Non Hodgkin Lymphoma Clinical Trial

Improving Exercise Capacity With a Tailored Physical Activity Intervention

Summary

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.

View Full Description

Full 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.

View Eligibility Criteria

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
Expected 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 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)
Claustrophobia
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

Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

66

Study ID:

NCT05595577

Recruitment Status:

Not yet recruiting

Sponsor:

Wake Forest University Health Sciences

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 2 Locations for this study

See Locations Near You

Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem North Carolina, 27157, United States More Info
W G Hundley, MD
Principal Investigator
Virginia Commonwealth University
Richmond Virginia, 23298, United States More Info
W. G. Hundley, MD
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

66

Study ID:

NCT05595577

Recruitment Status:

Not yet recruiting

Sponsor:


Wake Forest University Health Sciences

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.