Clinical trial · Interventional
Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer
A Randomized, Placebo-Controlled Phase II Clinical Trial of Omega-3 PUFA Dietary Supplementation in Patients With Stage I-III Breast Carcinoma
NCT01869764CI-TRIAL-00041359completedPhase 2Results postedClinicalTrials.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)
This phase II clinical trial studies how well omega-3 fatty acid works in treating patients with stage I-III breast cancer. Studying samples of tissue and blood in the laboratory from breast cancer patients receiving omega-3 fatty acid may help doctors learn more about the effects of omega-3 fatty acid on tumor cells.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ductal Breast Carcinoma in Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Lobular Breast Carcinoma in Situ | Breast Lobular Carcinoma In Situ | ALIAS | 0.90 |
| Male Breast Cancer | Male Breast Carcinoma | ALIAS | 0.90 |
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIC Breast Cancer |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| omega-3 fatty acid | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (omega-3 fatty acid)
- description
- Patients receive omega-3 fatty acid PO daily for 7-14 days.
- interventionNames
- Drug: omega-3 fatty acid
- Other: laboratory biomarker analysis
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Patients receive placebo PO daily for 7-14 days.
- interventionNames
- Other: placebo
- Other: laboratory biomarker analysis
Primary outcomes (3)
- measure
- PUFA Levels in Normal and Metastatic Breast Tissue
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed stage I to III breast cancer and carcinoma in situ (including lobular carcinoma in situ \[LCIS\] and ductal carcinoma in situ \[DCIS\]) * Breast surgery (lumpectomy or mastectomy) is planned for at least 7 days from the day of enrollment * Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved written informed consent document * Tumor measures at least 1 centimeter on imaging or physical exam Exclusion Criteria: * Any patient with surgery scheduled \< 7days after biopsy * Patients who are unable to refrain from the use of any NSAID or full-dose acetylsalicylic acid (ASA)-containing NSAID while taking study drug * Patients who will receive neoadjuvant chemotherapy are not eligible * Patients who are currently taking omega-3 fatty acids, as they are unable to be randomized to placebo * Patients who have previously taken omega-3 fatty acid within 1 month prior to study enrollment * Patients with an allergy or known hypersensitivity to fish
References
Publications (0)
Data not yet available
No reference posted for this study.