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"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Number of Participants Completing the Trial (Exercise Capacity Addendum)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
ADDENDUM: Healthy Living Instruction Group (Control Arm)
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. .
干预措施: Healthy Living (Other)
ADDENDUM: Healthy Living Instruction Group (Control Arm)
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. .
干预措施: Cardiopulmonary Exercise Testing (CPET) (Device)
ADDENDUM: Healthy Living Instruction Group (Control Arm)
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. .
干预措施: Questionnaire Administration (Other)
MRI (Diagnostic)
Patients undergo MRI scans for LV function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
干预措施: Magnetic resonance imaging (Procedure)
MRI (Diagnostic)
Patients undergo MRI scans for LV function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
干预措施: Physical Activity (Other)
MRI (Diagnostic)
Patients undergo MRI scans for LV function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
干预措施: Healthy Living (Other)
ADDENDUM: Physical Activity Intervention
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.
干预措施: Magnetic resonance imaging (Procedure)
ADDENDUM: Physical Activity Intervention
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.
干预措施: Physical Activity (Other)
ADDENDUM: Physical Activity Intervention
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.
干预措施: Cardiopulmonary Exercise Testing (CPET) (Device)
ADDENDUM: Physical Activity Intervention
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.
干预措施: Questionnaire Administration (Other)
ADDENDUM: Healthy Living Instruction Group (Control Arm)
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. .
干预措施: Magnetic resonance imaging (Procedure)
结局指标
主要结局
Number of Participants Completing the Trial (Exercise Capacity Addendum)
时间窗: 6 months after treatment initiation
The number of participants who completed the intervention.
Number of Participants Able to Complete Assessments (Exercise Capacity Addendum)
时间窗: 6 months after treatment initiation
Number of participants who completed the 6-minute walk test at 6-months.
次要结局
- Arteriovenous Oxygen Difference (A-V O2) (Exercise Capacity Addendum)(6 months after treatment initiation)
- Functional Assessment of Cancer Therapy - (FACT-Fatigue) (Exercise Capacity Addendum)(6 months after treatment initiation)
- Cognitive Function- Controlled Oral Word Association (COWA) Test (Exercise Capacity Addendum)(6 months after treatment initiation)
- 6-minute Walk Distance (Exercise Capacity Addendum)(6 months after treatment initiation)
- Peak Exercise Cardiac Output (Exercise Capacity Addendum)(6 months after treatment)
- Left Ventricular Function (Exercise Capacity Addendum)(6 months after treatment initiation)
- Health-Related Quality of Life (Exercise Capacity Addendum)(6 months after treatment initiation)
- Maximum Rate of Oxygen Consumption (VO2) (Exercise Capacity Addendum)(6 months after treatment initiation)