Back to resultsRowing Following Breast Cancer Chemotherapy
Primary Purpose
Breast Cancer Survivors
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise training
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer Survivors
Eligibility Criteria
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 chemotherapy 6 to 18 months prior to study enrollment absence of contraindications to exercise or study participation study clinician approval Exclusion Criteria: do not meet inclusion criteria completed chemotherapy and/or other cancer treatment within past 6 months (e.g., surgery or radiation). Ovarian suppression within past 6 months is allowed. receiving or scheduled to receive radiation therapy during study participation scheduled to receive surgery during study participation receiving or scheduled to receive other cancer treatment besides ovarian suppression during study participation 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) body mass index ≥ 40 kg/m2 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 aerobic exercise training in previous 6 months
Sites / Locations
- Integrative Cardiovasculal Physiology Laboratory, University of Florida
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Indoor Rowing
Usual Care
Arm Description
Research participants will be instructed how to use a Concept 2 RowErg and will be provided instruction on basic rowing skills for beginners. Exercise training will gradually progress to 50 min of moderate-intensity exercise, on 3 days per week, for 12 weeks.
Research participants in this group will have the opportunity to complete the supervised indoor rowing program after completing their post-intervention assessments.
Outcomes
Primary Outcome Measures
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.
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.
% completed vs. planned exercise frequency
We will collect information throughout the exercise intervention regarding % completed vs. planned exercise sessions/week.
% completed vs. planned exercise duration
We will collect information throughout the exercise intervention regarding % completed vs. planned exercise min/session.
% completed vs. planned exercise intensity
We will collect information throughout the exercise intervention regarding % completed vs. planned exercise intensity/session.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05848141
Brief Title
Rowing Following Breast Cancer Chemotherapy
Official Title
Indoor Rowing as a Novel Exercise Therapy for Cardiovascular Rehabilitation in Middle-Aged and Older Breast Cancer Survivors Following Chemotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer Survivors
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Indoor Rowing
Arm Type
Experimental
Arm Description
Research participants will be instructed how to use a Concept 2 RowErg and will be provided instruction on basic rowing skills for beginners. Exercise training will gradually progress to 50 min of moderate-intensity exercise, on 3 days per week, for 12 weeks.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Research participants in this group will have the opportunity to complete the supervised indoor rowing program after completing their post-intervention assessments.
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
This is a single site center-based supervised exercise intervention.
Primary Outcome Measure Information:
Title
Change in brachial FMD
Description
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
Title
Change in global longitudinal strain
Description
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
Title
% completed vs. planned exercise frequency
Description
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
Title
% completed vs. planned exercise duration
Description
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
Title
% completed vs. planned exercise intensity
Description
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
Title
Number of participants who experience adverse event as defined by most recent CTCAE
Description
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.
Time Frame
Throughout the 12 weeks of supervised exercise training
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 chemotherapy 6 to 18 months prior to study enrollment
absence of contraindications to exercise or study participation
study clinician approval
Exclusion Criteria:
do not meet inclusion criteria
completed chemotherapy and/or other cancer treatment within past 6 months (e.g., surgery or radiation). Ovarian suppression within past 6 months is allowed.
receiving or scheduled to receive radiation therapy during study participation
scheduled to receive surgery during study participation
receiving or scheduled to receive other cancer treatment besides ovarian suppression during study participation
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)
body mass index ≥ 40 kg/m2
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 aerobic exercise training in previous 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Demetra Christou, PhD
Phone
352-294-1746
Email
ddchristou@ufl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Demetra Christou, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Integrative Cardiovasculal Physiology Laboratory, University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Demetra Christou, PhD
Phone
352-294-1746
Email
ddchristou@ufl.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Rowing Following Breast Cancer Chemotherapy
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