NCT00148057

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 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
4,695

participants targeted

Target at P75+ for phase_3 breast-cancer

Timeline
Completed

Started Jan 1988

Longer than P75 for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 1988

Completed
17.7 years until next milestone

First Submitted

Initial submission to the registry

September 2, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2005

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

September 7, 2005

Status Verified

August 1, 2005

First QC Date

September 2, 2005

Last Update Submit

September 2, 2005

Conditions

Breast Cancer

Keywords

DietDietary fatBreast cancerPrevention

Outcome Measures

Primary Outcomes (1)

  • Breast cancer

Secondary Outcomes (2)

  • Other cancers

  • Benign breast disease

Interventions

Low-fat dietBEHAVIORAL

Eligibility Criteria

Age30 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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. -

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (3)

  • Hidaka BH, Kimler BF, Fabian CJ, Carlson SE. An empirically derived dietary pattern associated with breast cancer risk is validated in a nested case-control cohort from a randomized primary prevention trial. Clin Nutr ESPEN. 2017 Feb;17:8-17. doi: 10.1016/j.clnesp.2016.10.008. Epub 2016 Nov 23.

    PMID: 28361752DERIVED

  • Martin LJ, Huszti E, Connelly PW, Greenberg CV, Minkin S, Boyd NF. RE: Serum Lipids, Lipoproteins, and Risk of Breast Cancer: A Nested Case-Control Study Using Multiple Time Points. J Natl Cancer Inst. 2016 May 18;108(8):djw126. doi: 10.1093/jnci/djw126. Print 2016 Aug. No abstract available.

    PMID: 27193584DERIVED

  • Martin LJ, Li Q, Melnichouk O, Greenberg C, Minkin S, Hislop G, Boyd NF. A randomized trial of dietary intervention for breast cancer prevention. Cancer Res. 2011 Jan 1;71(1):123-33. doi: 10.1158/0008-5472.CAN-10-1436.

    PMID: 21199800DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diet, Fat-Restricted

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Norman F Boyd, MD, DSc

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 2, 2005

First Posted

September 7, 2005

Study Start

January 1, 1988

Study Completion

December 1, 2005

Last Updated

September 7, 2005

Record last verified: 2005-08

Locations

CA(1)