Breast Cancer Clinical Trial

Improving Exercise Capacity With Tailored Physical Activity in Lymphoma & Breast Cancer Patients Undergoing Tx

Summary

To provide critical participant enrollment data necessary to complete a larger definitive clinical trial in the future.

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Full Description

This study is a 2-arm, parallel design, single-blind randomized controlled pilot study designed to compare the effects of a tailored multi-level physical activity intervention (PAI) vs healthy living intervention (HLI) on exercise capacity, cardiovascular and cognitive function, health-related quality of life (QOL), strength and fatigue among lymphoma and breast cancer patients undergoing active treatment with anthracycline based chemotherapy (anthra-bC).

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Eligibility Criteria

Inclusion Criteria:

Subjects age 18-85 years old
Stage I-IV Hodgkin's (HL) or Non-Hodgkin's Lymphoma (NHL) or I-III Breast Cancer patients who are receiving (within 6 weeks of initiation) or are scheduled to receive potentially cardiotoxic systemic therapies (e.g. chemotherapy regimens [anthracyclines, trastuzumab]), immuno-therapies (immune checkpoint inhibitors [ICI's]), hormonal therapies (aromatase inhibitors) or radiation (within 8 weeks of completion).

Exclusion Criteria:

Evidence of COVID19 within the last 60 days or recent (21 days) exposure to close personal contact who has tested positive for COVID19.
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; 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; claustrophobia; pregnancy; those unable to provide informed consent (able to read and write English); or moving within 12 mos. of enrollment.

Study is for people with:

Breast Cancer

Estimated Enrollment:

12

Study ID:

NCT03923504

Recruitment Status:

Completed

Sponsor:

Virginia Commonwealth University

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There are 2 Locations for this study

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Virginia Commonwealth University Massey Cancer Center
Richmond Virginia, 23298, United States
Virginia Commonwealth University Community Memorial Health Center
South Hill Virginia, 23970, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

12

Study ID:

NCT03923504

Recruitment Status:

Completed

Sponsor:


Virginia Commonwealth University

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