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Diet and Breast Cancer Prevention Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00148057
First Posted: September 7, 2005
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Ontario Ministry of Health and Long Term Care
Canadian Breast Cancer Research Alliance
Information provided by:
University Health Network, Toronto
  Purpose
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 tissue on a mammogram have been recruited and allocated by a random (ie chance) process, to an intervention or control group. The intervention group has been taught how to reduce their fat intake to a target of 15% of total calories, while the control group continued their usual consumption of fat. Both groups have then been followed for at least 7 years and the number who develop breast cancer in each group will be compared

Condition Intervention Phase
Breast Cancer Behavioral: Low-fat diet Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: An Explanatory Clinical Trial of Breast Cancer Prevention

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • Breast cancer

Secondary Outcome Measures:
  • Other cancers
  • Benign breast disease

Estimated Enrollment: 4695
Study Start Date: January 1988
Estimated Study Completion Date: December 2005
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 the incidence of breast cancer by 37%. We propose to meet this goal by carrying out a randomized multi-centre trial of dietary intervention in subjects at increased risk of breast cancer that is now in progress.

The method used is to recruit subjects with extensive mammographic densities and enrol them in a randomized trial in which they receive one of two kinds of dietary counselling. A control group receives general advice about nutrition but is not counselled to change their intake of dietary fat or carbohydrate, and an intervention group is given intensive counselling to reduce their intake of total fat to a target of 15% of calories and increase intake of carbohydrate to maintain intake of total calories.

Recruitment to this trial has been in progress in Toronto, Hamilton, London and Windsor since 1991, and in Vancouver since 1994, and all of the 4,615 subjects required for the trial were recruited by November 1998.

The trial is explanatory in that it seeks to determine if there is a biological effect of dietary fat reduction in terms of a reduction in breast cancer incidence. To meet this goal we will select as participants highly motivated subjects who are at increased risk of breast cancer, provide them with a high level of assistance in making a dietary alteration, follow them carefully to ensure the correct identification of subjects who develop breast cancer, and analyse the results both according to intention to treat and dietary compliance. This trial does not attempt to assess directly the possible effects of dietary counselling on the health of the general public.

II Specific Aims

  1. To recruit 4,615 Canadian women with extensive mammographic density and to enrol them in a randomized trial of dietary fat reduction and follow up until 2006.
  2. To compare in the control and intervention groups of this trial the incidence of breast cancers, as well as other histological changes in the breast tissue of patients undergoing surgical biopsy of the breast.
  3. To determine if a reduction in dietary fat intake will reduce either the proportion of the breast area occupied by radiological signs of density or the total quantity of density.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. A previous history of cancer (excluding non-melanomatous skin cancer).
  2. Pregnant (or planning to be) or breast feeding.
  3. On a medically prescribed diet for any reason.
  4. Habitually (ie. 4 or more times per week) eats more than one meal a day in a restaurant.
  5. Previous mammoplasty, either reduction or augmentation.
  6. Previous or present treatment for the reduction of blood lipids.
  7. 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00148057


Locations
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Ontario Ministry of Health and Long Term Care
Canadian Breast Cancer Research Alliance
Investigators
Principal Investigator: Norman F Boyd, MD, DSc University Health Network, Toronto
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00148057     History of Changes
Other Study ID Numbers: 01-0428-C
14177
First Submitted: September 2, 2005
First Posted: September 7, 2005
Last Update Posted: December 9, 2005
Last Verified: August 2005

Keywords provided by University Health Network, Toronto:
Diet
Dietary fat
Breast cancer
Prevention

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