Description:
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.
Title
- Brief Title: Understanding and Predicting Breast Cancer Events After Treatment
- Official Title: Understanding and Predicting Breast Cancer Events After Treatment (UPBEAT)
Clinical Trial IDs
- ORG STUDY ID:
IRB00045463
- SECONDARY ID:
WF 97415
- SECONDARY ID:
1R01CA199167-01
- SECONDARY ID:
NCI-2017-00386
- SECONDARY ID:
NCI-2017-00386
- NCT ID:
NCT02791581
Conditions
Purpose
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.
Trial Arms
| Name | Type | Description | Interventions |
|---|
| Breast Cancer Patients | Experimental | 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 | Experimental | 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. | |
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
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | Female |
| Healthy Volunteers: | Accepts Healthy Volunteers |
Primary Outcome Measures
| Measure: | FACT-Fatigue |
| Time Frame: | Baseline |
| Safety Issue: | |
| 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. |
Secondary Outcome Measures
| Measure: | Cohen's 4-item Perceived Stress Scale (PSS) |
| Time Frame: | Baseline, 3 months, 12 months, and 24 months |
| Safety Issue: | |
| 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) |
| Measure: | Cook-Medley Hostility Scale |
| Time Frame: | Baseline |
| Safety Issue: | |
| 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. |
| Measure: | Changes in FACT-Fatigue Results |
| Time Frame: | Baseline, 3 months, 12 months, and 24 months |
| Safety Issue: | |
| 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. |
| Measure: | 6 Minute Walk Results |
| Time Frame: | Baseline, 3 months, 12 months and 24 months |
| Safety Issue: | |
| Description: | The purpose of this test is to find out how far the participant can walk in 6 minutes. |
| Measure: | RAND MOS 36-item Short Form Health Survey (SF-36) |
| Time Frame: | Baseline, 3 months, 12 months and 24 months |
| Safety Issue: | |
| 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. |
| Measure: | Center for Epidemiological Studies Depression Scale (CESD-10) |
| Time Frame: | Baseline, 3 months, 12 months and 24 months |
| Safety Issue: | |
| Description: | Screening questionnaire assessing depressive symptoms during the last week |
| Measure: | Godin Leisure-Time Exercise Questionnaire (LTEQ) |
| Time Frame: | Baseline, 3 months, 12 months and 24 months |
| Safety Issue: | |
| Description: | Main process measure of physical activity participation |
| Measure: | PACE Adult Sedentary Behaviors Survey |
| Time Frame: | Baseline, 3 months, 12 months and 24 months |
| Safety Issue: | |
| Description: | Assess sedentary lifestyle behaviors |
| Measure: | PROMIS Short Form 8A Measure of Sleep Disturbance |
| Time Frame: | Baseline, 3 months, 12 months and 24 months |
| Safety Issue: | |
| 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. |
| Measure: | PROMIS Applied Cognitive Abilities Short Form 8A and Applied Cognition General Concerns Short Form 8A |
| Time Frame: | Baseline, 3 months, 12 months and 24 months |
| Safety Issue: | |
| 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. |
| Measure: | Walking Efficacy for Duration Scale |
| Time Frame: | Baseline, 3 months, 12 months and 24 months |
| Safety Issue: | |
| Description: | Comprised of six items and will be included as a measure of exercise capacity |
| Measure: | Chair Stands - Measures Leg Strength |
| Time Frame: | Baseline, 3 months, 12 months and 24 months |
| Safety Issue: | |
| 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. |
| Measure: | Standing Balance Test |
| Time Frame: | Baseline, 3 months, 12 months and 24 months |
| Safety Issue: | |
| 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. |
| Measure: | Gait Speed Test |
| Time Frame: | Baseline, 3 months, 12 months and 24 months |
| Safety Issue: | |
| 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. |
| Measure: | Grip Strength |
| Time Frame: | Baseline, 3 months, 12 months and 24 months |
| Safety Issue: | |
| 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. |
| Measure: | Range of Motion |
| Time Frame: | Baseline, 3 months, 12 months and 24 months |
| Safety Issue: | |
| Description: | Range of motion at the shoulder joint will be assessed with shoulder flexion and shoulder abduction with a goniometer. |
| Measure: | KCCQ-12 Questionnaire |
| Time Frame: | Baseline, 24 months |
| Safety Issue: | |
| 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. |
Details
| Phase: | N/A |
| Primary Purpose: | Interventional |
| Overall Status: | Active, not recruiting |
| Lead Sponsor: | Wake Forest University Health Sciences |
Trial Keywords
- Breast Cancer
- Fatigue
- Cardiovascular Events
Last Updated
August 19, 2021
