MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum
NCT ID: NCT01719562
Last Updated: 2023-05-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
28 participants
INTERVENTIONAL
2013-01-01
2022-03-08
Brief Summary
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Exercise Capacity Addendum Brief Summary: This study is designed to demonstrate feasibility of performing the physical activity intervention and the primary outcome measures before, during and six months after initiating Anth-bC for treatment of non- or Hodgkin lymphoma. This study will test the potential for a novel (lifestyle) intervention designed to improve exercise capacity, health-related quality of life and cardiac and cognitive dysfunction. This data will inform the development of the R33 phase of the clinical trial to determine if the physical activity intervention can reduce exercise intolerance in this high-risk population. In addition, cardiac MRI data from individuals within this pilot will be compared to cardiac MRI data from individuals in the parent study that did not undergo either of the two interventional arms of this study.
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Detailed Description
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I. To design an automated MRI hardware/software platform for measuring and reporting left ventricular (LV) function (volumes, strain, and ejection fraction \[EF\]), T1 myocardial signal, and aortic pulse wave velocity (PWV).
II. To determine if pre- to 3 month post-anthracycline-based chemotherapy (Anth-bC) changes in our MRI platform generated measures of LV volumes, EF, strain, myocardial T1, and aortic PWV predict pre- to 24 month post-Anth-bC differences in these same parameters.
OUTLINE:
Patients undergo MRI scans for LV function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Exercise Capacity Addendum Objectives:
Primary Objective:
* To provide critical participant enrollment data necessary to accomplish the R01 submission, including:
* Feasibility of screening, enrolling, and randomizing 21 Non or Hodgkin lymphoma and stage I-IV breast cancer patients including the reasons for failed randomization,
* Identification of barriers for participating in, or adhering to the Patient ES-AI and the Healthy Living Control Group.
Secondary Objective:
• In these 21 patients, at study initiation then 3 and 6 months after initiating Anth-bC or other potentially cardiotoxic cancer therapies, to assess the ability to ascertain: peak exercise cardiac output, calculated arteriovenous oxygen difference (A-V O2) and VO2 (maximum rate of oxygen), and pre-exercise measures of left ventricular and cognitive function, health-related quality of life, six-minute walk distance (6min WD) and fatigue. Ascertainment of the left ventricular function and health-related rate quality of life will be attempted in a manner similar to ascertainment of these variables from 47 individuals with lymphoma in the parent study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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ADDENDUM: Physical Activity Intervention
Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.
Magnetic resonance imaging
Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Physical Activity
Tailored aerobic exercise program onsite and at home.
Cardiopulmonary Exercise Testing (CPET)
Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration
A self-administered 13-item scale to assess fatigue in participants
ADDENDUM: Healthy Living Instruction Group (Control Arm)
Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .
Magnetic resonance imaging
Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Healthy Living
Healthy living presentations at a centralized meeting place and over the phone.
Cardiopulmonary Exercise Testing (CPET)
Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration
A self-administered 13-item scale to assess fatigue in participants
MRI (Diagnostic)
Patients undergo MRI scans for LV function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Magnetic resonance imaging
Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Physical Activity
Tailored aerobic exercise program onsite and at home.
Healthy Living
Healthy living presentations at a centralized meeting place and over the phone.
Interventions
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Magnetic resonance imaging
Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Physical Activity
Tailored aerobic exercise program onsite and at home.
Healthy Living
Healthy living presentations at a centralized meeting place and over the phone.
Cardiopulmonary Exercise Testing (CPET)
Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
Questionnaire Administration
A self-administered 13-item scale to assess fatigue in participants
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Ability to understand and the willingness to sign a written informed consent document
* Men and women aged 18-85 with non- or Hodgkin lymphoma or I-IV stage breast cancer patients that expect to receive an anthracycline based chemotherapeutic regimen or other potentially cardiotoxic cancer therapies (e.g. chemotherapy regimens \[anthracyclines, trastuzumab\]), immuno-therapies (immune checkpoint inhibitors \[ICI's\]) or radiation (within 8 weeks of completion).
* Potential enrollees will need the capacity to walk at least two (2) city blocks on a flat surface.
* English speaking participants only will be enrolled.
* Stage IV breast cancer participants must have a 2 year survival prognosis and approval from their physician.
Exclusion Criteria
* Ferromagnetic cerebral aneurysm clips, or other intraorbital/intracranial metal
* Allergy to gadolinium or other severe drug allergies
* Unstable angina
* Significant ventricular arrhythmias (\> 20 premature ventricular contractions \[PVCs\]/minute due to gating difficulty)
* Acute myocardial infarction within 28 days
* Atrial fibrillation with uncontrolled ventricular response
* Moderate or severe aortic stenosis
* Claustrophobia
* Congestive heart failure (New York Heart Association \[NYHA\] class III or IV)
* Significant valvular disease, or significant pulmonary disease requiring supplemental oxygen therapy
* Participants unwilling to complete the protocol (24 month duration)
* Women who are pregnant
* Patients unable or unwilling to provide informed consent
EXERCISE CAPACITY ADDENDUM:
* Uncontrolled hypertension (systolic blood pressure \>190 mm Hg or diastolic blood pressure \>100 mm Hg)
* A recent history of alcohol or drug abuse.
* Inflammatory conditions such as lupus or inflammatory bowel disease, or another medical condition that might compromise safety or successful completion.
* Other exclusions include those with contraindications to MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices.
* Unstable angina.
* Inability to exercise on a treadmill or stationary cycle.
* Significant ventricular arrhythmias (\>20 PVCs/min due to gating difficulty).
* Atrial fibrillation with uncontrolled ventricular response.
* Acute myocardial infarction within 28 days.
* Moving within 12 months of enrollment.
18 Years
85 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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William Hundley
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Virginia Commonwealth University Health Sciences
Richmond, Virginia, United States
Countries
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References
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Costa JV, Lucas AR, Mihalko SL, Brubaker PH, Marshall A, Leitzelar B, Wolle BR, Norton S, Franco RL, Via J, Yazbeck V, Vaidya R, Seegars MB, D'Agostino R Jr, Wagner L, Hundley WG. Feasibility and preliminary efficacy of a physical activity intervention in adults with lymphoma undergoing treatment. Pilot Feasibility Stud. 2025 Jan 14;11(1):6. doi: 10.1186/s40814-024-01580-7.
Mabudian L, Reding K, D'Agostino RB Jr, Heiston EM, Bellissimo MP, Olson K, Ntim WO, Klepin HD, Dressler EV, Moore T, Jordan JH, O'Connell NS, Ladd A, Weaver KE, Ky B, Wagner LI, Hackney MH, Lesser GJ, Hundley WG; UPBEAT Study Team. The relationship between body composition and left ventricular performance in women with breast, lymphoma, or sarcoma cancer. Cardiooncology. 2024 Jun 6;10(1):34. doi: 10.1186/s40959-024-00233-1.
Garg R, D'Agostino RB Jr, O'Connell N, Lesser GJ, Salloum FN, Hines AL, Melendez GC, Jordan JH, Ky B, Wagner LI, Sutton AL, Bottinor W, Olson KC, Ladd AC, Hundley WG; UPBEAT Study Team. Hypertension Severity and Declines in Left Ventricular Ejection Fraction Among Women Receiving Adjuvant Chemotherapy for Breast Cancer (WF-97415 UPBEAT). Hypertension. 2024 Jun;81(6):1365-1373. doi: 10.1161/HYPERTENSIONAHA.123.21817. Epub 2024 Apr 18.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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NCI-2012-01613
Identifier Type: REGISTRY
Identifier Source: secondary_id
CCCWFU 99112
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00020968
Identifier Type: -
Identifier Source: org_study_id
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