Status:
RECRUITING
All-extremity Exercise During Breast Cancer Chemotherapy
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-85 years
Phase:
NA
Brief Summary
Currently, there are 3.5 million breast cancer survivors in the United States and this number is expected to increase dramatically. The proposed research will examine whether a novel exercise interven...
Eligibility Criteria
Inclusion
- Active diagnosis of primary invasive non-metastatic breast cancer, stages I-III
- Female
- 18 to 85 years of age
- Scheduled to initiate neoadjuvant or adjuvant chemotherapy (anthracycline, alkylating agent and/or taxane)
- Absence of contraindications to exercise
- Study clinician approval
- Able to give consent
- Informed consent obtained from the subject and documentation of subject agreement to comply with study-related process
Exclusion
- Do not meet inclusion criteria
- Receiving targeted therapies (CDK4/6 or PARP inhibitors)
- Receiving radiation therapy concurrent with chemotherapy
- Lymphedema stage ≥ 2 prior to study enrollment
- Any relevant cardiovascular diseases (stroke, heart failure, myocardial ischemia during maximal graded exercise test, myocardial infarction, angina pectoris, coronary artery bypass surgery or angioplasty or coronary stent)
- Current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)
Key Trial Info
Start Date :
April 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2027
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT04914663
Start Date
April 5 2024
End Date
January 31 2027
Last Update
October 1 2025
Active Locations (1)
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1
Integrative Cardiovasculal Physiology Laboratory, University of Florida
Gainesville, Florida, United States, 32611