MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum

  • STATUS
    Recruiting
  • days left to enroll
    9
  • participants needed
    130
  • sponsor
    Wake Forest University Health Sciences
Updated on 10 September 2021
paclitaxel
cancer
lymphoma
hodgkin's disease
breast cancer
treatment regimen
MRI
anthracyclines
trastuzumab
primary cancer
stage iv breast cancer
herceptin
cardiac mri
breast cancer staging

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.

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.

Details
Condition Cancer, Breast Cancer, Diet and Nutrition, Chronic Diarrhea, Skin Wounds, Chronic Shoulder Pain, Vaginal Atrophy, Adverse Effects, Drugs, Injection Port, Breast Cancer - HER2 Positive, Anal Dysplasia, Primary Immunodeficiency, Pediatric Health, Near-Sighted Corrective Surgery, Cancer/Tumors, Cardiotoxicity, Peripheral Arterial Occlusive Disease, Breast Cancer Diagnosis, Ewing's Family Tumors, Brain Function, Cardiac Toxicity, Recurrent Respiratory Papillomatosis, Razor Bumps (Pseudofolliculitis Barbae), Cancer (Pediatric), Metastatic Triple-Negative Breast Cancer, Neoplasms, breast carcinoma, primary cancer, primary malignant neoplasm, malignancy, cancers, malignancies, malignant tumor, malignant tumors, cancer, breast
Treatment questionnaire administration, magnetic resonance imaging, physical activity, Healthy Living, Cardiopulmonary Exercise Testing (CPET)
Clinical Study IdentifierNCT01719562
SponsorWake Forest University Health Sciences
Last Modified on10 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

The following are relative contraindications and can be
considered by the medical director of the study
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
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