Clinical trial NCT02791581: Understanding and Predicting Breast Cancer Events After Treatment
Official title: Understanding and Predicting Breast Cancer Events After Treatment (UPBEAT)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Breast Cancer
Fatigue
Cardiovascular Events
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-06-07
Enrollment: 403
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: FACT-Fatigue
timeFrame: Baseline
measure: Change in FACT-Fatigue Results
timeFrame: Baseline and 3 months
measure: Change in FACT-Fatigue Results
timeFrame: Baseline, 3 months and 12 months
measure: Change in FACT-Fatigue Results
timeFrame: Baseline, 3 months, 12 months and 24 months
measure: Change in MRI Exam Results
timeFrame: Baseline, 3 months and 24 months
measure: Change in 6 Minute Walk Results
timeFrame: Baseline, 3 months, 12 months and 24 months
Secondary outcomes:
measure: Cohen's 4-item Perceived Stress Scale (PSS)
timeFrame: Baseline, 3 months, 12 months, and 24 months
measure: Cook-Medley Hostility Scale
timeFrame: Baseline
measure: Changes in FACT-Fatigue Results
timeFrame: Baseline, 3 months, 12 months, and 24 months
measure: 6 Minute Walk Results
timeFrame: Baseline, 3 months, 12 months and 24 months
measure: RAND MOS 36-item Short Form Health Survey (SF-36)
timeFrame: Baseline, 3 months, 12 months and 24 months
measure: Center for Epidemiological Studies Depression Scale (CESD-10)
timeFrame: Baseline, 3 months, 12 months and 24 months
measure: Godin Leisure-Time Exercise Questionnaire (LTEQ)
timeFrame: Baseline, 3 months, 12 months and 24 months
measure: PACE Adult Sedentary Behaviors Survey
timeFrame: Baseline, 3 months, 12 months and 24 months
measure: PROMIS Short Form 8A Measure of Sleep Disturbance
timeFrame: Baseline, 3 months, 12 months and 24 months
measure: PROMIS Applied Cognitive Abilities Short Form 8A and Applied Cognition General Concerns Short Form 8A
timeFrame: Baseline, 3 months, 12 months and 24 months
measure: Walking Efficacy for Duration Scale
timeFrame: Baseline, 3 months, 12 months and 24 months
measure: Chair Stands - Measures Leg Strength
timeFrame: Baseline, 3 months, 12 months and 24 months
measure: Standing Balance Test
timeFrame: Baseline, 3 months, 12 months and 24 months
measure: Gait Speed Test
timeFrame: Baseline, 3 months, 12 months and 24 months
measure: Grip Strength
timeFrame: Baseline, 3 months, 12 months and 24 months
measure: Range of Motion
timeFrame: Baseline, 3 months, 12 months and 24 months
measure: KCCQ-12 Questionnaire
timeFrame: Baseline, 24 months
Other outcomes:
measure: B-type natriuretic peptide (BNP)
timeFrame: Baseline and 24 months
measure: Troponin - 1
timeFrame: Baseline and 3 months
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham Cancer Center
state: Alabama
city: Washington
country: United States
facility: MedStar Washington Hospital Center
state: District of Columbia
city: Tampa
country: United States
facility: Moffitt Cancer Center - McKinley Campus
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Carmel
country: United States
facility: IU Health North Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University/Melvin and Bren Simon Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Springmill Medical Center
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: Westwood
country: United States
facility: University of Kansas Hospital-Westwood Cancer Center
state: Kansas
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Comprehensive Cancer Center
state: Michigan
city: Dearborn
country: United States
facility: Beaumont Hospital - Dearborn
state: Michigan
city: Farmington Hills
country: United States
facility: Beaumont Hospital - Farmington Hills
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health at Butterworth Campus
state: Michigan
city: Royal Oak
country: United States
facility: William Beaumont Hospital-Royal Oak
state: Michigan
city: Troy
country: United States
facility: William Beaumont Hospital - Troy
state: Michigan
city: Maplewood
country: United States
facility: Saint John's Hospital - Healtheast
state: Minnesota
city: Minneapolis
country: United States
facility: Abbott-Northwestern Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Health Partners Inc
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: United Hospital
state: Minnesota
city: Woodbury
country: United States
facility: Minnesota Oncology Hematology PA-Woodbury
state: Minnesota
city: Morristown
country: United States
facility: Morristown Medical Center
state: New Jersey
city: Newton
country: United States
facility: Newton Medical Center
state: New Jersey
city: Summit
country: United States
facility: Overlook Hospital
state: New Jersey
city: Asheboro
country: United States
facility: Randolph Hospital
state: North Carolina
city: Burlington
country: United States
facility: Cone Health Cancer Center at Alamance Regional
state: North Carolina
city: Charlotte
country: United States
facility: Novant Health Presbyterian Medical Center
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: Cone Health Cancer Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Harrisburg
country: United States
facility: UPMC Pinnacle Cancer Center/Community Osteopathic Campus
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania/Abramson Cancer Center
state: Pennsylvania
city: York
country: United States
facility: UPMC Memorial
state: Pennsylvania
city: Boiling Springs
country: United States
facility: Prisma Health Cancer Institute - Spartanburg
state: South Carolina
city: Easley
country: United States
facility: Prisma Health Cancer Institute - Easley
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Cancer Institute - Butternut
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Cancer Institute - Faris
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Greenville Memorial Hospital
state: South Carolina
city: Greenville
country: United States
facility: Prisma Health Cancer Institute - Eastside
state: South Carolina
city: Greer
country: United States
facility: Prisma Health Cancer Institute - Greer
state: South Carolina
city: Seneca
country: United States
facility: Prisma Health Cancer Institute - Seneca
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern/Simmons Cancer Center-Dallas
state: Texas
city: Lynchburg
country: United States
facility: Centra Lynchburg Hematology-Oncology Clinic Inc
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Richmond
country: United States
facility: VCU Massey Cancer Center at Stony Point
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
city: Winchester
country: United States
facility: Shenandoah Oncology PC
state: Virginia
city: Seattle
country: United States
facility: University of Washington Medical Center - Montlake
state: Washington
city: Burlington
country: United States
facility: Aurora Cancer Care-Southern Lakes VLCC
state: Wisconsin
city: Fond Du Lac
country: United States
facility: Aurora Health Center-Fond du Lac
state: Wisconsin
city: Germantown
country: United States
facility: Aurora Health Care Germantown Health Center
state: Wisconsin
city: Grafton
country: United States
facility: Aurora Cancer Care-Grafton
state: Wisconsin
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
city: Kenosha
country: United States
facility: Aurora Cancer Care-Kenosha South
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Cancer Care-Milwaukee
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Saint Luke's Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Sinai Medical Center
state: Wisconsin
city: Oshkosh
country: United States
facility: Vince Lombardi Cancer Clinic - Oshkosh
state: Wisconsin
city: Racine
country: United States
facility: Aurora Cancer Care-Racine
state: Wisconsin
city: Sheboygan
country: United States
facility: Vince Lombardi Cancer Clinic-Sheboygan
state: Wisconsin
city: Summit
country: United States
facility: Aurora Medical Center in Summit
state: Wisconsin
city: Two Rivers
country: United States
facility: Vince Lombardi Cancer Clinic-Two Rivers
state: Wisconsin
city: Wauwatosa
country: United States
facility: Aurora Cancer Care-Milwaukee West
state: Wisconsin
city: West Allis
country: United States
facility: Aurora West Allis Medical Center
state: Wisconsin
Study officials:
affiliation: Wake Forest University Health Sciences
name: Gregory Hundley, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.