Exercise in Breast Cancer Survivors
Primary Purpose
Breast Cancer, Obesity
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring Breast Cancer, Obesity, Exercise, Angiogenesis
Eligibility 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
Sites / Locations
- University of Mississippi Health Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise Group
No Exercise
Arm Description
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.
These participants will receive standard of care follow up.
Outcomes
Primary Outcome Measures
Number of participants that complete the study as a measure of feasibility of an exercise intervention in obese breast cancer survivors.
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:
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
Adipose tissue mass volume as measured on CT scan
Full Information
NCT ID
NCT01582685
First Posted
April 2, 2012
Last Updated
December 1, 2014
Sponsor
University of Mississippi Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01582685
Brief Title
Exercise in Breast Cancer Survivors
Official Title
Exercise in Breast Cancer Survivors: Analysis of Angiogenic Profile
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Withdrawn
Why Stopped
no patients enrolled
Study Start Date
April 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Mississippi Medical Center
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Obesity
Keywords
Breast Cancer, Obesity, Exercise, Angiogenesis
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
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.
Arm Title
No Exercise
Arm Type
No Intervention
Arm Description
These participants will receive standard of care follow up.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
The participant will exercise for 16 weeks under supervision. The exercise regimen is increased slowly over 16 weeks.
Primary Outcome Measure Information:
Title
Number of participants that complete the study as a measure of feasibility of an exercise intervention in obese breast cancer survivors.
Description
Number of participants that enroll in the study and actually complete the study
Time Frame
12 months
Secondary Outcome Measure Information:
Title
IGF-1, endostatin, and VEGF levels in obese breast cancer survivors undergoing an exercise intervention as a measure of angiostatic phenotype:
Description
IFG-1 levels,unbound VEGF levels, Endostatin levels
Time Frame
12 months
Title
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
Description
Adipose tissue mass volume as measured on CT scan
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natale Sheehan, MD
Organizational Affiliation
University of Mississippi Health Care
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Mississippi Health Care
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
12. IPD Sharing Statement
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Exercise in Breast Cancer Survivors
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