Back to resultsUnderstanding and Predicting Breast Cancer Events After Treatment (UPBEAT)
Primary Purpose
Breast Cancer
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac MRI
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring Breast Cancer, Fatigue, Cardiovascular Events
Eligibility Criteria
Inclusion Criteria for Women with Stage I - III Breast Cancer:
- Stage I-III female breast cancer (including inflammatory and newly diagnosed or locally recurrent breast cancer) but not metastatic breast cancer being treated with curative intent
- > 18 years old
- Scheduled to receive chemotherapy and/or estrogen antagonist aromatase inhibitors (anastrozole [Arimidex], letrozole [Femara], exemestane [Aromasin]).
- Able to hold breath for 10 seconds
- ECOG performance status 0 -2
- Able to walk at least 2 blocks without chest pain, dyspnea, shortness of breath or fainting
- Able to exercise on a treadmill or stationary cycle
- Participants in other ongoing clinical trials are eligible for this study
Exclusion Criteria for Women with Stage I-III Breast Cancer:
- Those with ferromagnetic cerebral aneurysm clips or other intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices (patients with tissue expanders will not be excluded)
- If previously measured, known LVEF <50%
- Symptomatic claustrophobia
- Unable to provide informed consent
- At the beginning of the study, pregnant women and women who are breast-feeding will not be enrolled.
- Severe pulmonary hypertension
Within the past 6 months:
- Acute pulmonary embolus
- Deep vein thrombosis
Within the past month:
- Heart attack
- Unstable or stable angina (cardiac chest pain)
- Left main coronary artery disease
- Symptomatic heart failure
- Uncontrolled hypertension (SBP > 180 mm Hg or DBP > 120 mm Hg)
- Severe valvular heart disease
- Uncontrolled metabolic disease (diabetes with fasting BS >300 mg/dl, thyrotoxicosis, myxedema)
- Aortic aneurism (>45 mm diameter) or aortic dissection
- Uncontrolled slow or fast heart rhythm causing symptoms or hemodynamic compromise
- Hypertrophic obstructive cardiomyopathy
- Patient does not understand English
Inclusion Criteria for Women Free of Cancer for Comparison:
- Healthy female without known coronary artery disease > 18 years old
- Able to hold breath 10 seconds
- ECOG performance status = 0 or 1
- Able to walk at least 2 blocks without chest pain, dyspnea, shortness of breath or fainting
- Able to exercise on a treadmill or stationary cycle
- No personal history of cancer other than superficial skin cancers
- Has never received chemotherapy, radiation therapy, immunotherapy, or had breast cancer related surgery
- If previously measured, LVEF ≥ 50%
Exclusion Criteria for Women Free of Cancer for Comparison:
- Inflammatory conditions such as lupus or inflammatory bowel disease
- Overt coronary artery disease or heart failure
- Those with ferromagnetic cerebral aneurysm clips or other intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices
- Symptomatic claustrophobia
- Unable to provide informed consent
- At the beginning of the study, pregnant women or women who are breast feeding will not be enrolled.
- Severe pulmonary hypertension
Within the past 6 months:
- Acute pulmonary embolus
- Deep vein thrombosis
Within the past month:
- Heart attack
- Unstable or stable angina (cardiac chest pain)
- Left main coronary artery disease
- Symptomatic heart failure
- Uncontrolled hypertension (SBP > 180 mm Hg or DBP > 120 mm Hg)
- Severe valvular heart disease
- Uncontrolled metabolic disease (diabetes with fasting BS >300 mg/dl, thyrotoxicosis, myxedema)
- Aortic aneurism (>45 mm diameter) or aortic dissection
- Uncontrolled slow or fast heart rhythm causing symptoms or hemodynamic compromise
- Hypertrophic obstructive cardiomyopathy
- Patient does not understand English
Sites / Locations
- University of Alabama at Birmingham Cancer Center
- MedStar Washington Hospital Center
- Moffitt Cancer Center - McKinley Campus
- Moffitt Cancer Center
- Northwestern University
- IU Health North Hospital
- Indiana University/Melvin and Bren Simon Cancer Center
- Springmill Medical Center
- University of Kansas Cancer Center
- University of Kansas Hospital-Westwood Cancer Center
- Tufts Medical Center
- University of Michigan Comprehensive Cancer Center
- Beaumont Hospital - Dearborn
- Beaumont Hospital - Farmington Hills
- Spectrum Health at Butterworth Campus
- William Beaumont Hospital-Royal Oak
- William Beaumont Hospital - Troy
- Saint John's Hospital - Healtheast
- Abbott-Northwestern Hospital
- Health Partners Inc
- Regions Hospital
- United Hospital
- Minnesota Oncology Hematology PA-Woodbury
- Morristown Medical Center
- Newton Medical Center
- Overlook Hospital
- Randolph Hospital
- Cone Health Cancer Center at Alamance Regional
- Novant Health Presbyterian Medical Center
- Duke University Medical Center
- Cone Health Cancer Center
- Wake Forest University Health Sciences
- UPMC Pinnacle Cancer Center/Community Osteopathic Campus
- University of Pennsylvania/Abramson Cancer Center
- UPMC Memorial
- Prisma Health Cancer Institute - Spartanburg
- Prisma Health Cancer Institute - Easley
- Prisma Health Cancer Institute - Butternut
- Prisma Health Cancer Institute - Faris
- Prisma Health Greenville Memorial Hospital
- Prisma Health Cancer Institute - Eastside
- Prisma Health Cancer Institute - Greer
- Prisma Health Cancer Institute - Seneca
- UT Southwestern/Simmons Cancer Center-Dallas
- Centra Lynchburg Hematology-Oncology Clinic Inc
- Virginia Cancer Institute
- VCU Massey Cancer Center at Stony Point
- Virginia Commonwealth University/Massey Cancer Center
- Shenandoah Oncology PC
- University of Washington Medical Center - Montlake
- Aurora Cancer Care-Southern Lakes VLCC
- Aurora Health Center-Fond du Lac
- Aurora Health Care Germantown Health Center
- Aurora Cancer Care-Grafton
- Aurora BayCare Medical Center
- Aurora Cancer Care-Kenosha South
- Aurora Cancer Care-Milwaukee
- Aurora Saint Luke's Medical Center
- Aurora Sinai Medical Center
- Vince Lombardi Cancer Clinic - Oshkosh
- Aurora Cancer Care-Racine
- Vince Lombardi Cancer Clinic-Sheboygan
- Aurora Medical Center in Summit
- Vince Lombardi Cancer Clinic-Two Rivers
- Aurora Cancer Care-Milwaukee West
- Aurora West Allis Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Breast Cancer Patients
Non-Cancer Controls
Arm Description
Breast cancer patients receiving non-anthracycline or anthracycline chemotherapy Cardiac MRIs will be performed baseline, 3 months (for cancer patients only), and 24 months. Baseline: Collect innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, on 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers. Measurements will be repeated at 3±1, 12±2 and 24±2 months after initiation of chemotherapy treatment.
Non-Cancer Controls Cardiac MRIs will be performed baseline and 24 months. Baseline: Collect innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers. Measurements will be repeated at 3±1, 12±2 (after the completion of radiation) and 24±2 months after initiation of baseline activities.
Outcomes
Primary Outcome Measures
FACT-Fatigue
Participants rate the degree to which each item applies in the past 7 days prior to Baseline using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.
Change in FACT-Fatigue Results
Participants rate the degree to which each item applies in the past 7 days using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.
Change in FACT-Fatigue Results
Participants rate the degree to which each item applies in the past 7 days using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.
Change in FACT-Fatigue Results
Participants rate the degree to which each item applies in the past 7 days using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.
Change in MRI Exam Results
The exam will measure left ventricular volumes, ejection fraction, myocardial strain/strain rate, mass, mapping, aortic pulse wave velocity and aortic wall thickness. The exam will take 10 - 15 minutes to complete.
Change in 6 Minute Walk Results
The purpose of this test is to find out how far the participant can walk in 6 minutes.
Secondary Outcome Measures
Cohen's 4-item Perceived Stress Scale (PSS)
A summed scale asking how often over the prior two weeks four aspects of stress were experienced (1=never to 5=very often)
o weeks four aspects of stress were experienced (1=never to 5=very often)
Cook-Medley Hostility Scale
A 14-item scale used to assess the effect of hostility associated with cardiovascular risk factors.
Minimum Score: 0 Maximum Score: 13 Higher values indicate greater hostility.
Changes in FACT-Fatigue Results
Participants rate the degree to which each item applies in the past 7 days using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.
6 Minute Walk Results
The purpose of this test is to find out how far the participant can walk in 6 minutes.
RAND MOS 36-item Short Form Health Survey (SF-36)
SF-36 consists of 36 items measuring the following 8 domains: physical function, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional health problems, and mental health. These 8 domains also provide two summary scores.
Center for Epidemiological Studies Depression Scale (CESD-10)
Screening questionnaire assessing depressive symptoms during the last week
Godin Leisure-Time Exercise Questionnaire (LTEQ)
Main process measure of physical activity participation
PACE Adult Sedentary Behaviors Survey
Assess sedentary lifestyle behaviors
PROMIS Short Form 8A Measure of Sleep Disturbance
Assess time course and risk factors associated with sleep disturbance and fatigue
Minimum Score: Raw: 8, T-score: 28.9 Maximum Score: Raw: 40, T-score: 76.5 Higher values represent greater sleep disturbance.
PROMIS Applied Cognitive Abilities Short Form 8A and Applied Cognition General Concerns Short Form 8A
Measurement of different aspects of cognitive functioning.
PROMIS Applied Cognitive Abilities Short Form 8A
- Minimum Score: Raw: 8, T-score: 27.0 Maximum Score: Raw: 40, T-score: 64.8 Higher values represent better cognition.
Applied Cognition General Concerns Short Form 8A
- Minimum Score: Raw: 8, T-score: 23.3 Maximum Score: Raw: 40, T-score: 62.7 Higher values represent better cognition.
Walking Efficacy for Duration Scale
Comprised of six items and will be included as a measure of exercise capacity
Chair Stands - Measures Leg Strength
Participants will be first asked to stand from a sitting position without using their arms. If they can perform the task, they will then be asked to stand up and sit down five times as quickly as possible. The time to complete the task will be recorded.
Standing Balance Test
Participants will be asked to maintain balance for up to 30 seconds in three positions characterized by a progressive narrowing of the base support.
Gait Speed Test
Participants will be instructed to start at a marked walking course with toes touching the start line and when cued to start, will begin walking at their ususal speed. The time to walk from the starting line to the end of the 4-meter walk will be recorded.
Grip Strength
Grip strength is assessed with an isometric handgrip dynamometer while the participant is sitting with the head facing straight ahead. The elbow should be bent at a 90 degree angle and the wrist should be at the mid-prone position.
Range of Motion
Range of motion at the shoulder joint will be assessed with shoulder flexion and shoulder abduction with a goniometer.
KCCQ-12 Questionnaire
Independently measures the patient's perception of their health status which includes heart failure symptoms (frequency and burden), physical and social limitations, and how their heart failure impacts their QOL within a 2-week recall period.
Full Information
NCT ID
NCT02791581
First Posted
May 20, 2016
Last Updated
September 25, 2023
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02791581
Brief Title
Understanding and Predicting Breast Cancer Events After Treatment
Acronym
UPBEAT
Official Title
Understanding and Predicting Breast Cancer Events After Treatment (UPBEAT)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 21, 2017 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
July 31, 2034 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is being done to see if patients receiving chemotherapy for breast cancer affects the heart, the ability to exercise and fatigue when compared to patients who do not have cancer.
Detailed Description
840 women aged ≥18 years old scheduled to receive chemotherapy for Stage I-III breast cancer and a comparison population of 160 women without cancer (1,000 total). Equal numbers of women will be recruited aged < 52 vs. > 52. At baseline, innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, on 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers will be collected.
Measurements will be repeated at 3±1, 12±2 and 24±2 months. This study will assess the relevance of pre-existing factors such as age, black/white race, hypertension, smoking (yes/no), diabetes, coronary artery disease, menopause status, CV medications, and physical activity on the study outcomes. Also, this study will assess dynamic change in modifiable CV risk factors (including BMI, blood pressure, serum lipids, serum glucose, physical activity, psychosocial factors, lifestyle behaviors), and the cancer treatment including chemotherapy, radiation therapy, immunotherapy, and surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer, Fatigue, Cardiovascular Events
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
403 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Breast Cancer Patients
Arm Type
Experimental
Arm Description
Breast cancer patients receiving non-anthracycline or anthracycline chemotherapy Cardiac MRIs will be performed baseline, 3 months (for cancer patients only), and 24 months.
Baseline: Collect innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, on 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers.
Measurements will be repeated at 3±1, 12±2 and 24±2 months after initiation of chemotherapy treatment.
Arm Title
Non-Cancer Controls
Arm Type
Experimental
Arm Description
Non-Cancer Controls Cardiac MRIs will be performed baseline and 24 months. Baseline: Collect innovative MRI measures of CV function (LV and aorta); measurements of submaximal (6-minute walk) and, 45% of the cohort, maximal (peak VO2) exercise capacity; questionnaire data to assess fatigue and behavioral and psychosocial risk factors; and biomarkers.
Measurements will be repeated at 3±1, 12±2 (after the completion of radiation) and 24±2 months after initiation of baseline activities.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiac MRI
Intervention Description
Breast Cancer Patients Cardiac MRIs will be performed baseline, 3 months (for cancer patients only), and 24 months.
Non-Cancer Controls Cardiac MRIs will be performed baseline and 24 months.
Primary Outcome Measure Information:
Title
FACT-Fatigue
Description
Participants rate the degree to which each item applies in the past 7 days prior to Baseline using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.
Time Frame
Baseline
Title
Change in FACT-Fatigue Results
Description
Participants rate the degree to which each item applies in the past 7 days using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.
Time Frame
Baseline and 3 months
Title
Change in FACT-Fatigue Results
Description
Participants rate the degree to which each item applies in the past 7 days using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.
Time Frame
Baseline, 3 months and 12 months
Title
Change in FACT-Fatigue Results
Description
Participants rate the degree to which each item applies in the past 7 days using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.
Time Frame
Baseline, 3 months, 12 months and 24 months
Title
Change in MRI Exam Results
Description
The exam will measure left ventricular volumes, ejection fraction, myocardial strain/strain rate, mass, mapping, aortic pulse wave velocity and aortic wall thickness. The exam will take 10 - 15 minutes to complete.
Time Frame
Baseline, 3 months and 24 months
Title
Change in 6 Minute Walk Results
Description
The purpose of this test is to find out how far the participant can walk in 6 minutes.
Time Frame
Baseline, 3 months, 12 months and 24 months
Secondary Outcome Measure Information:
Title
Cohen's 4-item Perceived Stress Scale (PSS)
Description
A summed scale asking how often over the prior two weeks four aspects of stress were experienced (1=never to 5=very often)
o weeks four aspects of stress were experienced (1=never to 5=very often)
Time Frame
Baseline, 3 months, 12 months, and 24 months
Title
Cook-Medley Hostility Scale
Description
A 14-item scale used to assess the effect of hostility associated with cardiovascular risk factors.
Minimum Score: 0 Maximum Score: 13 Higher values indicate greater hostility.
Time Frame
Baseline
Title
Changes in FACT-Fatigue Results
Description
Participants rate the degree to which each item applies in the past 7 days using a 5-point scale. Scores range from 0-52, with higher scores indicating greater fatigue.
Time Frame
Baseline, 3 months, 12 months, and 24 months
Title
6 Minute Walk Results
Description
The purpose of this test is to find out how far the participant can walk in 6 minutes.
Time Frame
Baseline, 3 months, 12 months and 24 months
Title
RAND MOS 36-item Short Form Health Survey (SF-36)
Description
SF-36 consists of 36 items measuring the following 8 domains: physical function, role limitations due to physical health problems, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional health problems, and mental health. These 8 domains also provide two summary scores.
Time Frame
Baseline, 3 months, 12 months and 24 months
Title
Center for Epidemiological Studies Depression Scale (CESD-10)
Description
Screening questionnaire assessing depressive symptoms during the last week
Time Frame
Baseline, 3 months, 12 months and 24 months
Title
Godin Leisure-Time Exercise Questionnaire (LTEQ)
Description
Main process measure of physical activity participation
Time Frame
Baseline, 3 months, 12 months and 24 months
Title
PACE Adult Sedentary Behaviors Survey
Description
Assess sedentary lifestyle behaviors
Time Frame
Baseline, 3 months, 12 months and 24 months
Title
PROMIS Short Form 8A Measure of Sleep Disturbance
Description
Assess time course and risk factors associated with sleep disturbance and fatigue
Minimum Score: Raw: 8, T-score: 28.9 Maximum Score: Raw: 40, T-score: 76.5 Higher values represent greater sleep disturbance.
Time Frame
Baseline, 3 months, 12 months and 24 months
Title
PROMIS Applied Cognitive Abilities Short Form 8A and Applied Cognition General Concerns Short Form 8A
Description
Measurement of different aspects of cognitive functioning.
PROMIS Applied Cognitive Abilities Short Form 8A
- Minimum Score: Raw: 8, T-score: 27.0 Maximum Score: Raw: 40, T-score: 64.8 Higher values represent better cognition.
Applied Cognition General Concerns Short Form 8A
- Minimum Score: Raw: 8, T-score: 23.3 Maximum Score: Raw: 40, T-score: 62.7 Higher values represent better cognition.
Time Frame
Baseline, 3 months, 12 months and 24 months
Title
Walking Efficacy for Duration Scale
Description
Comprised of six items and will be included as a measure of exercise capacity
Time Frame
Baseline, 3 months, 12 months and 24 months
Title
Chair Stands - Measures Leg Strength
Description
Participants will be first asked to stand from a sitting position without using their arms. If they can perform the task, they will then be asked to stand up and sit down five times as quickly as possible. The time to complete the task will be recorded.
Time Frame
Baseline, 3 months, 12 months and 24 months
Title
Standing Balance Test
Description
Participants will be asked to maintain balance for up to 30 seconds in three positions characterized by a progressive narrowing of the base support.
Time Frame
Baseline, 3 months, 12 months and 24 months
Title
Gait Speed Test
Description
Participants will be instructed to start at a marked walking course with toes touching the start line and when cued to start, will begin walking at their ususal speed. The time to walk from the starting line to the end of the 4-meter walk will be recorded.
Time Frame
Baseline, 3 months, 12 months and 24 months
Title
Grip Strength
Description
Grip strength is assessed with an isometric handgrip dynamometer while the participant is sitting with the head facing straight ahead. The elbow should be bent at a 90 degree angle and the wrist should be at the mid-prone position.
Time Frame
Baseline, 3 months, 12 months and 24 months
Title
Range of Motion
Description
Range of motion at the shoulder joint will be assessed with shoulder flexion and shoulder abduction with a goniometer.
Time Frame
Baseline, 3 months, 12 months and 24 months
Title
KCCQ-12 Questionnaire
Description
Independently measures the patient's perception of their health status which includes heart failure symptoms (frequency and burden), physical and social limitations, and how their heart failure impacts their QOL within a 2-week recall period.
Time Frame
Baseline, 24 months
Other Pre-specified Outcome Measures:
Title
B-type natriuretic peptide (BNP)
Description
Serum BNP as a predictor of exercise intolerance
Time Frame
Baseline and 24 months
Title
Troponin - 1
Description
Acquired to determine associations between troponin levels during therapy and the onset of cardiac and vascular dysfunction, exercise capacity, and fatigue.
Time Frame
Baseline and 3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for Women with Stage I - III Breast Cancer:
Stage I-III female breast cancer (including inflammatory and newly diagnosed or locally recurrent breast cancer) but not metastatic breast cancer being treated with curative intent
> 18 years old
Scheduled to receive chemotherapy and/or estrogen antagonist aromatase inhibitors (anastrozole [Arimidex], letrozole [Femara], exemestane [Aromasin]).
Able to hold breath for 10 seconds
ECOG performance status 0 -2
Able to walk at least 2 blocks without chest pain, dyspnea, shortness of breath or fainting
Able to exercise on a treadmill or stationary cycle
Participants in other ongoing clinical trials are eligible for this study
Exclusion Criteria for Women with Stage I-III Breast Cancer:
Those with ferromagnetic cerebral aneurysm clips or other intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices (patients with tissue expanders will not be excluded)
If previously measured, known LVEF <50%
Symptomatic claustrophobia
Unable to provide informed consent
At the beginning of the study, pregnant women and women who are breast-feeding will not be enrolled.
Severe pulmonary hypertension
Within the past 6 months:
Acute pulmonary embolus
Deep vein thrombosis
Within the past month:
Heart attack
Unstable or stable angina (cardiac chest pain)
Left main coronary artery disease
Symptomatic heart failure
Uncontrolled hypertension (SBP > 180 mm Hg or DBP > 120 mm Hg)
Severe valvular heart disease
Uncontrolled metabolic disease (diabetes with fasting BS >300 mg/dl, thyrotoxicosis, myxedema)
Aortic aneurism (>45 mm diameter) or aortic dissection
Uncontrolled slow or fast heart rhythm causing symptoms or hemodynamic compromise
Hypertrophic obstructive cardiomyopathy
Patient does not understand English
Inclusion Criteria for Women Free of Cancer for Comparison:
Healthy female without known coronary artery disease > 18 years old
Able to hold breath 10 seconds
ECOG performance status = 0 or 1
Able to walk at least 2 blocks without chest pain, dyspnea, shortness of breath or fainting
Able to exercise on a treadmill or stationary cycle
No personal history of cancer other than superficial skin cancers
Has never received chemotherapy, radiation therapy, immunotherapy, or had breast cancer related surgery
If previously measured, LVEF ≥ 50%
Exclusion Criteria for Women Free of Cancer for Comparison:
Inflammatory conditions such as lupus or inflammatory bowel disease
Overt coronary artery disease or heart failure
Those with ferromagnetic cerebral aneurysm clips or other intracranial metal; pacemakers, defibrillators, functioning neurostimulator devices or other implanted non-compatible MRI devices
Symptomatic claustrophobia
Unable to provide informed consent
At the beginning of the study, pregnant women or women who are breast feeding will not be enrolled.
Severe pulmonary hypertension
Within the past 6 months:
Acute pulmonary embolus
Deep vein thrombosis
Within the past month:
Heart attack
Unstable or stable angina (cardiac chest pain)
Left main coronary artery disease
Symptomatic heart failure
Uncontrolled hypertension (SBP > 180 mm Hg or DBP > 120 mm Hg)
Severe valvular heart disease
Uncontrolled metabolic disease (diabetes with fasting BS >300 mg/dl, thyrotoxicosis, myxedema)
Aortic aneurism (>45 mm diameter) or aortic dissection
Uncontrolled slow or fast heart rhythm causing symptoms or hemodynamic compromise
Hypertrophic obstructive cardiomyopathy
Patient does not understand English
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Hundley, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
MedStar Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Moffitt Cancer Center - McKinley Campus
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
IU Health North Hospital
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46032
Country
United States
Facility Name
Indiana University/Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Springmill Medical Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
University of Kansas Hospital-Westwood Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Beaumont Hospital - Dearborn
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Beaumont Hospital - Farmington Hills
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Facility Name
Spectrum Health at Butterworth Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
William Beaumont Hospital-Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
William Beaumont Hospital - Troy
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Facility Name
Saint John's Hospital - Healtheast
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Abbott-Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Health Partners Inc
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Minnesota Oncology Hematology PA-Woodbury
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Newton Medical Center
City
Newton
State/Province
New Jersey
ZIP/Postal Code
07860
Country
United States
Facility Name
Overlook Hospital
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07902
Country
United States
Facility Name
Randolph Hospital
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203
Country
United States
Facility Name
Cone Health Cancer Center at Alamance Regional
City
Burlington
State/Province
North Carolina
ZIP/Postal Code
27215
Country
United States
Facility Name
Novant Health Presbyterian Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Cone Health Cancer Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
UPMC Pinnacle Cancer Center/Community Osteopathic Campus
City
Harrisburg
State/Province
Pennsylvania
ZIP/Postal Code
17109
Country
United States
Facility Name
University of Pennsylvania/Abramson Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
UPMC Memorial
City
York
State/Province
Pennsylvania
ZIP/Postal Code
17408
Country
United States
Facility Name
Prisma Health Cancer Institute - Spartanburg
City
Boiling Springs
State/Province
South Carolina
ZIP/Postal Code
29316
Country
United States
Facility Name
Prisma Health Cancer Institute - Easley
City
Easley
State/Province
South Carolina
ZIP/Postal Code
29640
Country
United States
Facility Name
Prisma Health Cancer Institute - Butternut
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Prisma Health Cancer Institute - Faris
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Prisma Health Greenville Memorial Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Prisma Health Cancer Institute - Eastside
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Prisma Health Cancer Institute - Greer
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Prisma Health Cancer Institute - Seneca
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29672
Country
United States
Facility Name
UT Southwestern/Simmons Cancer Center-Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Centra Lynchburg Hematology-Oncology Clinic Inc
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Virginia Cancer Institute
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
VCU Massey Cancer Center at Stony Point
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23235
Country
United States
Facility Name
Virginia Commonwealth University/Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Shenandoah Oncology PC
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
University of Washington Medical Center - Montlake
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Aurora Cancer Care-Southern Lakes VLCC
City
Burlington
State/Province
Wisconsin
ZIP/Postal Code
53105
Country
United States
Facility Name
Aurora Health Center-Fond du Lac
City
Fond Du Lac
State/Province
Wisconsin
ZIP/Postal Code
54937
Country
United States
Facility Name
Aurora Health Care Germantown Health Center
City
Germantown
State/Province
Wisconsin
ZIP/Postal Code
53022
Country
United States
Facility Name
Aurora Cancer Care-Grafton
City
Grafton
State/Province
Wisconsin
ZIP/Postal Code
53024
Country
United States
Facility Name
Aurora BayCare Medical Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54311
Country
United States
Facility Name
Aurora Cancer Care-Kenosha South
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States
Facility Name
Aurora Cancer Care-Milwaukee
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Aurora Saint Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Aurora Sinai Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
Facility Name
Vince Lombardi Cancer Clinic - Oshkosh
City
Oshkosh
State/Province
Wisconsin
ZIP/Postal Code
54904
Country
United States
Facility Name
Aurora Cancer Care-Racine
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53406
Country
United States
Facility Name
Vince Lombardi Cancer Clinic-Sheboygan
City
Sheboygan
State/Province
Wisconsin
ZIP/Postal Code
53081
Country
United States
Facility Name
Aurora Medical Center in Summit
City
Summit
State/Province
Wisconsin
ZIP/Postal Code
53066
Country
United States
Facility Name
Vince Lombardi Cancer Clinic-Two Rivers
City
Two Rivers
State/Province
Wisconsin
ZIP/Postal Code
54241
Country
United States
Facility Name
Aurora Cancer Care-Milwaukee West
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Aurora West Allis Medical Center
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.
IPD Sharing Time Frame
6 months after publication for a 2 year duration
IPD Sharing Access Criteria
upon request to NCORP@wakehealth.edu
Citations:
PubMed Identifier
35775211
Citation
Bellissimo MP, Canada JM, Jordan JH, Ladd AC, Heiston EM, Brubaker P, Mihalko SL, Reding K, D Agostino R, O Connell N, Hackney MH, Weaver KE, Lesser GJ, Avis NE, Hundley WG. Changes in Physical Activity, Functional Capacity, and Cardiac Function during Breast Cancer Therapy. Cancer Epidemiol Biomarkers Prev. 2022 Jul 1;31(7):1509. doi: 10.1158/1055-9965.EPI-22-0470.
Results Reference
derived
Learn more about this trial
Understanding and Predicting Breast Cancer Events After Treatment
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