Clinical trial NCT03923504: Improving Exercise Capacity With Tailored Physical Activity in Lymphoma & Breast Cancer Patients Undergoing Tx
Official title: Improving Exercise Capacity With a Tailored Physical Activity Intervention in Lymphoma and Breast Cancer Patients Undergoing Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hodgkin Lymphoma
Non-hodgkin Lymphoma
Lymphoma
Breast Cancer
Keywords: Physical Activity Intervention
Healthy Living Intervention
Health-related Quality of Life
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Detailed 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).

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.

Primary outcomes:
measure: Assessment of Patient Interest in Protocol
timeFrame: 6 Months
measure: Assessment of Patient Compliance
timeFrame: 6 Months
measure: Assessment of Patient Response to Interventions
timeFrame: 6 Months
Secondary outcomes:
measure: Assessment of Cardiac Output
timeFrame: 6 Months
measure: Assessment of Oxygen Output
timeFrame: 6 Months
measure: Assessment of Health Related Quality of Life
timeFrame: 6 Months
measure: Assessment of Fatigue
timeFrame: 6 Months
measure: Assessment of General Health
timeFrame: 6 Months
measure: Assessment for Anemia
timeFrame: 6 Months
measure: Assessment of Renal Function
timeFrame: 6 Months
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University Massey Cancer Center
state: Virginia
city: South Hill
country: United States
facility: Virginia Commonwealth University Community Memorial Health Center
state: Virginia
Study officials:
affiliation: Massey Cancer Center
name: Alexander Lucas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: