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Improving Exercise Capacity With a Tailored Physical Activity Intervention in Lymphoma and Breast Cancer Patients Undergoing Treatment - An Addendum to NIH R01CA167821 "Early Imaging Detection of Cardiovascular Injury After Cancer"
This trial studies how well magnetic resonance imaging (MRI) works in detecting heart damage in patients with cancer receiving chemotherapy. Diagnostic procedures, such as MRI, may help doctors predict whether patients will have heart damage caused by chemotherapy in patients with cancer receiving chemotherapy. 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.
PRIMARY OBJECTIVES: 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.
Age
18 - 85 years
Sex
ALL
Healthy Volunteers
No
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States
Virginia Commonwealth University Health Sciences
Richmond, Virginia, United States
Start Date
January 1, 2013
Primary Completion Date
March 8, 2022
Completion Date
March 8, 2022
Last Updated
May 19, 2023
28
ACTUAL participants
Magnetic resonance imaging
PROCEDURE
Physical Activity
OTHER
Healthy Living
OTHER
Cardiopulmonary Exercise Testing (CPET)
DEVICE
Questionnaire Administration
OTHER
Lead Sponsor
Wake Forest University Health Sciences
Collaborators
NCT05245812
NCT05372640
Data Source & Attribution
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