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

Women In Steady Exercise Research - Neoadjuvant Exercise Trial

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.

Study Overview

• Status: Completed
• Conditions: Physical Activity; Breast Neoplasm
• Intervention / Treatment: Behavioral: Exercise

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: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Penn State Hershey Medical Center
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 weeks
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.	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)
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.	Baseline and the window following chemotherapy completion and before surgical resection (no longer than 26 weeks from baseline)

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: NRG Oncology
• Investigators: Principal Investigator: Kathleen M Sturgeon, PhD, Assistant Professor, Penn State

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): August 3, 2017
• Primary Completion (Actual): December 21, 2020
• Study Completion (Actual): December 21, 2020

Study Registration Dates

• First Submitted: August 31, 2017
• First Submitted That Met QC Criteria: September 11, 2017
• First Posted (Actual): September 13, 2017

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 1, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 5517

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No