Exercise in Breast Cancer Survivors

This study is currently recruiting participants. (see Contacts and Locations)
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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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 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 ] [ Designated as safety issue: Yes ]
    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 ] [ 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


Estimated Enrollment: 10
Study Start Date: April 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582685

Contacts
Contact: Natale Sheehan, MD 601-984-5590 ntsheehan@umc.edu

Locations
United States, Mississippi
University of Mississippi Health Care Recruiting
Jackson, Mississippi, United States, 39216
Contact: Natale Sheehan, MD    601-984-5590    ntsheehan@umc.edu   
Principal Investigator: Natal Sheehan, MD         
Sponsors and Collaborators
University of Mississippi Medical Center
Investigators
Principal Investigator: Natale Sheehan, MD University of Mississippi Health Care
  More Information

No publications provided

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
Study First Received: April 2, 2012
Last Updated: April 22, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Breast Neoplasms
Obesity
Body Weight
Breast Diseases
Neoplasms
Neoplasms by Site
Nutrition Disorders
Overnutrition
Overweight
Signs and Symptoms
Skin Diseases

ClinicalTrials.gov processed this record on October 23, 2014