Exercise in Breast Cancer Survivors

December 1, 2014 updated by: Natale Sheehan, University of Mississippi Medical Center

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Health Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Mississippi Medical Center

Investigators

  • Principal Investigator: Natale Sheehan, MD, University of Mississippi Health Care

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

April 2, 2012

First Submitted That Met QC Criteria

April 19, 2012

First Posted (Estimate)

April 23, 2012

Study Record Updates

Last Update Posted (Estimate)

December 2, 2014

Last Update Submitted That Met QC Criteria

December 1, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-0121

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity

Clinical Trials on Exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe