Breast Cancer, Obesity
Conditions
Keywords
Breast Cancer, Obesity, Exercise, Angiogenesis
Brief summary
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.
Interventions
BEHAVIORALExercise
The participant will exercise for 16 weeks under supervision. The exercise regimen is increased slowly over 16 weeks.
Sponsors
University of Mississippi Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \> 18 years of age and \< 65 years of age * Female * BMI \> 25 * Weight \< 350 pounds * English as a primary language * Postmenopausal * Invasive ER-positive cancer on biopsy and subsequent definitive surgical therapy * Received and Completed standard of care adjuvant therapy (Concurrent endocrine therapy acceptable) * 6-12 months after completion of therapy (excluding adjuvant endocrine therapy) at time of randomization
Exclusion criteria
* Recurrent breast cancer * DCIS only (no invasive component) * Taking a Beta Blocker or Verapamil * Pregnant * Wheelchair bound * Unable to ambulate independently * Concurrent uncontrolled medical or psychiatric disorder * Open wound * Stage IV breast cancer * Progression of disease * Bilateral mastectomies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants that complete the study as a measure of feasibility of an exercise intervention in obese breast cancer survivors. | 12 months | Number of participants that enroll in the study and actually complete the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IGF-1, endostatin, and VEGF levels in obese breast cancer survivors undergoing an exercise intervention as a measure of angiostatic phenotype: | 12 months | 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 | 12 months | Adipose tissue mass volume as measured on CT scan |
Countries
United States
Outcome results
None listed