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

Primary Purpose

Cardiac Toxicity, Malignant Neoplasm, Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Magnetic resonance imaging

Physical Activity

Healthy Living

Cardiopulmonary Exercise Testing (CPET)

Questionnaire Administration

About this trial

This is an interventional diagnostic trial for Cardiac Toxicity

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Comprehensive Cancer Center of Wake Forest University
Virginia Commonwealth University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

ADDENDUM: Physical Activity Intervention

ADDENDUM: Healthy Living Instruction Group (Control Arm)

MRI (Diagnostic)

Arm Description

Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.

Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .

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

Outcomes

Primary Outcome Measures

Number of Participants Completing the Trial (Exercise Capacity Addendum)

The number of participants who completed the intervention.

Number of Participants Able to Complete Assessments (Exercise Capacity Addendum)

Number of participants who completed the 6-minute walk test at 6-months.

Secondary Outcome Measures

Peak Exercise Cardiac Output (Exercise Capacity Addendum)

Peak exercise cardiac output refers to the amount of blood that the heart pumps out per minute. It is an important measure of how effectively the heart is working to deliver oxygen and nutrients to the body's tissues. Peak exercise cardiac output was measured in a cardiac magnetic resonance imaging (MRI) exam.

Arteriovenous Oxygen Difference (A-V O2) (Exercise Capacity Addendum)

Arteriovenous Oxygen Difference (A-V O2) is the difference in oxygen levels between arterial blood and venous blood. A-V O2 difference is important because it reflects how much oxygen is being used by the body's tissues during exercise or physical activity. A higher A-V O2 difference is generally considered better.

Maximum Rate of Oxygen Consumption (VO2) (Exercise Capacity Addendum)

Maximum rate of oxygen consumption (VO2) is an objective measure of cardiorespiratory fitness. VO2 was assessed with a cardiopulmonary exercise test (CPET). Higher VO2 represents greater cardiorespiratory fitness.

Left Ventricular Function (Exercise Capacity Addendum)

Left ventricular ejection fraction (LVEF, %) is a measure of cardiac function. LVEF was assessed with a cardiac magnetic resonance imaging (MRI) exam. The higher the LVEF, the more efficiently the heart is at pumping blood to the rest of the body with every heart beat.

Cognitive Function- Controlled Oral Word Association (COWA) Test (Exercise Capacity Addendum)

The COWA test was used to assess cognitive function and verbal fluency. Participants were asked to produce as many words as they can that begin with the given letter (i.e. T or L) within a 1-min time period. The COWA test total score was measured by summing the total number of acceptable words produced for three different letters. Minimum possible score for the COWA text is 0. There is no maximum possible score. Higher scores represent greater verbal fluency.

Health-Related Quality of Life (Exercise Capacity Addendum)

The Functional Assessment of Cancer Treatment-Lymphoma (FACT-Lym) is a 42-item scale used to assess the health-related quality of life of lymphoma survivors. The FACT-Lym questionnaire examines the four primary domains of HRQL: physical, social, emotional, and functional well-being, and patient's concerns related to lymphoma. The FACT-Lym was examined as a total score, ranging from 0 to 168 points. Higher scores reflect better health-related quality of life.

6-minute Walk Distance (Exercise Capacity Addendum)

The 6-minute walk test is a low cost sub-maximal exercise test that serves as an indirect measure of cardiorespiratory fitness. Participants were instructed to walk at their own pace to cover as much ground (in meters) as possible for 6 minutes.

Functional Assessment of Cancer Therapy - (FACT-Fatigue) (Exercise Capacity Addendum)

The FACT-fatigue is a 13-item scale that has been widely used to assess cancer-related fatigue. The FACT-fatigue questionnaire was scored by summing all 13 items with a reverse point system. This produces a range of 0 to 52, with a higher score indicating better functioning and less fatigue.

Full Information

NCT ID

NCT01719562

First Posted

October 11, 2012

Last Updated

May 17, 2023

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT01719562

Brief Title

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

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

January 1, 2013 (Actual)

Primary Completion Date

March 8, 2022 (Actual)

Study Completion Date

March 8, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Toxicity, Malignant Neoplasm, Breast Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

For the exercise capacity portion of this trial, participants will be randomized to 1 of 2 arms.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ADDENDUM: Physical Activity Intervention

Arm Type

Experimental

Arm Description

Arm Title

ADDENDUM: Healthy Living Instruction Group (Control Arm)

Arm Type

Experimental

Arm Description

Arm Title

MRI (Diagnostic)

Arm Type

Experimental

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Magnetic resonance imaging

Other Intervention Name(s)

MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Physical Activity

Intervention Description

Tailored aerobic exercise program onsite and at home.

Intervention Type

Other

Intervention Name(s)

Healthy Living

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Cardiopulmonary Exercise Testing (CPET)

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Questionnaire Administration

Intervention Description

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

Primary Outcome Measure Information:

Title

Number of Participants Completing the Trial (Exercise Capacity Addendum)

Description

The number of participants who completed the intervention.

Time Frame

6 months after treatment initiation

Title

Number of Participants Able to Complete Assessments (Exercise Capacity Addendum)

Description

Number of participants who completed the 6-minute walk test at 6-months.

Time Frame

6 months after treatment initiation

Secondary Outcome Measure Information:

Title

Peak Exercise Cardiac Output (Exercise Capacity Addendum)

Description

Time Frame

6 months after treatment

Title

Arteriovenous Oxygen Difference (A-V O2) (Exercise Capacity Addendum)

Description

Time Frame

6 months after treatment initiation

Title

Maximum Rate of Oxygen Consumption (VO2) (Exercise Capacity Addendum)

Description

Time Frame

6 months after treatment initiation

Title

Left Ventricular Function (Exercise Capacity Addendum)

Description

Time Frame

6 months after treatment initiation

Title

Cognitive Function- Controlled Oral Word Association (COWA) Test (Exercise Capacity Addendum)

Description

Time Frame

6 months after treatment initiation

Title

Health-Related Quality of Life (Exercise Capacity Addendum)

Description

Time Frame

6 months after treatment initiation

Title

6-minute Walk Distance (Exercise Capacity Addendum)

Description

Time Frame

6 months after treatment initiation

Title

Functional Assessment of Cancer Therapy - (FACT-Fatigue) (Exercise Capacity Addendum)

Description

Time Frame

6 months after treatment initiation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Hundley

Organizational Affiliation

Wake Forest University Health Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Comprehensive Cancer Center of Wake Forest University

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Virginia Commonwealth University Health Sciences

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23284

Country

United States

12. IPD Sharing Statement

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

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