Back to resultsExercise in Metastatic Breast Cancer: EMBody
Primary Purpose
Breast Cancer, Indolent Metastatic Breast Cancer
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Exercise Intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring breast cancer, indolent metastatic breast cancer, exercise
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Diagnosis of metastatic breast cancer
No progression of disease in the 12 months prior to screening per the treating investigator
- If participant has changed treatments in the prior 12 months for reasons other than progressive disease, they remain eligible
- Participants on no treatment or "no evidence of disease" but still with a diagnosis of metastatic breast cancer are eligible
- ECOG performance status of 0-2
- Participants must be able to march in place for 30 seconds. Assistance by holding onto a chair is allowed.
- Informed consent and authorization of the release of health information must be obtained according to institutional guidelines
- Currently not meeting physical activity guidelines (defined as less than 150 minutes of moderate to vigorous exercise per week measured by the RPAQ questionnaire administered during screening)
Exclusion Criteria:
Receiving cytotoxic chemotherapy at any point in the prior 12 months.
- Participants receiving endocrine therapy are eligible.
- Participants receiving targeted therapy or antibody therapy are eligible (examples including trastuzumab, pertuzumab, TDM-1, trastuzumab deruxtecan, sacituzumab govetecan, immunotherapy, CDK4/6 inhibitors, olaparib, alpelisib, etc.)
Any condition precluding supervised exercise participation. A letter from a physician supporting participation can supercede this eligibility criteria.
- NYHA class III or IV congestive heart failure
- Uncontrolled angina
- Myocardial infarction in the prior 12 months
- Orthopedic surgery in the previous 3 months or plans for orthopedic surgery during the study period
- Chronic uncontrolled pulmonary conditions such as uncontrolled asthma (symptoms > 2 days/week) or dyspnea requiring oxygen
- Symptomatic peripheral vascular disease
- Or any other comorbidity that would interfere with the ability to complete and comply with the protocol in the opinion of the investigator, including psychological illness.
- Active, untreated brain metastases
Sites / Locations
- IU Health WestRecruiting
- IU Health Joe and Shelly Schwarz Cancer CenterRecruiting
- Indiana University Melvin & Bren Simon Cancer CenterRecruiting
- Sidney and Lois Eskenazi HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise Intervention
Usual Care
Arm Description
Eligible and consented participants randomized to the exercise arm (EX) will work with an exercise trainer 3x weekly for 16 weeks. Training sessions are 60 min. Schedules are determined by participant and trainer with oversight by the study team, ideally occurring at similar times each day in line with IBC theory. Each training session will be delivered virtually over a HIPAA compliant IU Health Zoom platform. The virtual exercise sessions include 3 parts: cardiovascular exercise, resistance training, and balance or stretching exercise. During sessions, patients will wear provided heart rate monitors with a training goal of moderate intensity, defined as 40-60% of heart rate reserve. Based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session, trainers will follow an algorithm designed by the PI and collaborators to progress or regress intensity level. Participant will attend a class on creating and maintaining behavior changes.
Participants randomized to usual care (UC) will receive care per their treatment team. UC participants are encouraged to exercise but will not be provided components of the intervention. Participants in the UC arm will be given usual care handouts at baseline from the American College of Sports Medicine.
Outcomes
Primary Outcome Measures
Change in cardiorespiratory fitness
Measured by minutes on the treadmill
Secondary Outcome Measures
physical performance battery
total score on short physical performance battery
Mean quality of life, as measured by the Patient-Reported Outcomes Measurement Information System-29
Likert-scaled questionnaire, with response scores ranging from 1 to 5. Scores alternate from 1 or 5 being the lowest value.
muscle mass
measured by mg/kg2 on HU on CT scans
muscle density
measured by mg/kg2 on HU on CT scans
adipose mass
measured by mg/kg2 on HU on CT scans
Change in physical activity minutes
measured by accelerometer data
Change in steps per day
measured by accelerometer data
Mean fatigue score as measured by the basic fatigue inventory (BFI)
Likert-scaled questionnaire, with response scores ranging from 0 to 10, with 10 being the worse response.
Change intention and habits, as measured by the Behavioral Theory Scales
Likert-scaled questionnaire, measured with a 5-point Likert scale with response options ranging from "strongly disagree" to "strongly agree." Total scores are summed in the range of 40 to 200, with a higher score indicating stronger motivation that could predict exercise behavior.
Uptake of the study
the proportion of total patients approached, screened, and ultimately completing the baseline assessments
Adherence with the intervention defined
the proportion of scheduled sessions attended by participants randomized to the exercise intervention arm
change in patient-reported functional limitations, as measured by a functional limitations scale
mean score of 5 question scale, where participants responses are either scored 0 or 1, with "some difficulty" a 1 and "no difficulty" as a 0.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05468034
Brief Title
Exercise in Metastatic Breast Cancer: EMBody
Official Title
Exercise in Metastatic Breast Cancer: EMBody
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 26, 2023 (Actual)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
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
The purpose of this study is to study exercise in a novel population with indolent MBC (no progression on current therapy in prior 12 months and not receiving cytotoxic chemotherapy). The study team hypothesizes that delivering virtual, supervised, progressive intensity aerobic and resistance training exercise for 16 weeks in this population will significantly improve 1) cardiorespiratory fitness, functional status, and sarcopenia (low muscle mass), all established predictors of survival, and 2) patient- reported outcomes.
Detailed Description
This is a randomized, two arm, single-center study designed to compare the effect of exercise versus usual care control on the clinical parameter of cardiorespiratory fitness, in patients with metastatic breast cancer with indolent disease biology over a 16-week period. This study will be enrolling up to 100 participants. Participants will be randomized 1:1 in blocks of 4 to the exercise intervention or usual care, stratified by frailty yes/no defined by baseline SPPB score ≤ 8 or > 8.
Primary Objective To compare the effect of a 16-week multimodality, virtually delivered exercise intervention on cardiorespiratory fitness measured by a modified Bruce ramp protocol treadmill test to usual care, in patients with indolent metastatic breast cancer.
Secondary Objectives
To compare the effect of exercise versus usual care on objective physical function measured by the short physical performance battery (SBBP)
To compare the effect of exercise versus usual care on subjective physical functioning measured by PROMIS-29 questionnaire
To compare the effect of exercise versus usual care on body composition, measured by visceral adiposity, lean muscle mass, and muscle density on CT scans obtained as standard of care using SliceOmatic software
To compare the effect of exercise versus usual care on objective physical activity measured by accelerometer wear
To compare the effect of exercise versus usual care on patient reported outcomes, including fatigue (BFI) and health related quality of life (PROMIS-29)
To determine the fidelity of the exercise intervention, measured by changes in measures of constructs of habit and intention administered by questionnaire
To describe patient uptake and adherence with the intervention, measured by proportion of approached patients who consent to the study, and proportion of assigned training sessions attended by patients randomized to the exercise arm.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Indolent Metastatic Breast Cancer
Keywords
breast cancer, indolent metastatic breast cancer, exercise
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise Intervention
Arm Type
Experimental
Arm Description
Eligible and consented participants randomized to the exercise arm (EX) will work with an exercise trainer 3x weekly for 16 weeks. Training sessions are 60 min. Schedules are determined by participant and trainer with oversight by the study team, ideally occurring at similar times each day in line with IBC theory. Each training session will be delivered virtually over a HIPAA compliant IU Health Zoom platform. The virtual exercise sessions include 3 parts: cardiovascular exercise, resistance training, and balance or stretching exercise. During sessions, patients will wear provided heart rate monitors with a training goal of moderate intensity, defined as 40-60% of heart rate reserve. Based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session, trainers will follow an algorithm designed by the PI and collaborators to progress or regress intensity level. Participant will attend a class on creating and maintaining behavior changes.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants randomized to usual care (UC) will receive care per their treatment team. UC participants are encouraged to exercise but will not be provided components of the intervention. Participants in the UC arm will be given usual care handouts at baseline from the American College of Sports Medicine.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Intervention
Intervention Description
Eligible and consented participants randomized to the exercise arm (EX) will work with an exercise trainer 3x weekly for 16 weeks. Training sessions are 60 min. Schedules are determined by participant and trainer with oversight by the study team, ideally occurring at similar times each day in line with IBC theory. Each training session will be delivered virtually over a HIPAA compliant IU Health Zoom platform. The virtual exercise sessions include 3 parts: cardiovascular exercise, resistance training, and balance or stretching exercise. During sessions, patients will wear provided heart rate monitors with a training goal of moderate intensity, defined as 40-60% of heart rate reserve. Based on the participant's rate of perceived exertion (RPE), heart rate, and individual response during each session, trainers will follow an algorithm designed by the PI and collaborators to progress or regress intensity level. Participant will attend a class on creating and maintaining behavior changes.
Primary Outcome Measure Information:
Title
Change in cardiorespiratory fitness
Description
Measured by minutes on the treadmill
Time Frame
baseline, 16 weeks
Secondary Outcome Measure Information:
Title
physical performance battery
Description
total score on short physical performance battery
Time Frame
baseline, 8, and 16 weeks
Title
Mean quality of life, as measured by the Patient-Reported Outcomes Measurement Information System-29
Description
Likert-scaled questionnaire, with response scores ranging from 1 to 5. Scores alternate from 1 or 5 being the lowest value.
Time Frame
baseline, 8, and 16 weeks
Title
muscle mass
Description
measured by mg/kg2 on HU on CT scans
Time Frame
baseline, and 16 weeks
Title
muscle density
Description
measured by mg/kg2 on HU on CT scans
Time Frame
baseline, and 16 weeks
Title
adipose mass
Description
measured by mg/kg2 on HU on CT scans
Time Frame
baseline, and 16 weeks
Title
Change in physical activity minutes
Description
measured by accelerometer data
Time Frame
baseline to post 16-week intervention
Title
Change in steps per day
Description
measured by accelerometer data
Time Frame
baseline to post 16-week intervention
Title
Mean fatigue score as measured by the basic fatigue inventory (BFI)
Description
Likert-scaled questionnaire, with response scores ranging from 0 to 10, with 10 being the worse response.
Time Frame
baseline, and16-weeks
Title
Change intention and habits, as measured by the Behavioral Theory Scales
Description
Likert-scaled questionnaire, measured with a 5-point Likert scale with response options ranging from "strongly disagree" to "strongly agree." Total scores are summed in the range of 40 to 200, with a higher score indicating stronger motivation that could predict exercise behavior.
Time Frame
baseline, and 16-weeks
Title
Uptake of the study
Description
the proportion of total patients approached, screened, and ultimately completing the baseline assessments
Time Frame
date open to accrual until closed to accrual, up to 5 years
Title
Adherence with the intervention defined
Description
the proportion of scheduled sessions attended by participants randomized to the exercise intervention arm
Time Frame
baseline to post 16-week intervention
Title
change in patient-reported functional limitations, as measured by a functional limitations scale
Description
mean score of 5 question scale, where participants responses are either scored 0 or 1, with "some difficulty" a 1 and "no difficulty" as a 0.
Time Frame
baseline, and16-weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Diagnosis of metastatic breast cancer
No progression of disease in the 12 months prior to screening per the treating investigator
If participant has changed treatments in the prior 12 months for reasons other than progressive disease, they remain eligible
Participants on no treatment or "no evidence of disease" but still with a diagnosis of metastatic breast cancer are eligible
ECOG performance status of 0-2
Participants must be able to march in place for 30 seconds. Assistance by holding onto a chair is allowed.
Informed consent and authorization of the release of health information must be obtained according to institutional guidelines
Currently not meeting physical activity guidelines (defined as less than 150 minutes of moderate to vigorous exercise per week measured by the RPAQ questionnaire administered during screening)
Exclusion Criteria:
Receiving cytotoxic chemotherapy at any point in the prior 12 months.
Participants receiving endocrine therapy are eligible.
Participants receiving targeted therapy or antibody therapy are eligible (examples including trastuzumab, pertuzumab, TDM-1, trastuzumab deruxtecan, sacituzumab govetecan, immunotherapy, CDK4/6 inhibitors, olaparib, alpelisib, etc.)
Any condition precluding supervised exercise participation. A letter from a physician supporting participation can supercede this eligibility criteria.
NYHA class III or IV congestive heart failure
Uncontrolled angina
Myocardial infarction in the prior 12 months
Orthopedic surgery in the previous 3 months or plans for orthopedic surgery during the study period
Chronic uncontrolled pulmonary conditions such as uncontrolled asthma (symptoms > 2 days/week) or dyspnea requiring oxygen
Symptomatic peripheral vascular disease
Or any other comorbidity that would interfere with the ability to complete and comply with the protocol in the opinion of the investigator, including psychological illness.
Active, untreated brain metastases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jackson Richey
Phone
317-274-0922
Email
jaerich@iupui.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Tarah Ballinger, MD
Email
tarab@iu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarah Ballinger, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
IU Health West
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jackson Richey
Phone
317-274-0922
Email
jaerich@iupui.edu
Facility Name
IU Health Joe and Shelly Schwarz Cancer Center
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jackson Richey
Phone
317-274-0922
Email
jaerich@iupui.edu
Facility Name
Indiana University Melvin & Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jackson Richey
Phone
317-274-0922
Email
jaerich@iupui.edu
First Name & Middle Initial & Last Name & Degree
Tarah Ballinger, MD
Facility Name
Sidney and Lois Eskenazi Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jackson Richey
Phone
317-274-0922
Email
jaerich@iupui.edu
12. IPD Sharing Statement
Learn more about this trial
Exercise in Metastatic Breast Cancer: EMBody
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