Clinical trial NCT02328313: Impact of Physical Activity on Biomarker of Aging and Body Composition Among Breast Cancer Survivors Age 65 and Older
Official title: LCCC 1410: Impact of Physical Activity on Biomarker of Aging and Body Composition Among Breast Cancer Survivors Age 65 and Older
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Aging
Physical Activity
Keywords: Cancer
Breast Cancer
Geriatric
Advance Age
Exercise
Physical Activity
Genetic Marker
p16
Chemotherapy
Breast Cancer Treatment
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 134
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: To determine if exercise will affect the increase in p16 expression that is associated with both chemotherapy administration and advancing age.

Detailed description: LCCC1410 is designed to compare the change in p16 from baseline to end of chemotherapy in 100 older (≥ 65 years) breast cancer patients participating in a home-based physical activity program (intervention group) to 100 patients in the concurrent control group not participating in a physical activity intervention (enrolled in a separate RO1 study as described in section 1.7). The biomarker p16 is known to dramatically increase with chemotherapy, and we hypothesize that the increase will be attenuated by a physical activity intervention. We will evaluate changes in p16 between the two study populations. Data from the geriatric assessment at baseline will be used to characterize the study population, and subscale scores from the GA will also be assessed for differences between baseline and end of chemotherapy to compare the LCCC1410 study population with the concurrent control.

Eligibility criteria: Inclusion Criteria:

* Age 65 or older, female
* Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis)
* Scheduled to begin an appropriate adjuvant or neoadjuvant chemotherapy regimen as defined by NCCN guidelines (www.nccn.org)
* English speaking
* IRB approved, signed written informed consent
* Approval from their treating physician to engage in moderate-intensity physical activity
* Patient-assessed ability to walk and engage in moderate physical activity
* Willing and able to meet all study requirements.

Exclusion Criteria:

- One or more significant medical conditions that in the physician's judgment preclude participation in the walking intervention.

Primary outcomes:
measure: To measure the change in level of p16 expression from baseline to end of chemotherapy to a control group
timeFrame: 12 months
measure: To measure the changes in the level of p16 expression from baseline and end of chemotherapy.
timeFrame: 2 - 6 months
Secondary outcomes:
measure: To measure changes in body compositional aspects of lean body mass (LBM)
timeFrame: 12 months
measure: To measure changes in body compositional aspects of fat tissue mass (FM)
timeFrame: 12 months
measure: To measure changes in body compositional aspects of percentage body fat (BF)
timeFrame: 12 months
measure: To measure change in physical activity over the course of the study
timeFrame: 12 months
measure: To measure change in physical function over the course of the study
timeFrame: 12 months
measure: To measure change in fatigue over the course of the study
timeFrame: 12 months
measure: To measure change in quality of life over the course of the study
timeFrame: 12 months
measure: To measure change in self-efficacy over the course of the study
timeFrame: 12 months
measure: To measure retention during the study
timeFrame: 12 months
measure: To measure safety of the walking program
timeFrame: 12 months
measure: To measure overall satisfaction with the program
timeFrame: 12 months
measure: To average the number of daily and weekly steps per participant
timeFrame: 12 months
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Amy Garrett
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Hyman Muss, MD
role: PRINCIPAL_INVESTIGATOR
References: