MRI in Detecting Heart Damage in Patients With Cancer Receiving Chemotherapy With Exercise Capacity Addendum

NCT01719562 | Completed Results FDA Device

• 6 other identifiers: IRB00020968NCI-2012-01613P30CA012197CCCWFU 99112R01CA167821R21CA226960
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

Brief Summary

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

Cardiac Toxicity; Malignant Neoplasm; Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Number of Participants Completing the Trial (Exercise Capacity Addendum)

  The number of participants who completed the intervention.

  6 months after treatment initiation

• Number of Participants Able to Complete Assessments (Exercise Capacity Addendum)

  Number of participants who completed the 6-minute walk test at 6-months.

  6 months after treatment initiation

Secondary Outcomes (8)

• Peak Exercise Cardiac Output (Exercise Capacity Addendum)

  6 months after treatment

• Arteriovenous Oxygen Difference (A-V O2) (Exercise Capacity Addendum)

  6 months after treatment initiation

• Maximum Rate of Oxygen Consumption (VO2) (Exercise Capacity Addendum)

  6 months after treatment initiation

• Left Ventricular Function (Exercise Capacity Addendum)

  6 months after treatment initiation

• Cognitive Function- Controlled Oral Word Association (COWA) Test (Exercise Capacity Addendum)

  6 months after treatment initiation

Study Arms (3)

ADDENDUM: Physical Activity Intervention

EXPERIMENTAL

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.

Procedure: Magnetic resonance imaging; Other: Physical Activity; Device: Cardiopulmonary Exercise Testing (CPET); Other: Questionnaire Administration

ADDENDUM: Healthy Living Instruction Group (Control Arm)

EXPERIMENTAL

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. .

Procedure: Magnetic resonance imaging; Other: Healthy Living; Device: Cardiopulmonary Exercise Testing (CPET); Other: Questionnaire Administration

MRI (Diagnostic)

EXPERIMENTAL

Patients undergo MRI scans for LV function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.

Procedure: Magnetic resonance imaging; Other: Physical Activity; Other: Healthy Living

Interventions

Magnetic resonance imaging PROCEDURE

Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.

Also known as: MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging

ADDENDUM: Healthy Living Instruction Group (Control Arm); ADDENDUM: Physical Activity Intervention; MRI (Diagnostic)

Physical Activity OTHER

Tailored aerobic exercise program onsite and at home.

ADDENDUM: Physical Activity Intervention; MRI (Diagnostic)

Healthy Living OTHER

Healthy living presentations at a centralized meeting place and over the phone.

ADDENDUM: Healthy Living Instruction Group (Control Arm); MRI (Diagnostic)

Cardiopulmonary Exercise Testing (CPET) DEVICE

Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.

ADDENDUM: Healthy Living Instruction Group (Control Arm); ADDENDUM: Physical Activity Intervention

Questionnaire Administration OTHER

A self-administered 13-item scale to assess fatigue in participants

ADDENDUM: Healthy Living Instruction Group (Control Arm); ADDENDUM: Physical Activity Intervention

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

Virginia Commonwealth University Health Sciences

Richmond, Virginia, 23284, United States

Location

Related Publications (3)

• Costa 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 DERIVED

• Mabudian 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 DERIVED

• Garg 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 DERIVED

MeSH Terms

Conditions

Cardiotoxicity; Neoplasms; Breast Neoplasms

Interventions

Magnetic Resonance Spectroscopy; Exercise; Exercise Test

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry

Results Point of Contact

• Title: Project Manager
• Organization: Wake Forest University

jvolpini@wakehealth.edu

+1(336) 758-3728

Study Officials

• William Hundley

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: For the exercise capacity portion of this trial, participants will be randomized to 1 of 2 arms.

Study Record Dates

• First Submitted: October 11, 2012
• First Posted: November 1, 2012
• Study Start: January 1, 2013
• Primary Completion: March 8, 2022
• Study Completion: March 8, 2022
• Last Updated: May 19, 2023
• Results First Posted: May 16, 2023

Record last verified: 2023-05

Locations

US (2)