Rowing Following Breast Cancer Chemotherapy

University of Florida72 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Breast Cancer Survivors

Interventions

Exercise trainingBEHAVIORAL

This is a single site center-based supervised exercise intervention.

Eligibility

Sex: FEMALEMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Integrative Cardiovasculal Physiology Laboratory, University of Florida

Gainesville, Florida, United States

RECRUITING

Outcomes

Primary Outcomes

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 training

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 training

% 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 training

% 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 training

% completed vs. planned exercise intensity

We will collect information throughout the exercise intervention regarding % completed vs. planned exercise intensity/session.

Time frame: Throughout the 12 weeks of supervised exercise training

Number of participants who experience adverse event as defined by most recent CTCAE

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.

Central Contacts

Demetra Christou, PhD

CONTACT

352-294-1746 ddchristou@ufl.edu

Data from ClinicalTrials.gov

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