Back to resultsHIIT Following Breast Cancer Chemotherapy
Primary Purpose
Breast Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
12-week Intervention Period
12-week Observation Period
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer
Eligibility Criteria
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 12 months prior to study enrollment absence of contraindications to exercise or to participate in study study clinician approval Exclusion Criteria: do not meet inclusion criteria completed chemotherapy and/or other cancer treatment (e.g., surgery or radiation) besides ovarian suppression within 6 months of study enrollment scheduled to receive surgery, radiation therapy or other cancer treatment besides ovarian suppression during the study period 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) are pregnant current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss) consistent participation over the past 6 months in moderate-intensity aerobic exercise training for ≥150 min/week
Sites / Locations
- Integrative Cardiovascular Physiology Laboratory, University of Florida
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
High Intensity Interval Training (HIIT)
Moderate Intensity Continuous Training (MICT)
Usual Care (UC)
Arm Description
Supervised home-based high-intensity interval training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks.
Supervised home-based moderate-intensity continuous training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks.
Research participants will continue their habitual physical activity for the duration of the study. Once they complete the study, they will have the opportunity to perform supervised HIIT or MICT at home for 3 days/week for 12 weeks (research participants can choose either type of exercise).
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 cardiac function (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.
Percent completed vs. planned exercise frequency
The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise sessions/week.
Percent completed vs. planned exercise duration
The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise min/session.
Percent completed vs. planned exercise intensity
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
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
NCT ID
NCT05913713
First Posted
June 13, 2023
Last Updated
October 20, 2023
Sponsor
University of Florida
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05913713
Brief Title
HIIT Following Breast Cancer Chemotherapy
Official Title
High Intensity Interval Training: Optimizing Exercise Therapy to Mitigate Cardiovascular Disease Risk Following Breast Cancer 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 25, 2025 (Anticipated)
Study Completion Date
May 25, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute on Aging (NIA)
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
158 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High Intensity Interval Training (HIIT)
Arm Type
Experimental
Arm Description
Supervised home-based high-intensity interval training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks.
Arm Title
Moderate Intensity Continuous Training (MICT)
Arm Type
Experimental
Arm Description
Supervised home-based moderate-intensity continuous training will be performed on an all-extremity stationary cycle 3 days/week for 12 weeks.
Arm Title
Usual Care (UC)
Arm Type
Other
Arm Description
Research participants will continue their habitual physical activity for the duration of the study. Once they complete the study, they will have the opportunity to perform supervised HIIT or MICT at home for 3 days/week for 12 weeks (research participants can choose either type of exercise).
Intervention Type
Behavioral
Intervention Name(s)
12-week Intervention Period
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
12-week Observation Period
Intervention Description
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.
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 a 12-week intervention period, Following a 12-week observation period
Title
Change in cardiac function (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 a 12-week intervention period, Following a 12-week observation period
Title
Percent completed vs. planned exercise frequency
Description
The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise sessions/week.
Time Frame
Throughout the 12 weeks of supervised home-based exercise training
Title
Percent completed vs. planned exercise duration
Description
The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise min/session.
Time Frame
Throughout the 12 weeks of supervised home-based exercise training
Title
Percent completed vs. planned exercise intensity
Description
The investigators will collect information throughout the exercise intervention regarding % completed vs. planned exercise intensity/session.
Time Frame
Throughout the 12 weeks of supervised home-based exercise training
Title
Number of participants who experience adverse events as defined by most recent CTCAE throughout the exercise intervention
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 home-based exercise training
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women who received chemotherapy for breast cancer
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 12 months prior to study enrollment
absence of contraindications to exercise or to participate in study
study clinician approval
Exclusion Criteria:
do not meet inclusion criteria
completed chemotherapy and/or other cancer treatment (e.g., surgery or radiation) besides ovarian suppression within 6 months of study enrollment
scheduled to receive surgery, radiation therapy or other cancer treatment besides ovarian suppression during the study period
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)
are pregnant
current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss)
consistent participation over the past 6 months in moderate-intensity aerobic exercise training for ≥150 min/week
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 Cardiovascular 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
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HIIT Following Breast Cancer Chemotherapy
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