N/A
N=19
Exercise Program in Breast Cancer Patients Receiving Neoadjuvant Chemotherapy
Breast Neoplasm · Physical Activity
Bottom Line
View on ClinicalTrials.gov: NCT03280836 ↗Enrolled (actual)
19
Serious AEs
52.6%
Results posted
May 2023
Primary outcome: Primary: Acceptability: Percent of Eligible Patients That Provide Consent and Are Enrolled in the Study. — 19 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Exercise (Behavioral)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Milton S. Hershey Medical Center
- Primary completion
- Dec 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Acceptability: Percent of Eligible Patients That Provide Consent and Are Enrolled in the Study. |
19 | — |
| PRIMARY Participant Adherence to the Exercise Intervention |
72.7; 61.0; 23.7 | — |
| PRIMARY Change in Cardiopulmonary Fitness Level From Baseline to the Window Following Chemotherapy Completion and Before Surgical Resection |
-27.5; -1.0 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT03280836). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.