Improving Exercise Capacity With a Tailored Physical Activity Intervention

Official title

Improving Exercise Capacity With a Tailored Physical Activity Intervention in Lymphoma and Breast Cancer Patients Undergoing Treatment

Overview

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.

Detailed description

Primary Objective: To determine if a \>10% difference exists in the % change (i.e., 2.06 ml/kg/min difference) in peak VO2 (volume or amount of oxygen your body consume) from baseline to 6 months of intervention between participants receiving the Physical Activity Intervention (PAI) versus Healthy Living Intervention (HLI).

Secondary Objectives:

* To determine if a \>10% difference exists in the % change in peak exercise cardiac output, calculated A-VO2 difference, and pre-exercise measures of left ventricular function from baseline to 6 months of intervention between participants receiving the PAI versus HLI. * Among these same participants, 1) to compare PAI and HLI groups on their baseline to 3 \& 6 months after initiating cancer treatment changes in 6-minWD, Health-Related Quality of Life (HRQOL), fatigue, strength, physical activity, cognitive \& physical function, 2) to determine the relationships between the 6-month time-dependent changes in these and peak VO2; and 3) to examine whether time-dependent changes in peak exercise cardiac output and/or calculated arteriovenous oxygen difference are associated with similar time-dependent changes in peak VO2. * Assess physical activity engagement via accelerometry.

Interventions

• Other Exercise with Trainerize application
  1-2 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.
• Diagnostic test Cardiopulmonary exercise testing
  Maximal peak VO2 (to monitor the body's oxygen consumption) and 6-minute exercise walking test.
• Diagnostic test MRI scan
  Images of the heart will be taken.
• Behavioral Quality of Life Questionnaires
  Participants 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.
• Behavioral Cognitive and Brain Function Questionnaires
  Participants 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.
• Other Blood draws
  Approximately 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.

Primary outcome measures

• Change in Peak VO2 [Time frame: At baseline and 6 months after study intervention]

Secondary outcome measures (12)

• Change in Peak Exercise Cardiac Output [Time frame: At baseline and 6 months after study intervention]
• Change in Calculated A-V Oxygen Levels [Time frame: At baseline and 6 months after study intervention]
• Changes in Measurements of Pre-exercise Left Ventricular Function [Time frame: At baseline and 6 months after study intervention]
• Change in Neurocognitive Function - Hopkins Verbal Learning Test [Time frame: At baseline and 6 months after study intervention]
• Change in Neurocognitive Function - Controlled Oral Word Association Test (COWAT) [Time frame: At baseline and 6 months after study intervention]
• Change in Neurocognitive Function - Digit Span-Backward Test [Time frame: At baseline and 6 months after study intervention]
• Change in Neurocognitive Function - Trail Making Test [Time frame: At baseline and 6 months after study intervention]
• Change in 6-Minute Walk Distance [Time frame: At baseline, 3 months and 6 months after study intervention]
• Health-Related Quality of Life Questionnaire (FACT-Lym or FACT-B) [Time frame: At baseline, 3 months and 6 months after study intervention]
• Fatigue Questionnaire [Time frame: At baseline, 3 months and 6 months after study intervention]
• Change in Physical Activity Levels - Godin Leisure Time Exercise Questionnaire [Time frame: At baseline, 3 months and 6 months after study intervention]
• Change in Physical Function - Balance Test [Time frame: At baseline, 3 months and 6 months after study intervention]

Eligibility criteria

Inclusion criteria

To be considered eligible, participants must meet all of the following criteria:

• 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
• Capacity to walk at least 2 city blocks (\~.2 miles) on a flat surface
• Expected survival beyond 6 months.
• Must have an assistant that will help perform the home-based testing activities

Exclusion criteria

If the patient meets any of these criteria they are excluded from the study:

• 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
• Unstable angina
• Contraindication for exercise training or testing
• 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
• Inability to provide informed consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 2 centers

• Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem
• Virginia Commonwealth University — Richmond

Identifiers

NCT: NCT05595577 · IRB00087763 · 4R33CA226960-03 · WFBCCC 98622

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗