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

History of Changes

Tracking Information

First Received Date ^ICMJE

April 2, 2012

Last Updated Date

April 22, 2013

Start Date ^ICMJE

April 2012

Estimated Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01582685 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Exercise in Breast Cancer Survivors

Official Title ^ICMJE

Exercise in Breast Cancer Survivors: Analysis of Angiogenic Profile

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention

Condition ^ICMJE

Breast Cancer
Obesity

Intervention ^ICMJE

Behavioral: Exercise

The participant will exercise for 16 weeks under supervision. The exercise regimen is increased slowly over 16 weeks.

Study Arm (s)

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.

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2013

Estimated Primary Completion Date

April 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Natale Sheehan, MD

601-984-5590

ntsheehan@umc.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01582685

Other Study ID Numbers ^ICMJE

2011-0121

Has Data Monitoring Committee

Responsible Party

Natale Sheehan, University of Mississippi Medical Center

Study Sponsor ^ICMJE

University of Mississippi Medical Center

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Natale Sheehan, MD

University of Mississippi Health Care

Information Provided By

University of Mississippi Medical Center

Verification Date

April 2013

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

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