Clinical trial NCT05595577: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Non Hodgkin Lymphoma
Heart; Functional Disturbance
Hodgkin Lymphoma
Quality of Life
Stage I Breast Cancer
Stage II Breast Cancer
Stage III Breast Cancer
Keywords: Exercise capability
Brain activity
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-10-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

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

Primary outcomes:
measure: Change in Peak VO2
timeFrame: At baseline and 6 months after study intervention
Secondary outcomes:
measure: Change in Peak Exercise Cardiac Output
timeFrame: At baseline and 6 months after study intervention
measure: Change in Calculated A-V Oxygen Levels
timeFrame: At baseline and 6 months after study intervention
measure: Changes in Measurements of Pre-exercise Left Ventricular Function
timeFrame: At baseline and 6 months after study intervention
measure: Change in Neurocognitive Function - Hopkins Verbal Learning Test
timeFrame: At baseline and 6 months after study intervention
measure: Change in Neurocognitive Function - Controlled Oral Word Association Test (COWAT)
timeFrame: At baseline and 6 months after study intervention
measure: Change in Neurocognitive Function - Digit Span-Backward Test
timeFrame: At baseline and 6 months after study intervention
measure: Change in Neurocognitive Function - Trail Making Test
timeFrame: At baseline and 6 months after study intervention
measure: Change in 6-Minute Walk Distance
timeFrame: At baseline, 3 months and 6 months after study intervention
measure: Health-Related Quality of Life Questionnaire (FACT-Lym or FACT-B)
timeFrame: At baseline, 3 months and 6 months after study intervention
measure: Fatigue Questionnaire
timeFrame: At baseline, 3 months and 6 months after study intervention
measure: Change in Physical Activity Levels - Godin Leisure Time Exercise Questionnaire
timeFrame: At baseline, 3 months and 6 months after study intervention
measure: Change in Physical Function - Balance Test
timeFrame: At baseline, 3 months and 6 months after study intervention
measure: Change in Physical Function - Chair Stand Test
timeFrame: At baseline, 3 months and 6 months after study intervention
measure: Change in Physical Function - 4-Meter Walk Gait Speed Test
timeFrame: At baseline, 3 months and 6 months after study intervention
measure: Change in Physical Function - Grip Strength
timeFrame: At baseline, 3 months and 6 months after study intervention
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Wake Forest Baptist Comprehensive Cancer Center
name: William Hundley, MD
role: PRINCIPAL_INVESTIGATOR
References: