Exercise in Breast Cancer Survivors

Not Applicable

Withdrawn

• Conditions: Breast Cancer; Obesity
• Interventions: Behavioral: Exercise

• Registration Number: NCT01582685
• Lead Sponsor: University of Mississippi Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-02
• Study First Submitted QC: 2012-04-19
• Study First Posted: 2012-04-23
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-01
• Last Update Posted: 2014-12-02

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Female
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise Group	Exercise	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

University of Mississippi Health Care; 🇺🇸 Jackson, Mississippi, United States