Exercise in Breast Cancer Survivors

This study is currently recruiting participants.
Verified April 2013 by University of Mississippi Medical Center
Sponsor:
Information provided by (Responsible Party):
Natale Sheehan, University of Mississippi Medical Center
ClinicalTrials.gov Identifier:
NCT01582685
First received: April 2, 2012
Last updated: April 22, 2013
Last verified: April 2013

April 2, 2012
April 22, 2013
April 2012
April 2013   (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 ] [ Designated as safety issue: Yes ]
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 ClinicalTrials.gov 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Adipose tissue mass volume as measured on CT scan
Same as current
Not Provided
Not Provided
 
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
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
April 2013
April 2013   (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
Female
18 Years and older
No
Contact: Natale Sheehan, MD 601-984-5590 ntsheehan@umc.edu
United States
 
NCT01582685
2011-0121
No
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
April 2013

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