All-extremity Exercise During Breast Cancer Chemotherapy
Recruiting · NCT04914663 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Florida
View the official record on ClinicalTrials.gov →Interventions studied
Exercise training
What this trial is about
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 intervention for breast cancer patients who are undergoing chemotherapy protects against cardiovascular dysfunction. Findings may have implications for cardiovascular disease prevention in this population.
Who can take part
Age range
18 Years to 85 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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)
Where it is running
1 location listed across 1 US state.
- Integrative Cardiovasculal Physiology Laboratory, University of Florida - Gainesville, Florida, United States