Rowing Following Breast Cancer Chemotherapy
ConditionBreast Cancer Survivors
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-80
SponsorUniversity of Florida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Exercise training
BehavioralThis is a single site center-based supervised exercise intervention.
Treatment groups
72 Participants
are divided into 2 treatment groupsGroup A: Indoor RowingExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in brachial FMD
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.
Time frame
Baseline, Following 12 weeks of supervised exercise training2
Change in global longitudinal strain
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.
Time frame
Baseline, Following 12 weeks of supervised exercise training3
% completed vs. planned exercise frequency
We will collect information throughout the exercise intervention regarding % completed vs. planned exercise sessions/week.
Time frame
Throughout the 12 weeks of supervised exercise training4
% completed vs. planned exercise duration
We will collect information throughout the exercise intervention regarding % completed vs. planned exercise min/session.
Time frame
Throughout the 12 weeks of supervised exercise trainingSponsors and contacts
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Source ClinicalTrials.gov