Clinical trial · Interventional
MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum
Improving Exercise Capacity With a Tailored Physical Activity Intervention in Lymphoma and Breast Cancer Patients Undergoing Treatment - An Addendum to NIH R01CA167821 "Early Imaging Detection of Cardiovascular Injury After Cancer"
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial studies how well magnetic resonance imaging (MRI) works in detecting heart damage in patients with cancer receiving chemotherapy. Diagnostic procedures, such as MRI, may help doctors predict whether patients will have heart damage caused by chemotherapy in patients with cancer receiving chemotherapy. Exercise Capacity Addendum Brief Summary: This study is designed to demonstrate feasibility of performing the physical activity intervention and the primary outcome measures before, during and six months after initiating Anth-bC for treatment of non- or Hodgkin lymphoma. This study will test the potential for a novel (lifestyle) intervention designed to improve exercise capacity, health-related quality of life and cardiac and cognitive dysfunction. This data will inform the development of the R33 phase of the clinical trial to determine if the physical activity intervention can reduce exercise intolerance in this high-risk population. In addition, cardiac MRI data from individuals within this pilot will be compared to cardiac MRI data from individuals in the parent study that did not undergo either of the two interventional arms of this study.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cardiac Toxicity | — | UNRESOLVED | — |
| Malignant Neoplasm | Malignant Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cardiopulmonary Exercise Testing (CPET) | Device | — | UNRESOLVED |
| Healthy Living | Other | — | UNRESOLVED |
| Magnetic resonance imaging | Procedure | — | UNRESOLVED |
| Physical Activity | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- ADDENDUM: Physical Activity Intervention
- description
- Participants will be offered one to two training sessions per week at onsite rehab facilities and 1-2 sessions per week at home consisting of slow 15 minute aerobic warm-up followed by 20 minutes of strength training, 15 minutes of progressive intensity aerobic exercise and 10 minute cool down.
- interventionNames
- Procedure: Magnetic resonance imaging
- Other: Physical Activity
- Device: Cardiopulmonary Exercise Testing (CPET)
- Other: Questionnaire Administration
- type
- EXPERIMENTAL
- label
- ADDENDUM: Healthy Living Instruction Group (Control Arm)
- description
- Organized various health workshops lasting for 60 minutes to match the number of visits to the rehab centers for participants in Arm 1 with 2 sessions offered per month onsite and remaining sessions offered over the phone for 6 months. .
- interventionNames
- Procedure: Magnetic resonance imaging
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
PARENT STUDY: Inclusion Criteria: * Receiving \>= 350 mg/m\^2 of Anth-bC therapy, or a combination of Anth-bC (\>= 250 mg/m\^2) and subsequent paclitaxel or Herceptin * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices, or other implanted electronic devices * Ferromagnetic cerebral aneurysm clips, or other intraorbital/intracranial metal * Allergy to gadolinium or other severe drug allergies * Unstable angina * Significant ventricular arrhythmias (\> 20 premature ventricular contractions \[PVCs\]/minute due to gating difficulty) * Acute myocardial infarction within 28 days * Atrial fibrillation with uncontrolled ventricular response * Moderate or severe aortic stenosis * Claustrophobia * Congestive heart failure (New York Heart Association \[NYHA\] class III or IV) * Significant valvular disease, or significant pulmonary disease requiring supplemental oxygen therapy * Participants unwilling to complete the protocol (24 month duration) * Women who are pregnant * Patients unable or unwilling to provide informed consent EXERCISE CAPACITY ADDENDUM: Inclusion Criteria: * Men and women aged 18-85 with non- or Hodgkin lymphoma or I-IV stage breast cancer patients that expect 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). * Potential enrollees will need the capacity to walk at least two (2) city blocks on a flat surface. * English speaking participants only will be enrolled. * Stage IV breast cancer participants must have a 2 year survival prognosis and approval from their physician. Exclusion Criteria: The following are relative contraindications and can be considered by the medical director of the study: * Uncontrolled hypertension (systolic blood pressure \>190 mm Hg or diastolic blood pressure \>100 mm Hg) * A 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. * Other exclusions include those with contraindications to MRI such as ferromagnetic cerebral aneurysm clips or other intracranial metal, pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices. * Unstable angina. * 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. * Moving within 12 months of enrollment.
References
Publications (4)
- DERIVEDLeitzelar BN, Costa JV, Aguilar AA, Wolle BR, Lucas AR, Marshall A, Norton S, Mihalko SL, Brubaker PH, Vaidya R, Seegars MB, Yazbeck V, Franco RL, Via J, Hundley WG, Wagner LI. Qualitative Study of Breast Cancer and Lymphoma Patients Participating in a Physical Activity Intervention: The Case for Tailored Physical Activity. Cancer Med. 2026 Mar;15(3):e71747. doi: 10.1002/cam4.71747. PMID 41877348
- DERIVEDCosta JV, Lucas AR, Mihalko SL, Brubaker PH, Marshall A, Leitzelar B, Wolle BR, Norton S, Franco RL, Via J, Yazbeck V, Vaidya R, Seegars MB, D'Agostino R Jr, Wagner L, Hundley WG. Feasibility and preliminary efficacy of a physical activity intervention in adults with lymphoma undergoing treatment. Pilot Feasibility Stud. 2025 Jan 14;11(1):6. doi: 10.1186/s40814-024-01580-7. PMID 39810280
- DERIVEDMabudian L, Reding K, D'Agostino RB Jr, Heiston EM, Bellissimo MP, Olson K, Ntim WO, Klepin HD, Dressler EV, Moore T, Jordan JH, O'Connell NS, Ladd A, Weaver KE, Ky B, Wagner LI, Hackney MH, Lesser GJ, Hundley WG; UPBEAT Study Team. The relationship between body composition and left ventricular performance in women with breast, lymphoma, or sarcoma cancer. Cardiooncology. 2024 Jun 6;10(1):34. doi: 10.1186/s40959-024-00233-1. PMID 38845066
- DERIVEDGarg R, D'Agostino RB Jr, O'Connell N, Lesser GJ, Salloum FN, Hines AL, Melendez GC, Jordan JH, Ky B, Wagner LI, Sutton AL, Bottinor W, Olson KC, Ladd AC, Hundley WG; UPBEAT Study Team. Hypertension Severity and Declines in Left Ventricular Ejection Fraction Among Women Receiving Adjuvant Chemotherapy for Breast Cancer (WF-97415 UPBEAT). Hypertension. 2024 Jun;81(6):1365-1373. doi: 10.1161/HYPERTENSIONAHA.123.21817. Epub 2024 Apr 18. PMID 38634292