Exercise in Breast Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01582685
Recruitment Status : Withdrawn (no patients enrolled)
First Posted : April 23, 2012
Last Update Posted : December 2, 2014
Information provided by (Responsible Party):
Natale Sheehan, University of Mississippi Medical Center

April 2, 2012
April 23, 2012
December 2, 2014
April 2012
June 2014   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01582685 on Archive Site
  • 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 ]
    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 ]
    Adipose tissue mass volume as measured on CT scan
Same as current
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Exercise in Breast Cancer Survivors
Exercise in Breast Cancer Survivors: Analysis of Angiogenic Profile
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.
Not Provided
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
  • Breast Cancer
  • Obesity
Behavioral: Exercise
The participant will exercise for 16 weeks under supervision. The exercise regimen is increased slowly over 16 weeks.
  • 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.
    Intervention: Behavioral: Exercise
  • No Intervention: No Exercise
    These participants will receive standard of care follow up.
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2014
June 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
Not Provided
Not Provided
Natale Sheehan, University of Mississippi Medical Center
University of Mississippi Medical Center
Not Provided
Principal Investigator: Natale Sheehan, MD University of Mississippi Health Care
University of Mississippi Medical Center
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP