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

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.

Conditions

• Cardiac Toxicity
• Malignant Neoplasm
• Breast Cancer

Interventions

PROCEDURE

Magnetic resonance imaging

Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.

OTHER

Physical Activity

Tailored aerobic exercise program onsite and at home.

OTHER

Healthy Living

Healthy living presentations at a centralized meeting place and over the phone.

DEVICE

Cardiopulmonary Exercise Testing (CPET)

Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.

OTHER

Questionnaire Administration

A self-administered 13-item scale to assess fatigue in participants

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• William Hundley · Wake Forest University Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-01-01

Primary Completion

2022-03-08

Completion

2022-03-08

FDA Device

Yes

Countries

• United States

Study Locations