NCT01237938

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 8, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2010

Completed
Last Updated

April 3, 2014

Status Verified

April 1, 2014

Enrollment Period

2.6 years

First QC Date

November 8, 2010

Last Update Submit

April 2, 2014

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Diet Change

    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)

    2 years

Secondary Outcomes (1)

  • Biomarkers

    4, 8 & 12 months on Treatment

Study Arms (1)

Low Glycemic Diet

EXPERIMENTAL
Behavioral: Low Glycemic Diet

Interventions

Low Glycemic DietBEHAVIORAL

Changing to low glycemic diet

Low Glycemic Diet

Eligibility Criteria

Age40 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Susan McCann, PhD

    Roswell Park Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2010

First Posted

November 10, 2010

Study Start

March 1, 2006

Primary Completion

October 1, 2008

Last Updated

April 3, 2014

Record last verified: 2014-04

Locations

US(1)