Exercise in Breast Cancer Survivors

Sponsor

University of Mississippi Medical Center (Other)

Overall Status

Withdrawn

CT.gov ID

NCT01582685

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Obesity	Behavioral: Exercise	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

Exercise in Breast Cancer Survivors: Analysis of Angiogenic Profile

Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Number of participants that complete the study as a measure of feasibility of an exercise intervention in obese breast cancer survivors. [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: [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 [12 months]
Adipose tissue mass volume as measured on CT scan

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Natale Sheehan, Assistant Professor of Medicine, University of Mississippi Medical Center

ClinicalTrials.gov Identifier:

NCT01582685

Other Study ID Numbers:

2011-0121

First Posted:

Apr 23, 2012

Last Update Posted:

Dec 2, 2014

Last Verified:

Dec 1, 2014

Keywords provided by Natale Sheehan, Assistant Professor of Medicine, University of Mississippi Medical Center

Additional relevant MeSH terms:

Breast Neoplasms

Study Results

No Results Posted as of Dec 2, 2014