Status:
COMPLETED
Exercise Program in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
Lead Sponsor:
Milton S. Hershey Medical Center
Collaborating Sponsors:
NRG Oncology
Conditions:
Breast Neoplasm
Physical Activity
Eligibility:
FEMALE
21+ years
Phase:
NA
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 brea...
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 p...
Eligibility Criteria
Inclusion
- 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
- 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
Exclusion
Key Trial Info
Start Date :
August 3 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 21 2020
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03280836
Start Date
August 3 2017
End Date
December 21 2020
Last Update
December 5 2023
Active Locations (2)
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1
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
2
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104