MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum
Condition: Cardiac Toxicity; Malignant Neoplasm; Breast Cancer
MeSH terms: Breast Neoplasms; Neoplasms; Cardiotoxicity
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Magnetic resonance imaging; Physical Activity; Healthy Living; Cardiopulmonary Exercise Testing (CPET); Questionnaire Administration
Intervention type(s): Procedure; Other; Other; Device; Other
Intervention description(s): Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.; Tailored aerobic exercise program onsite and at home.; Healthy living presentations at a centralized meeting place and over the phone.; Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.; A self-administered 13-item scale to assess fatigue in participants
Other intervention name(s): MRI; NMR imaging; NMRI; nuclear magnetic resonance imaging
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: For the exercise capacity portion of this trial, participants will be randomized to 1 of 2 arms.
Masking: None (Open Label)
Primary purpose: Diagnostic