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Clinical Trials/NCT01582685
NCT01582685
Withdrawn
Not Applicable

Exercise in Breast Cancer Survivors: Analysis of Angiogenic Profile

University of Mississippi Medical Center1 site in 1 countryApril 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
University of Mississippi Medical Center
Locations
1
Primary Endpoint
Number of participants that complete the study as a measure of feasibility of an exercise intervention in obese breast cancer survivors.
Status
Withdrawn
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2012
End Date
June 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Natale Sheehan

Assistant Professor of Medicine

University of Mississippi Medical Center

Eligibility Criteria

Inclusion Criteria

  • \> 18 years of age and \< 65 years of age
  • 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
  • Wheelchair bound
  • Unable to ambulate independently
  • Concurrent uncontrolled medical or psychiatric disorder
  • Open wound
  • Stage IV breast cancer
  • Progression of disease
  • Bilateral mastectomies

Outcomes

Primary Outcomes

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

Number of participants that enroll in the study and actually complete the study

Secondary Outcomes

  • 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)
  • IGF-1, endostatin, and VEGF levels in obese breast cancer survivors undergoing an exercise intervention as a measure of angiostatic phenotype:(12 months)

Study Sites (1)

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