Exercise Program in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy



Status:Recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:21 - Any
Updated:11/30/2018
Start Date:August 3, 2017
End Date:December 31, 2020
Contact:Kathleen M Sturgeon, PhD
Email:kms99@psu.edu
Phone:717-531-0003

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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.

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

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
We found this trial at
2
sites
Hershey, Pennsylvania 17033
Phone: 717-531-0003
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Phone: 215-615-3245
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