Clinical trial · Interventional
Diet and Breast Cancer Prevention Trial
An Explanatory Clinical Trial of Breast Cancer Prevention
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low-fat diet | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Breast cancer
Secondary outcomes (2)
- measure
- Other cancers
- measure
- Benign breast disease
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDHidaka 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 28361752
- DERIVEDMartin 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 27193584
- DERIVEDMartin 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 21199800