10.1186/s13102-022-00420-6.
Results Reference
result

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Exercise Program in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy

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