Phase 2
N=57
Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer
Ductal Breast Carcinoma in Situ · Lobular Breast Carcinoma in Situ · Male Breast Cancer · Stage IA Breast Cancer · Stage IB Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01869764 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: PUFA Levels in Normal and Metastatic Breast Tissue — 60.986; 72.762; 3.232; 3.505 ug/ml
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- omega-3 fatty acid (Drug); placebo (Other); laboratory biomarker analysis (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Wake Forest University Health Sciences
- Primary completion
- Jul 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PUFA Levels in Normal and Metastatic Breast Tissue |
60.986; 72.762; 3.232; 3.505; 1.104; 1.008 | — |
| PRIMARY PUFA Levels in Plasma Pre and Post Surgery |
1514890; 1539300; 37501; 33119; 7039; 6031 | — |
| PRIMARY PUFA Levels in Red Blood Cells Pre and Post Surgery |
351125; 387455; 3430; 3211; 2826; 4014 | — |
| SECONDARY Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue |
9.14; 1.12; 4.47; 2.27; 1.43; 4.24 | — |
| SECONDARY Number of Days to Establish Difference in Proliferation in Malignant Breast Tissue |
23.7; 24.2 | 0.93 |
| SECONDARY Number of Days to Establish Increased Apoptosis in Malignant Breast Tissue |
2.6; 3.2 | 0.29 |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01869764). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.