Effect of a Low Glycemic Index Diet on Breast Density

Roswell Park Comprehensive Cancer Center

Status

Terminated

Conditions

Breast Cancer

Treatments

Behavioral: Low Glycemic Diet

Study type

Interventional

Funder types

Other

Identifiers

NCT01237938

I 71005

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

Female

Ages

40 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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