Improving exercise capacity through tailored physical activity and education
Improving Exercise Capacity With a Tailored Physical Activity Intervention in Lymphoma and Breast Cancer Patients Undergoing Treatment
NA · Wake Forest University Health Sciences · NCT05595577
This study is testing if a program that includes physical activity can help cancer patients improve their exercise ability and overall health better than just attending health workshops.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences (other) |
| Drugs / interventions | trastuzumab, rituximab, chemotherapy, radiation |
| Locations | 2 sites (Winston-Salem, North Carolina and 1 other locations) |
| Trial ID | NCT05595577 on ClinicalTrials.gov |
What this trial studies
This research aims to evaluate the effectiveness of a physical activity intervention compared to health workshops in preserving exercise capability, heart function, brain activity, and quality of life for cancer patients. Participants will be randomized into two groups: one receiving organized health workshops focused on nutrition and lifestyle management, and the other engaging in moderate physical activity sessions. The study will measure changes in peak oxygen consumption and other health-related metrics over a six-month period. The goal is to determine if the physical activity intervention leads to significant improvements compared to the educational approach.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18-85 diagnosed with stage I-IV Hodgkin's or non-Hodgkin's lymphoma or stage I-III breast cancer who are expected to receive potentially cardiotoxic therapies.
Not a fit: Patients with uncontrolled hypertension or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could enhance exercise capacity and overall quality of life for cancer patients undergoing treatment.
How similar studies have performed: Other studies have shown positive outcomes with physical activity interventions in cancer care, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Winston-Salem, North Carolina and 1 other locations
- Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (RECRUITING)
- Virginia Commonwealth University — Richmond, Virginia, United States (RECRUITING)
Study contacts
- Principal investigator: William Hundley, MD — Wake Forest Baptist Comprehensive Cancer Center
- Study coordinator: Study Coordinator
- Email: johnkc22@wfu.edu
- Phone: 336-758-3027
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Non Hodgkin Lymphoma, Heart, Functional Disturbance, Hodgkin Lymphoma, Quality of Life, Stage I Breast Cancer, Stage II Breast Cancer, Stage III Breast Cancer