Status:

COMPLETED

Diet and Breast Cancer Prevention Trial

Lead Sponsor:

University Health Network, Toronto

Collaborating Sponsors:

Ontario Ministry of Health and Long Term Care

Canadian Breast Cancer Research Alliance

Conditions:

Breast Cancer

Eligibility:

FEMALE

30-65 years

Phase:

PHASE3

Brief Summary

This randomized controlled trial tests the hypothesis that a reduction in intake of dietary fat will reduce the incidence of breast cancer. Women with more than 50% of the breast occupied by dense tis...

Detailed Description

The long term goal of this trial is to determine if intervention in subjects with extensive mammographic densities (a risk factor for breast cancer) with a low fat-high carbohydrate diet will reduce t...

Eligibility Criteria

Inclusion

  • A mammogram with at least 50% of the breast area occupied by radiological signs of density.
  • Aged more than 30 years and less than 65 years.
  • Body Mass Index \>19 and \<27.
  • Resident within easy commuting distance of a participating centre. -

Exclusion

  • A previous history of cancer (excluding non-melanomatous skin cancer).
  • Pregnant (or planning to be) or breast feeding.
  • On a medically prescribed diet for any reason.
  • Habitually (ie. 4 or more times per week) eats more than one meal a day in a restaurant.
  • Previous mammoplasty, either reduction or augmentation.
  • Previous or present treatment for the reduction of blood lipids.
  • Proposed breast biopsy as a result of the initial clinical and/or mammographic examination, until such time as the biopsy has been carried out and is known to be benign

Key Trial Info

Start Date :

January 1 1988

Trial Type :

INTERVENTIONAL

End Date :

December 1 2005

Estimated Enrollment :

4695 Patients enrolled

Trial Details

Trial ID

NCT00148057

Start Date

January 1 1988

End Date

December 1 2005

Last Update

September 7 2005

Active Locations (1)

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1

University Health Network

Toronto, Ontario, Canada, M5G 2M9