Clinical trial NCT01719562: MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum
Official title: 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"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Toxicity
Malignant Neoplasm
Breast Cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-11-01
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: For the exercise capacity portion of this trial, participants will be randomized to 1 of 2 arms.
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: PARENT STUDY:

Inclusion Criteria:

* Receiving \>= 350 mg/m\^2 of Anth-bC therapy, or a combination of Anth-bC (\>= 250 mg/m\^2) and subsequent paclitaxel or Herceptin
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices, or other implanted electronic devices
* 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:

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.

Primary outcomes:
measure: Number of Participants Completing the Trial (Exercise Capacity Addendum)
timeFrame: 6 months after treatment initiation
measure: Number of Participants Able to Complete Assessments (Exercise Capacity Addendum)
timeFrame: 6 months after treatment initiation
Secondary outcomes:
measure: Peak Exercise Cardiac Output (Exercise Capacity Addendum)
timeFrame: 6 months after treatment
measure: Arteriovenous Oxygen Difference (A-V O2) (Exercise Capacity Addendum)
timeFrame: 6 months after treatment initiation
measure: Maximum Rate of Oxygen Consumption (VO2) (Exercise Capacity Addendum)
timeFrame: 6 months after treatment initiation
measure: Left Ventricular Function (Exercise Capacity Addendum)
timeFrame: 6 months after treatment initiation
measure: Cognitive Function- Controlled Oral Word Association (COWA) Test (Exercise Capacity Addendum)
timeFrame: 6 months after treatment initiation
measure: Health-Related Quality of Life (Exercise Capacity Addendum)
timeFrame: 6 months after treatment initiation
measure: 6-minute Walk Distance (Exercise Capacity Addendum)
timeFrame: 6 months after treatment initiation
measure: Functional Assessment of Cancer Therapy - (FACT-Fatigue) (Exercise Capacity Addendum)
timeFrame: 6 months after treatment initiation
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
city: Richmond
country: United States
facility: Virginia Commonwealth University Health Sciences
state: Virginia
Study officials:
affiliation: Wake Forest University Health Sciences
name: William Hundley
role: PRINCIPAL_INVESTIGATOR
References: