Breast Cancer Survivors
Conditions
Brief summary
There are more than 3.8 million breast cancer survivors in the United States and cancer survivors have a higher risk of cardiovascular disease (CVD) due to chemotherapy than adults without cancer. Cardiovascular rehabilitation can be an effective strategy to decrease the incidence of CVD and its risk factors in this population. The proposed study may help to examine the effect of a novel exercise intervention on cardiovascular rehabilitation in breast cancer survivors.
Interventions
BEHAVIORALExercise training
This is a single site center-based supervised exercise intervention.
Sponsors
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* diagnosis of primary invasive non-metastatic breast cancer, stages I-III * female based on biological sex * 40 to 80 years of age * completed breast cancer treatment 6 to 24 months prior to study enrollment. Adjuvant endocrine therapy for breast cancer (e.g., ovarian suppression, SERMs, SERDs, AIs), CDK4/6 inhibitors, PARP inhibitors, HER2 targeted agents, immunotherapy and bisphosphonates are allowed within 6 months prior to study enrollment and during study participation * absence of contraindications to exercise or study participation * study clinician approval
Exclusion criteria
* do not meet inclusion criteria * receiving or scheduled to receive treatment for breast cancer (i.e., chemotherapy, surgery, or radiation) during study participation is not allowed. Adjuvant endocrine therapy, CDK4/6 inhibitors, PARP inhibitors, HER2 targeted agents, immunotherapy and bisphosphonates are allowed during study participation * lymphedema stage ≥ 2 prior to study enrolment * 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) * consistent participation in ≥150 min/week of moderate-intensity rowing exercise training in previous 6 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % completed vs. planned exercise intensity | Throughout the 12 weeks of supervised exercise training | We will collect information throughout the exercise intervention regarding % completed vs. planned exercise intensity/session. |
| % completed vs. planned exercise duration | Throughout the 12 weeks of supervised exercise training | We will collect information throughout the exercise intervention regarding % completed vs. planned exercise min/session. |
| Change in brachial FMD | Baseline, Following 12 weeks of supervised exercise training | Flow-mediated dilation (FMD) is an established non-invasive measure of endothelial function. Brachial artery FMD will be determined via ultrasonography in response to reactive hyperemia following 5-min forearm ischemia. |
| Change in global longitudinal strain | Baseline, Following 12 weeks of supervised exercise training | Global longitudinal strain is a marker of acute subclinical cardiotoxicity and is recommended for monitoring cancer patients at risk of cancer therapy-related cardiac dysfunction. |
| % completed vs. planned exercise frequency | Throughout the 12 weeks of supervised exercise training | We will collect information throughout the exercise intervention regarding % completed vs. planned exercise sessions/week. |
| Number of participants who experience adverse event as defined by most recent CTCAE | Throughout the 12 weeks of supervised exercise training | To evaluate safety plans are in place for determination and monitoring of adverse events according to the most recent National Cancer Institute Common Terminology Criteria for Adverse Events. Classification for seriousness, expectedness, severity and relationship to study intervention will be based on the NIH provided definitions. |
Countries
United States
Contacts
CONTACTDemetra Christou, PhD
PRINCIPAL_INVESTIGATORDemetra Christou, PhD
University of Florida
Outcome results
None listed