Status:
TERMINATED
Effect of a Low Glycemic Index Diet on Breast Density
Lead Sponsor:
Roswell Park Cancer Institute
Conditions:
Breast Cancer
Eligibility:
FEMALE
40-60 years
Phase:
NA
Brief Summary
This study is a Pilot Phase II cancer intervention trial of a low glycemic index diet to reduce mammographic density in women at high risk for breast cancer.
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Are between 40 and 60 years of age
- Still menstruating with at least 10 menstrual cycles in the previous 12 months
- Not Taking hormone replacement therapy
- Stable oral contraceptive use (no changes is use in past 12 months nor changes intended during interventional period)
- Have not been previously diagnosed with breast cancer, DCIS,lobular carcinoma in situ, atypical lobular hyperplasia or atypical hyperplasia
- No history of breast augmentation or reduction surgery
- Have no history of any other malignancy (excluding non-melanoma skin cancer) in the previous 5 years
- Have no history of diabetes or other metabolic diseases requiring dietary modification
- Have a study baseline mammographic density of at least 50% as estimated by mammographer
- BIRADS 1 or 2 mammogram if first ever mammogram, otherwise stable mammogram (no change since previous year)
- Have not followed a weight reduction or Atkins typs diet in the past 6 months Not pregnant or lactating in the past 12 months, nor intending pregnancy during the study period
- Successful completion of three baseline telephone-administered 24- hour dietary recalls
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT01237938
Start Date
March 1 2006
Last Update
April 3 2014
Active Locations (1)
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1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263