Pilot Study of the Effect of a Low Glycemic Index Diet on Breast Density (Diet and Breast Health Study )

Roswell Park Cancer Institute1 site in 1 country46 target enrollmentMarch 2006

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Roswell Park Cancer Institute
Enrollment: 46
Locations: 1
Primary Endpoint: Diet Change
Status: Terminated
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 2006

End Date

October 2008

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Roswell Park Cancer Institute

Responsible Party

Sponsor

Eligibility 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)

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Diet Change

Time Frame: 2 years

To Assess the feasibility of a randomized trial to achieve diet change and promote longterm adoption of a low glycemic index diet intervention among women at high risk for breast cancer (\> 50% of breast area occupied by radiological density)