Effect of a Low Glycemic Index Diet on Breast Density

Not Applicable

Terminated

• Conditions: Breast Cancer
• Interventions: Behavioral: Low Glycemic Diet

• Registration Number: NCT01237938
• Lead Sponsor: Roswell Park Cancer Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Primary Completion: 2008-10
• Study First Submitted: 2010-11-08
• Study First Submitted QC: 2010-11-09
• Study First Posted: 2010-11-10
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-02
• Last Update Posted: 2014-04-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 46

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Low Glycemic Diet	Low Glycemic Diet	-

Primary Outcome Measures

Name	Time	Method
Diet Change	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)

Secondary Outcome Measures

Name	Time	Method
Biomarkers	4, 8 & 12 months on Treatment	To estimate the effect of a low glycemic index diet on breast cancer related biomarkers, including those associated with carbohydrate, growth and steroid hormaone metabolism and mammograhic density. Result from this aim will provide important preliminary data for use in planning a larger clinical trial.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States