Status:
COMPLETED
Effects of Physical Activity and Dietary Change in Minority Breast Cancer Survivors
Lead Sponsor:
Columbia University
Conditions:
Breast Cancer
Eligibility:
FEMALE
21-70 years
Phase:
PHASE2
Brief Summary
This study is testing the effects of exercise and dietary change on weight reduction and biological markers associated with breast cancer risk in breast cancer survivors of Hispanic or African descent...
Eligibility Criteria
Inclusion
- 21-70 yrs
- Stage 0-IIIa breast cancer
- No evidence of recurrent/metastatic disease
- Hispanic or African descent (African-American or Caribbean)
- BMI \> 25kg/m2
- Sedentary
- Completed surgery, chemotherapy, and radiation therapy ≥ 6 months
- Blood pressure \< 140/90
- HgbA1C \< 8
- LDL cholesterol \< 150
- No uncontrolled comorbidities
- VO2 max normal EKG changes
- Non-smoker
Exclusion
- Evidence of recurrent or metastatic breast cancer
- Uncontrolled co-morbid illness including, but not limited to, type I diabetes mellitus, type II diabetes mellitus, hypertension, symptomatic congestive heart failure, unstable angina pectoris, claudication, cardiac arrhythmia; active pulmonary disease; hypercholesterolemia, neurological condition, ischemic heart disease, cardiac disease, kidney disease, respiration problems, asthma, shortness of breath, physical limitations, abnormal thyroid function, active malignancy, except for squamous or basal cell carcinoma of the skin; receiving active chemotherapy or radiotherapy; or psychiatric illness/social situations that would limit compliance with study requirements
- Currently taking Herceptin therapy, or abnormal echo or MUGA post-Herceptin therapy
- Active tobacco use
- Currently active in an exercise and/or dietary change weight loss program
- If a participant develops a breast cancer recurrence or metastasis during the 12-month study period, her participation in the study will be terminated.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT00811824
Start Date
July 1 2007
End Date
November 1 2012
Last Update
February 22 2013
Active Locations (1)
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1
Columbia University
New York, New York, United States, 10032