N/A
N=28
MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum
Cardiac Toxicity · Malignant Neoplasm · Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01719562 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Number of Participants Completing the Trial (Exercise Capacity Addendum) — 17; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Magnetic resonance imaging (Procedure); Physical Activity (Other); Healthy Living (Other); Cardiopulmonary Exercise Testing (CPET) (Device); Questionnaire Administration (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Completing the Trial (Exercise Capacity Addendum) |
17; 8 | — |
| PRIMARY Number of Participants Able to Complete Assessments (Exercise Capacity Addendum) |
14; 7 | — |
| SECONDARY Peak Exercise Cardiac Output (Exercise Capacity Addendum) |
16900; 15700 | — |
| SECONDARY Arteriovenous Oxygen Difference (A-V O2) (Exercise Capacity Addendum) |
0.00182; 0.00150 | — |
| SECONDARY Maximum Rate of Oxygen Consumption (VO2) (Exercise Capacity Addendum) |
29.6; 23.6 | — |
| SECONDARY Left Ventricular Function (Exercise Capacity Addendum) |
65.3; 65.1 | — |
| SECONDARY Cognitive Function- Controlled Oral Word Association (COWA) Test (Exercise Capacity Addendum) |
46.5; 39.3 | — |
| SECONDARY Health-Related Quality of Life (Exercise Capacity Addendum) |
87.3; 76.6 | — |
| SECONDARY 6-minute Walk Distance (Exercise Capacity Addendum) |
543; 457 | — |
| SECONDARY Functional Assessment of Cancer Therapy - (FACT-Fatigue) (Exercise Capacity Addendum) |
42.0; 32.4 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01719562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.