Breast Cancer
Conditions
Brief summary
Chemotherapy is an effective breast cancer treatment, which helped to increase the 5-year survival rate to approximately 95%. However, breast 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 and durability of a novel high-intensity interval training compared to moderate-intensity continuous training on cardiovascular rehabilitation in breast cancer survivors.
Interventions
BEHAVIORAL12-week Intervention Period
Research participants will be randomly assigned to either high-intensity interval training (HIIT), moderate-intensity continuous training (MICT), or the usual care (UC) group for a 12-week intervention period.
BEHAVIORAL12-week Observation Period
After a 12-week intervention period (HIIT, MICT, or UC), research participants will have a 12-week observation period to assess the durability of two types of different exercises.
Sponsors
University of Florida
National Institute on Aging (NIA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* female patients based on biological sex * 18 to 85 years of age * diagnosis of primary, invasive, non-metastatic, stages I-III breast cancer * completed chemotherapy for breast cancer (anthracycline, alkylating agent and/or taxane) more than 6 months but less than 18 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 of study enrollment and during study participation * absence of contraindications to exercise or to participate in study * study clinician approval
Exclusion criteria
* do not meet inclusion criteria * scheduled to receive surgery or radiation therapy during the intervention period * 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) * lymphedema stage ≥2 prior to study enrollment * are pregnant * current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in brachial FMD | Baseline, Following a 12-week intervention period, Following a 12-week observation period | 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 cardiac function (global longitudinal strain) | Baseline, Following a 12-week intervention period, Following a 12-week observation period | 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. |
| Percent completed vs. planned exercise frequency | Throughout the 12 weeks of supervised home-based exercise training | The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise sessions/week. |
| Percent completed vs. planned exercise duration | Throughout the 12 weeks of supervised home-based exercise training | The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise min/session. |
| Percent completed vs. planned exercise intensity | Throughout the 12 weeks of supervised home-based exercise training | The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise intensity/session. |
| Number of participants who experience adverse events as defined by most recent CTCAE throughout the exercise intervention | Throughout the 12 weeks of supervised home-based 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
PRINCIPAL_INVESTIGATORDemetra Christou, PhD
University of Florida
Outcome results
None listed