AzTrials
AzTrials

Cardiac ToxicityNCT01719562

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

A study testing Magnetic resonance imaging, Physical Activity and Healthy Living in people with Cardiac Toxicity and Malignant Neoplasm, run by Wake Forest University Health Sciences at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Magnetic resonance imaging, Physical Activity and Healthy Living
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
2 sitesUnited States
Study dates
1 Jan 2013to 8 Mar 2022
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
  • 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.
Show all 17Show fewer
  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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:

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Virginia Commonwealth University Health Sciences

    Richmond, Virginia, 23284

  • Comprehensive Cancer Center of Wake Forest University

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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"

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.
Being tested
Magnetic resonance imaging, Physical Activity, Healthy Living, Cardiopulmonary Exercise Testing (CPET), Questionnaire Administration
Medical subject headings
Cardiotoxicity, Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnetic resonance imagingProcedure or surgery

    Also called MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

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

  • Physical ActivityOther

    Tailored aerobic exercise program onsite and at home.

  • Healthy LivingOther

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

  • Cardiopulmonary Exercise Testing (CPET)Device

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

  • Questionnaire AdministrationOther

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

Study groups in NCT01719562
Study groupRoleWhat they receive
ADDENDUM: Physical Activity InterventionExperimentalParticipants 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.
Receives: Procedure: Magnetic resonance imaging; Other: Physical Activity; Device: Cardiopulmonary Exercise Testing (CPET); Other: Questionnaire Administration
ADDENDUM: Healthy Living Instruction Group (Control Arm)ExperimentalOrganized 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. .
Receives: Procedure: Magnetic resonance imaging; Other: Healthy Living; Device: Cardiopulmonary Exercise Testing (CPET); Other: Questionnaire Administration
MRI (Diagnostic)ExperimentalPatients undergo MRI scans for LV function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
Receives: Procedure: Magnetic resonance imaging; Other: Physical Activity; Other: Healthy Living

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Completing the Trial (Exercise Capacity Addendum)

    The number of participants who completed the intervention.

    Measured: 6 months after treatment initiation

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

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

    Measured: 6 months after treatment initiation

Secondary outcomes (8)

  1. 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.

    Measured: 6 months after treatment

  2. 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.

    Measured: 6 months after treatment initiation

  3. 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.

    Measured: 6 months after treatment initiation

  4. 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.

    Measured: 6 months after treatment initiation

  5. 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.

    Measured: 6 months after treatment initiation

  6. 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.

    Measured: 6 months after treatment initiation

  7. 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.

    Measured: 6 months after treatment initiation

  8. 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.

    Measured: 6 months after treatment initiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2012 (estimated)
  2. Study start1 Jan 2013
  3. Primary completion8 Mar 2022
  4. Study completion8 Mar 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Model description
For the exercise capacity portion of this trial, participants will be randomized to 1 of 2 arms.
Masking
None (open label)
Enrolment
28 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01719562
Sponsor's protocol ID
IRB00020968
Other IDs
NCI-2012-01613, P30CA012197, CCCWFU 99112, R01CA167821, R21CA226960
Status last verified
May 2023
First submitted
11 Oct 2012
Last updated
19 May 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Leitzelar BN, Costa JV, Aguilar AA, Wolle BR, Lucas AR, Marshall A, Norton S, Mihalko SL, Brubaker PH, Vaidya R, Seegars MB, Yazbeck V, Franco RL, Via J, Hundley WG, Wagner LI. Qualitative Study of Breast Cancer and Lymphoma Patients Participating in a Physical Activity Intervention: The Case for Tailored Physical Activity. Cancer Med. 2026 Mar;15(3):e71747. doi: 10.1002/cam4.71747.

    PubMed 41877348

  • Costa JV, Lucas AR, Mihalko SL, Brubaker PH, Marshall A, Leitzelar B, Wolle BR, Norton S, Franco RL, Via J, Yazbeck V, Vaidya R, Seegars MB, D'Agostino R Jr, Wagner L, Hundley WG. Feasibility and preliminary efficacy of a physical activity intervention in adults with lymphoma undergoing treatment. Pilot Feasibility Stud. 2025 Jan 14;11(1):6. doi: 10.1186/s40814-024-01580-7.

    PubMed 39810280

  • Mabudian L, Reding K, D'Agostino RB Jr, Heiston EM, Bellissimo MP, Olson K, Ntim WO, Klepin HD, Dressler EV, Moore T, Jordan JH, O'Connell NS, Ladd A, Weaver KE, Ky B, Wagner LI, Hackney MH, Lesser GJ, Hundley WG; UPBEAT Study Team. The relationship between body composition and left ventricular performance in women with breast, lymphoma, or sarcoma cancer. Cardiooncology. 2024 Jun 6;10(1):34. doi: 10.1186/s40959-024-00233-1.

    PubMed 38845066

  • Garg R, D'Agostino RB Jr, O'Connell N, Lesser GJ, Salloum FN, Hines AL, Melendez GC, Jordan JH, Ky B, Wagner LI, Sutton AL, Bottinor W, Olson KC, Ladd AC, Hundley WG; UPBEAT Study Team. Hypertension Severity and Declines in Left Ventricular Ejection Fraction Among Women Receiving Adjuvant Chemotherapy for Breast Cancer (WF-97415 UPBEAT). Hypertension. 2024 Jun;81(6):1365-1373. doi: 10.1161/HYPERTENSIONAHA.123.21817. Epub 2024 Apr 18.

    PubMed 38634292

Questions about this trial

What is this clinical trial studying?

A study testing Magnetic resonance imaging, Physical Activity and Healthy Living in people with Cardiac Toxicity and Malignant Neoplasm, run by Wake Forest University Health Sciences at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Completing the Trial (Exercise Capacity Addendum) (time frame: 6 months after treatment initiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01719562, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in