Breast CancerPhase 3NCT00148057
Diet and Breast Cancer Prevention Trial
A Phase 3 study testing Low-fat diet in people with Breast Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Low-fat diet
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 4,695 participants
- Where
- 1 siteCanada
- Study dates
- Jan 1988to Dec 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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. -
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Explanatory Clinical Trial of Breast Cancer Prevention
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
Read the 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
- 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.
- 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.
- 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.
- Conditions
- Breast Cancer
- Being tested
- Low-fat diet
- Keywords
- Diet, Dietary fat, Breast cancer, Prevention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-fat dietBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast cancer
Secondary outcomes (2)
Other cancers
Benign breast disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startJan 1988
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4,695 participants
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care, Canadian Breast Cancer Research Alliance
- Investigators
- Norman F Boyd, MD, DSc, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00148057
- Sponsor's protocol ID
- 01-0428-C
- Other IDs
- 14177
- Status last verified
- Aug 2005
- First submitted
- 2 Sep 2005
- Last updated
- 7 Sep 2005
- Results posted
- No
Publications
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.
PubMed 28361752Martin 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.
PubMed 27193584Martin 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.
PubMed 21199800
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Explanatory Clinical Trial of Breast Cancer Prevention
- ClinicalTrials.gov ID
- NCT00148057
- Acronym / sponsor ID
- 01-0428-C
- Conditions
- Breast Cancer
- Keywords
- Diet, Dietary fat, Breast cancer, Prevention
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,695 participants
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care, Canadian Breast Cancer Research Alliance
- Study start
- Jan 1988
- Study completion
- Dec 2005
- First posted
- 7 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 30 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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. -
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low-fat diet | Behavioural | – |
Primary outcome
Breast cancer
2 secondary outcomes
Other cancers
Benign breast disease
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2005.
- Derived from this study: PubMed 28361752Hidaka 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.
- Derived from this study: PubMed 27193584Martin 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.
- Derived from this study: PubMed 21199800Martin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norman F Boyd, MD, DSc principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Low-fat diet in people with Breast Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast cancer. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00148057, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2005.