Clinical trial · Interventional
Omega-3 Fatty Acids in Treating Women With Newly Diagnosed Ductal Carcinoma In Situ and/or Atypical Ductal Hyperplasia
Omega-3 Fatty Acids and Prevention of DCIS and/or ADH: A Translational Approach
NCT00627276CI-TRIAL-00027249completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
RATIONALE: Polyunsaturated fatty acids are important for normal growth and development. One type, called omega-3 fatty acids (found in fish, fish oil, and some other foods), may affect the growth of abnormal breast cells. PURPOSE: This randomized pilot trial is studying how well omega-3 fatty acids work in treating women with newly diagnosed ductal carcinoma in situ and/or atypical ductal hyperplasia.
Conditions
Conditions (2)
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 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| omega-3 fatty acid | Dietary Supplement | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I
- description
- Patients receive oral omega-3 fatty acid capsules 3 times daily for up to 8 weeks.
- interventionNames
- Dietary Supplement: omega-3 fatty acid
- type
- PLACEBO_COMPARATOR
- label
- Arm II
- description
- Patients receive oral placebo olive oil capsules 3 times daily for up to 8 weeks.
- interventionNames
- Other: placebo
Primary outcomes (1)
- measure
- Effect of omega-3 fatty acids on markers of breast cancer progression
- timeFrame
- minimum 2 weeks, maximum 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Biopsy confirmed diagnosis of any of the following: * Ductal carcinoma in situ (DCIS) and/or atypical ductal hyperplasia (ADH) * DCIS with a component of invasive carcinoma * ADH with a component of invasive carcinoma * DCIS and ADH with a component of invasive carcinoma * Newly diagnosed disease * No pure invasive breast cancer on biopsy without a component of DCIS or ADH * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Female * Menopausal status not specified * Not pregnant * Negative pregnancy test * Speaks English or Spanish * No allergy to fish oil or olive oil * No condition that, in the opinion of the study clinician, would make participation in the study harmful to the patient PRIOR CONCURRENT THERAPY: * No concurrent therapeutic anticoagulation * No concurrent use of fish oil \> 1 g/day
References
Publications (0)
Data not yet available
No reference posted for this study.