Exercise in Breast Cancer Survivors
The investigators hypothesize that exercise in postmenopausal breast cancer survivors will result in an increase in the plasma concentrations of angiostatic factors and a decrease in the plasma concentrations of angiogenic factors. Exercise is expected to result in a circulating angiostatic phenotype that inhibits adipose tissue mass, growth of breast cancer tumor, growth of microscopic residual disease after breast cancer resection, decreases rates of local-regional recurrence, decreases rates of distant recurrence, and increases survival.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
|Official Title:||Exercise in Breast Cancer Survivors: Analysis of Angiogenic Profile|
- Number of participants that complete the study as a measure of feasibility of an exercise intervention in obese breast cancer survivors. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]Number of participants that enroll in the study and actually complete the study
- IGF-1, endostatin, and VEGF levels in obese breast cancer survivors undergoing an exercise intervention as a measure of angiostatic phenotype: [ Time Frame: 12 months ] [ Designated as safety issue: No ]IFG-1 levels,unbound VEGF levels, Endostatin levels
- Amount of adipose tissue mass as measured on CT scans in obese breast cancer survivors before and after exercise intervention as a measure of weight loss [ Time Frame: 12 months ] [ Designated as safety issue: No ]Adipose tissue mass volume as measured on CT scan
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||April 2013|
|Estimated Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Experimental: Exercise Group
The intervention is a structured walking program which will be performed partly in the Pavilion Physical Therapy clinic and partly at home. The participant will be instructed in how hard to exercise, how long to exercise, and how many times in a week to exercise. You will also be instructed in how to exercise safely.
The participant will exercise for 16 weeks under supervision. The exercise regimen is increased slowly over 16 weeks.
No Intervention: No Exercise
These participants will receive standard of care follow up.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01582685
|Contact: Natale Sheehan, MDfirstname.lastname@example.org|
|United States, Mississippi|
|University of Mississippi Health Care||Recruiting|
|Jackson, Mississippi, United States, 39216|
|Contact: Natale Sheehan, MD 601-984-5590 email@example.com|
|Principal Investigator: Natal Sheehan, MD|
|Principal Investigator:||Natale Sheehan, MD||University of Mississippi Health Care|