Clinical trial · Interventional
Dietary Energy Restriction and Omega-3 Fatty Acids on Mammary Tissue
Effect of Dietary Energy Restriction and Omega-3 Fatty Acids on Mammary Tissue and Systemic Biomarkers of Breast Cancer Risk
NCT01784042CI-TRIAL-00027447withdrawnEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No funding
Summary
Brief summary (as posted)
The over-reaching goal of this study is to test the merit of combining dietary energy restriction with omega-3 fatty acids as a safe and effective breast cancer chemoprevention strategy in overweight and obese women at high risk.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dietary energy restriction | Other | — | UNRESOLVED |
| Lovaza | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- PLACEBO_COMPARATOR
- label
- No dietary energy restriction plus Placebo
- description
- No dietary energy restriction plus Placebo
- interventionNames
- Drug: Placebo
- type
- PLACEBO_COMPARATOR
- label
- Dietary energy restriction plus placebo
- description
- Dietary energy restriction plus placebo
- interventionNames
- Drug: Placebo
- Other: Dietary energy restriction
- type
- EXPERIMENTAL
- label
- Lovaza
- description
- Lovaza only
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 30 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Five year predicted breast cancer risk of at least 1.66%. * Prior breast biopsy showing atypical ductal or lobular hyperplasia or lobular carcinoma in situ or ductal carcinoma in situ (DCIS). * Known breast cancer-1 and -2 mutations. * Breast density \>50% as assessed by the conventional two-dimensional method. Exclusion Criteria: * Weight loss of 10 pounds in past six months. * History of fish allergy. * Oral contraceptives or hormone replacement therapy in the past 6 months. * Pregnancy or lactation in the last 12 months or planning to become pregnant in the next 12 months. * Current smoking. * Diagnosis of cancer except basal cell carcinoma of the skin or lobular carcinoma in situ or DCIS. * Diagnosis of type 1 or type 2 diabetes based on standard criteria, irrespective of treatment. * Recent stroke or cardiovascular event. * History of eating disorders documented in medical records. * History of major gastrointestinal disease impairing absorption. * History of bariatric surgery. * Recent, current or planned use of diet drugs as per patient history. * Participants must not use flaxseed oil supplements during study participation. * Participants must not use Omega-3 preparations while participating on this trial. * Participants must not use Tamoxifen or Raloxifene during study participation.
References
Publications (0)
Data not yet available
No reference posted for this study.