Effect of a Low Glycemic Index Diet on Breast Density

This study has been terminated.
(test)
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute
ClinicalTrials.gov Identifier:
NCT01237938
First received: November 8, 2010
Last updated: April 2, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: Low Glycemic Diet

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Pilot Study of the Effect of a Low Glycemic Index Diet on Breast Density (Diet and Breast Health Study )

Resource links provided by NLM:


Further study details as provided by Roswell Park Cancer Institute:

Primary Outcome Measures:
  • Diet Change [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • Biomarkers [ Time Frame: 4, 8 & 12 months on Treatment ] [ Designated as safety issue: No ]
    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.


Enrollment: 46
Study Start Date: March 2006
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Low Glycemic Diet Behavioral: Low Glycemic Diet
Changing to low glycemic diet

  Eligibility

Ages Eligible for Study:   40 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237938

Locations
United States, New York
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
Investigators
Principal Investigator: Susan McCann, PhD Roswell Park Cancer Institute
  More Information

No publications provided

Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01237938     History of Changes
Other Study ID Numbers: I 71005
Study First Received: November 8, 2010
Last Updated: April 2, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 30, 2014