Exercise in Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Exercise in Breast Cancer Survivors: Analysis of Angiogenic Profile

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01582685
• Other study ID #: 2011-0121
• Status: Withdrawn
• Phase: N/A
• First received: April 2, 2012
• Last updated: December 1, 2014
• Start date: April 2012
• Est. completion date: June 2014

Study information

• Verified date: December 2014
• Source: University of Mississippi Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Obesity

Intervention

Behavioral:
• Exercise
The participant will exercise for 16 weeks under supervision. The exercise regimen is increased slowly over 16 weeks.

Locations

Country	Name	City	State
United States	University of Mississippi Health Care	Jackson	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
University of Mississippi Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months	Yes
Secondary	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	12 months	No
Secondary	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	12 months	No