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All-extremity Exercise During Breast Cancer Chemotherapy

Primary Purpose

Breast Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise training
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Breast Cancer

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • active diagnosis of primary invasive non-metastatic breast cancer, hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2-) subtype, stages I-III
  • female
  • 50 years of age or older
  • postmenopausal at time of breast cancer diagnosis as determined by their medical oncologist
  • scheduled to initiate neoadjuvant or adjuvant chemotherapy (anthracycline, alkylating agent and/or taxane)
  • absence of contraindications to exercise
  • medical oncologist approval
  • able to give consent
  • informed consent obtained from the subject and documentation of subject agreement to comply with study-related process

Exclusion Criteria:

  • do not meet inclusion criteria
  • receiving targeted therapies (HER2, CDK4/6 or PPAR inhibitors)
  • receiving radiation therapy concurrent with chemotherapy
  • 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)
  • current participation in aerobic exercise training

Sites / Locations

  • Integrative Cardiovasculal Physiology Laboratory, University of FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

All-extremity exercise

Treadmill exercise

Usual Care

Arm Description

Outcomes

Primary Outcome Measures

Change in brachial artery 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.
Feasibility, tolerability and safety of exercise training during breast cancer chemotherapy
To evaluate the feasibility, tolerability and safety of all-extremity exercise compared with treadmill exercise in breast cancer patients undergoing chemotherapy, we will collect comprehensive information throughout the exercise intervention: completed vs. planned exercise dose (intensity/session, min/session, sessions/week), reasons for missed/partially completed sessions or study withdrawal, adverse events, and disease- and treatment-related outcomes. To specifically evaluate safety, should an adverse event occur, plans are in place for determination and monitoring 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

First Posted
May 28, 2021
Last Updated
October 20, 2023
Sponsor
University of Florida
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT04914663
Brief Title
All-extremity Exercise During Breast Cancer Chemotherapy
Official Title
All-extremity Exercise as a Novel Strategy for Optimizing Cardiovascular Function During Chemotherapy for Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

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
Currently, there are 3.5 million breast cancer survivors in the United States and this number is expected to increase dramatically. The proposed research will examine whether a novel exercise intervention for breast cancer patients who are undergoing chemotherapy protects against cardiovascular dysfunction. Findings may have implications for cardiovascular disease prevention in this population.

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
68 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All-extremity exercise
Arm Type
Experimental
Arm Title
Treadmill exercise
Arm Type
Active Comparator
Arm Title
Usual Care
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Exercise training
Intervention Description
Exercise training performed at home under remote live supervision over 12 weeks while patients undergo chemotherapy for breast cancer.
Primary Outcome Measure Information:
Title
Change in brachial artery 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
12 weeks
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
12 weeks
Title
Feasibility, tolerability and safety of exercise training during breast cancer chemotherapy
Description
To evaluate the feasibility, tolerability and safety of all-extremity exercise compared with treadmill exercise in breast cancer patients undergoing chemotherapy, we will collect comprehensive information throughout the exercise intervention: completed vs. planned exercise dose (intensity/session, min/session, sessions/week), reasons for missed/partially completed sessions or study withdrawal, adverse events, and disease- and treatment-related outcomes. To specifically evaluate safety, should an adverse event occur, plans are in place for determination and monitoring 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
Monitored throughout the 12 weeks of intervention

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Women who will receive 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: Active diagnosis of primary invasive non-metastatic breast cancer, stages I-III Female 18 to 85 years of age Scheduled to initiate neoadjuvant or adjuvant chemotherapy (anthracycline, alkylating agent and/or taxane) Absence of contraindications to exercise Study clinician approval Able to give consent Informed consent obtained from the subject and documentation of subject agreement to comply with study-related process Exclusion Criteria: Do not meet inclusion criteria Receiving targeted therapies (CDK4/6 or PARP inhibitors) Receiving radiation therapy concurrent with chemotherapy 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) Current participation in other experimental interventions that may confound interpretation of study findings (e.g., dietary intervention for weight loss) Current participation in aerobic exercise training (≥150 min/week of moderate-intensity aerobic exercise)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Demetra Christou, PhD
Phone
3522941746
Email
ddchristou@ufl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Eileen Handberg
Phone
352-273-9082
Email
handbem@medicine.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
Individual Site Status
Recruiting
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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All-extremity Exercise During Breast Cancer Chemotherapy

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