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Exercise in Breast Cancer Survivors

This study has been withdrawn prior to enrollment.
(no patients enrolled)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01582685
First Posted: April 23, 2012
Last Update Posted: December 2, 2014
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.
Information provided by (Responsible Party):
Natale Sheehan, University of Mississippi Medical Center
  Purpose
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.

Condition Intervention
Breast Cancer Obesity Behavioral: Exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Exercise in Breast Cancer Survivors: Analysis of Angiogenic Profile

Resource links provided by NLM:


Further study details as provided by Natale Sheehan, University of Mississippi Medical Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Enrollment: 0
Study Start Date: April 2012
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Behavioral: Exercise
The participant will exercise for 16 weeks under supervision. The exercise regimen is increased slowly over 16 weeks.
No Intervention: No Exercise
These participants will receive standard of care follow up.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01582685


Locations
United States, Mississippi
University of Mississippi Health Care
Jackson, Mississippi, United States, 39216
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
Principal Investigator: Natale Sheehan, MD University of Mississippi Health Care
  More Information

Responsible Party: Natale Sheehan, Assistant Professor of Medicine, University of Mississippi Medical Center
ClinicalTrials.gov Identifier: NCT01582685     History of Changes
Other Study ID Numbers: 2011-0121
First Submitted: April 2, 2012
First Posted: April 23, 2012
Last Update Posted: December 2, 2014
Last Verified: December 2014

Keywords provided by Natale Sheehan, University of Mississippi Medical Center:
Breast Cancer
Obesity
Exercise
Angiogenesis

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases