About this trial
The purpose of this research is to test whether participating in either a physical activity intervention or a series of educational classes will help to preserve exercise capability, heart function, brain-based activities (like memory), and quality of life.
Participants will be randomized to 1 of 2 pathways:
* First pathway consists of organized health workshops. These workshops are intended to provide information on topics such as proper nutrition, management of stress, sleep practices, and emphasis on a healthy lifestyle that may help the participants through cancer treatment. This pathway will also test whether stretching may help participants through cancer treatment. * Second pathway participants will take part in some unsupervised and some potentially supervised moderate activity sessions each week throughout participants' cancer treatment to take place either remotely or in person, depending on availability of facilities at the time visits are scheduled.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Individuals aged 18- 85 years
Diagnosed with stage I-IV Hodgkin's or non-Hodgkin's lymphoma or stage I-III breast cancer
Expected to receive an anthracycline based chemotherapeutic regimen or other potentially cardiotoxic cancer therapies (e.g. chemotherapy regimens [anthracyclines, trastuzumab, rituximab]), immuno-therapies (immune checkpoint inhibitors [ICI's]) or radiation (within 8 weeks of completion of radiation).29-31
Ability to speak and understand English
Disqualifiers
Uncontrolled hypertension (systolic blood pressure >190 mm Hg or diastolic blood pressure >100 mm Hg)
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 (unless approved by the participant's physician and the Principal Investigator) NOTE: In the setting of active inflammation, participation will not be approved. If chronic disease is present and stable as judged by the participant's physician and the PI, participation will be approved.
Contraindications to MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices (unless approved by the participant's physician and the Principal Investigator)
Pregnant
Trial design
Parallel
Treatments tested in this trial
Exercise with Trainerize application
Other intervention1-2 sessions per week consisting of slow 15 minute aerobic warm, 20 minutes of strength training, 15 minutes progressive intensity aerobic exercise and 10 minute cool down (stretching/toning) with elastic bands.
Cardiopulmonary exercise testing
Diagnostic testMaximal peak VO2 (to monitor the body's oxygen consumption) and 6-minute exercise walking test.
MRI scan
Diagnostic testImages of the heart will be taken.
Quality of Life Questionnaires
BehavioralParticipants will be asked to complete several questionnaires that will measure fatigue, general health, social determinants of health, cognitive function (tasks that assess memory, ability to count, etc.) and physical activity. The questionnaires will take 15-40 minutes to complete.
Cognitive and Brain Function Questionnaires
BehavioralParticipants will be asked to complete several questionnaires that will measure fatigue, general health, social determinants of health, cognitive function (tasks that assess memory, ability to count, etc.) and physical activity. The questionnaires will take 15-40 minutes to complete.
Blood draws
Other interventionApproximately 2 teaspoons of blood withdrawn from either a vein in your arm or a currently placed central line port-a-cath. A portion of blood from each visit will be used to collect information about blood cell count.
Treatment groups
Trial outcomes
Primary outcomes
Change in Peak VO2
An analysis of covariance (ANCOVA) model will be used to assess post-intervention group differences in VO2, adjusted for baseline peak VO2.
Secondary outcomes
Change in Peak Exercise Cardiac Output
Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach.
Change in Calculated A-V Oxygen Levels
Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach.
Changes in Measurements of Pre-exercise Left Ventricular Function
Measured on a continuous scale and will be analyzed using a repeated measures ANCOVA (RMANCOVA) approach.
Change in Neurocognitive Function - Hopkins Verbal Learning Test
The Hopkins Verbal Learning Test (HVLT-R) consists of memorization of a list of words to test the ability to recall immediately after memorization (immediate recall) and after a 20-minute delay (delayed recall). This test has three parts and two alternate forms. Total scores could range from 0 to 30. Lower raw scores indicate difficulties with the task.
Sponsors and contacts
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Wake Forest University Health Sciences
Lead sponsor
National Cancer Institute (NCI)
Collaborator