CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 28 enrolled
Drug / intervention
Magnetic resonance imaging +4 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01719562
NCT01719562N/ACompleted

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"

Wake Forest University Health Sciences·interventional·Posted Nov 1, 2012·Updated May 19, 2023

In Brief

A clinical study evaluating Magnetic resonance imaging, Physical Activity, and 3 other interventions for Cardiac Toxicity and 2 related conditions. Completed, enrolled 28 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 1, 2012
Enrollment StartJan 1, 2013
Primary CompletionMar 8, 2022
TodayJul 2, 2026
Enrollment to primary: 9.2 yearsPosted 13.7 years ago

Interventions

Magnetic resonance imagingprocedure

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

Physical Activityother

Tailored aerobic exercise program onsite and at home.

Healthy Livingother

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

Cardiopulmonary Exercise Testing (CPET)device

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

Questionnaire Administrationother

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