Exercise in Breast Cancer Survivors

Study Overview
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Brief Summary
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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.

Official Title
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Exercise in Breast Cancer Survivors: Analysis of Angiogenic Profile

Conditions
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Breast Cancer, Obesity

Intervention / Treatment
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* Behavioral: Exercise


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Group<br>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. | Behavioral: Exercise<br>* The participant will exercise for 16 weeks under supervision. The exercise regimen is increased slowly over 16 weeks.<br>|
| No Intervention: No Exercise<br>These participants will receive standard of care follow up. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that complete the study as a measure of feasibility of an exercise intervention in obese breast cancer survivors. | Number of participants that enroll in the study and actually complete the study | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IGF-1, endostatin, and VEGF levels in obese breast cancer survivors undergoing an exercise intervention as a measure of angiostatic phenotype: | IFG-1 levels,unbound VEGF levels, Endostatin levels | 12 months | 
| 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 | Adipose tissue mass volume as measured on CT scan | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Obesity, Exercise, Angiogenesis