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MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum
NA trial testing Magnetic resonance imaging in Cardiac Toxicity in 28 participants. Completed in 8 March 2022.
| Lead sponsor | Wake Forest University Health Sciences |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 28 |
| Start date | 1 January 2013 |
| Primary completion | 8 March 2022 |
| Estimated completion | 8 March 2022 |
| Sites | 2 locations across United States |
Wake Forest University Health Sciences
Adults 18 to 85, any sex, with Cardiac Toxicity or Malignant Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The number of participants who completed the intervention.
| Group | Value | 95% CI |
|---|---|---|
| ADDENDUM: Physical Activity Intervention | 17 | |
| ADDENDUM: Healthy Living Instruction Group (Control Arm) | 8 |
Number of participants who completed the 6-minute walk test at 6-months.
| Group | Value | 95% CI |
|---|---|---|
| ADDENDUM: Physical Activity Intervention | 14 | |
| ADDENDUM: Healthy Living Instruction Group (Control Arm) | 7 |
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.
| Group | Value | 95% CI |
|---|---|---|
| ADDENDUM: Physical Activity Intervention | 16900 | ± 3350 |
| ADDENDUM: Healthy Living Instruction Group (Control Arm) | 15700 | ± 4100 |
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.
| Group | Value | 95% CI |
|---|---|---|
| ADDENDUM: Physical Activity Intervention | 0.00182 | ± 0.000322 |
| ADDENDUM: Healthy Living Instruction Group (Control Arm) | 0.00150 | ± 0.000362 |
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.
| Group | Value | 95% CI |
|---|---|---|
| ADDENDUM: Physical Activity Intervention | 29.6 | ± 5.83 |
| ADDENDUM: Healthy Living Instruction Group (Control Arm) | 23.6 | ± 10.2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| ADDENDUM: Physical Activity Intervention | 65.3 | ± 8.06 |
| ADDENDUM: Healthy Living Instruction Group (Control Arm) | 65.1 | ± 5.76 |
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.
| Group | Value | 95% CI |
|---|---|---|
| ADDENDUM: Physical Activity Intervention | 46.5 | ± 9.53 |
| ADDENDUM: Healthy Living Instruction Group (Control Arm) | 39.3 | ± 10.6 |
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.
| Group | Value | 95% CI |
|---|---|---|
| ADDENDUM: Physical Activity Intervention | 87.3 | ± 10.3 |
| ADDENDUM: Healthy Living Instruction Group (Control Arm) | 76.6 | ± 13.4 |
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.
| Group | Value | 95% CI |
|---|---|---|
| ADDENDUM: Physical Activity Intervention | 543 | ± 90.6 |
| ADDENDUM: Healthy Living Instruction Group (Control Arm) | 457 | ± 77.0 |
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.
| Group | Value | 95% CI |
|---|---|---|
| ADDENDUM: Physical Activity Intervention | 42.0 | ± 6.20 |
| ADDENDUM: Healthy Living Instruction Group (Control Arm) | 32.4 | ± 8.52 |
Time frame: 6 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | ADDENDUM: Physical Activit… | ADDENDUM: Healthy Living I… |
|---|---|---|---|
| Nausea due to home-based exercise session | Gastrointestinal disorders | — | — |
Data from ClinicalTrials.gov NCT01719562 adverse events section.
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.
7 peer-reviewed publications reference this trial (live from Europe PMC):
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