Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Male Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer
Conditions
Brief 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.
Detailed description
PRIMARY OBJECTIVES: I. To determine if omega-3 dietary supplementation (omega-3 fatty acid) results in higher polyunsaturated fatty acids (PUFA) levels in surgical specimens of normal and malignant breast tissue in women who took omega 3 tablets in comparison to those who took placebo. II. To determine if omega-3 dietary supplementation results in higher PUFA levels in plasma and red blood cells in women who took omega 3 tablets in comparison to those who took placebo. III. To determine if omega-3 dietary supplementation affects the metabolites of omega-3 and omega-6 PUFA in surgical specimens of malignant and normal breast tissue in comparison to controls. IV. To determine if women who take omega-3 dietary supplementation have less proliferation and greater apoptosis in malignant breast tissue in comparison to women who take placebo. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive omega-3 fatty acid orally (PO) daily for 7-14 days. ARM II: Patients receive placebo PO daily for 7-14 days.
Interventions
DRUGomega-3 fatty acid
Given PO
OTHERplacebo
Given PO
OTHERlaboratory biomarker analysis
Correlative studies
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PUFA Levels in Normal and Metastatic Breast Tissue | At time of surgery | Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3 |
| PUFA Levels in Plasma Pre and Post Surgery | Pre and post surgery | Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3 |
| PUFA Levels in Red Blood Cells Pre and Post Surgery | Pre and post surgery | Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | At time of surgery | ANOVA will be used to assess the effect in normal and malignant breast tissue. Metabolites tested: PGE2, PGD2, 20-HETE, 5-HEPE, 13-HODE, 9-HODE, 15-HETE, 12-HETE, 5-HETE. |
| Number of Days to Establish Difference in Proliferation in Malignant Breast Tissue | At time of surgery | ANOVA will be used to assess the effect of the supplementation in malignant breast tissue with less proliferation in malignant breast tissue in comparison to women who took the placebo. |
| Number of Days to Establish Increased Apoptosis in Malignant Breast Tissue | At time of surgery | ANOVA will be used to assess the effect of the supplementation in malignant breast tissue with greater apoptosis in malignant breast tissue in comparison to women who took the placebo. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Omega-3 Fatty Acid) Patients receive omega-3 fatty acid PO daily for 7-14 days.
omega-3 fatty acid: Given PO
laboratory biomarker analysis: Correlative studies | 28 |
| Arm II (Placebo) Patients receive placebo PO daily for 7-14 days.
placebo: Given PO
laboratory biomarker analysis: Correlative studies | 29 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 2 |
Baseline characteristics
| Characteristic | Arm I (Omega-3 Fatty Acid) | Total | Arm II (Placebo) |
|---|---|---|---|
| Age, Continuous | 57.8 Years STANDARD_DEVIATION 14 | 58.8 Years STANDARD_DEVIATION 12 | 59.9 Years STANDARD_DEVIATION 9.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 27 Participants | 55 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 23 Participants | 46 Participants | 23 Participants |
| Region of Enrollment United States | 28 participants | 57 participants | 29 participants |
| Sex: Female, Male Female | 28 Participants | 57 Participants | 29 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 28 | 0 / 29 |
| other Total, other adverse events | 2 / 28 | 1 / 27 |
| serious Total, serious adverse events | 0 / 28 | 0 / 27 |
Outcome results
Primary
PUFA Levels in Normal and Metastatic Breast Tissue
Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3
Time frame: At time of surgery
Population: All samples measurements were not available for all participants to be analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Differences in PUFA level 20:2 n-6 | -0.215 ug/ml | Standard Deviation 0.866 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Malignant breast 20:5 n-3 | 0.2 ug/ml | Standard Deviation 0.665 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Normal breast tissue 18:2 n-6 | 60.986 ug/ml | Standard Deviation 40.392 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Normal breast tissue 18:3 n-3 | 3.232 ug/ml | Standard Deviation 2.289 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Normal breast tissue 20:2 n-6 | 1.104 ug/ml | Standard Deviation 0.96 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Normal breast tissue 20:4 n-6 | 2.221 ug/ml | Standard Deviation 1.349 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Normal breast tissue 20:3 n-3 | 0.049 ug/ml | Standard Deviation 0.107 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Normal breast tissue 20:5 n-3 | 0.027 ug/ml | Standard Deviation 0.128 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Normal breast tissue 22:6 n-3 | 0.095 ug/ml | Standard Deviation 0.443 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Normal breast tissue n-3 | 3.402 ug/ml | Standard Deviation 2.572 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Normal breast tissue n-6 | 3.421 ug/ml | Standard Deviation 2.085 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Normal breast tissue n3/n-6 ratio | 0.948 ug/ml | Standard Deviation 0.468 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Malignant breast tissue 18:2 n-6 | 44.137 ug/ml | Standard Deviation 44.544 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Malignant breast 18:3 n-3 | 1.943 ug/ml | Standard Deviation 2.162 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Malignant breast 20:2 n-6 | 0.889 ug/ml | Standard Deviation 0.886 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Malignant breast 20:4 n-6 | 3.208 ug/ml | Standard Deviation 1.948 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Malignant breast 20:3 n-3 | 0.034 ug/ml | Standard Deviation 0.087 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Malignant breast 22:6 n-3 | 0 ug/ml | Standard Deviation 0 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Malignant breast n-3 | 2.178 ug/ml | Standard Deviation 2.41 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Malignant breast n-6 | 48.233 ug/ml | Standard Deviation 46.105 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Malignant breast n-3/n-6 ratio | 0.029 ug/ml | Standard Deviation 0.031 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Differences in PUFA level 18:2 n-6 | -16.85 ug/ml | Standard Deviation 51.043 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Differences in PUFA level 18:3 n-3 | -1.289 ug/ml | Standard Deviation 2.784 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Differences in PUFA level 20:4 n-6 | 0.986 ug/ml | Standard Deviation 1.595 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Differences in PUFA level 20:3 n-3 | -0.015 ug/ml | Standard Deviation 0.105 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Differences in PUFA level 20:5 n-3 | 0.173 ug/ml | Standard Deviation 0.545 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Differences in PUFA level 22:6 n-3 | -0.095 ug/ml | Standard Deviation 0.443 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Difference in PUFA level n-3 | -1.224 ug/ml | Standard Deviation 2.794 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Difference in PUFA level in n-6 | 44.812 ug/ml | Standard Deviation 45.463 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Normal and Metastatic Breast Tissue | Difference in n-3/n-6 ratio | -0.92 ug/ml | Standard Deviation 0.45 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Differences in PUFA level 20:2 n-6 | -0.407 ug/ml | Standard Deviation 0.514 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Malignant breast 20:3 n-3 | 0 ug/ml | Standard Deviation 0 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Malignant breast 20:5 n-3 | 0 ug/ml | Standard Deviation 0 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Normal breast tissue 18:2 n-6 | 72.762 ug/ml | Standard Deviation 50.742 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Differences in PUFA level 22:6 n-3 | -0.061 ug/ml | Standard Deviation 0.264 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Normal breast tissue 18:3 n-3 | 3.505 ug/ml | Standard Deviation 2.041 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Malignant breast 22:6 n-3 | 0 ug/ml | Standard Deviation 0 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Normal breast tissue 20:2 n-6 | 1.008 ug/ml | Standard Deviation 0.724 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Difference in PUFA level in n-6 | 33.173 ug/ml | Standard Deviation 31.836 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Normal breast tissue 20:4 n-6 | 2.342 ug/ml | Standard Deviation 1.445 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Malignant breast n-3 | 1.357 ug/ml | Standard Deviation 1.466 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Normal breast tissue 20:3 n-3 | 0.038 ug/ml | Standard Deviation 0.085 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Differences in PUFA level 20:3 n-3 | -0.038 ug/ml | Standard Deviation 0.085 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Normal breast tissue 20:5 n-3 | 0.034 ug/ml | Standard Deviation 0.147 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Malignant breast n-6 | 36.586 ug/ml | Standard Deviation 32.856 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Normal breast tissue 22:6 n-3 | 0.061 ug/ml | Standard Deviation 0.264 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Difference in PUFA level n-3 | -2.282 ug/ml | Standard Deviation 2.127 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Normal breast tissue n-3 | 3.64 ug/ml | Standard Deviation 2.24 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Malignant breast n-3/n-6 ratio | 0.032 ug/ml | Standard Deviation 0.016 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Normal breast tissue n-6 | 3.413 ug/ml | Standard Deviation 1.962 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Differences in PUFA level 20:5 n-3 | -0.034 ug/ml | Standard Deviation 0.147 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Normal breast tissue n3/n-6 ratio | 1.102 ug/ml | Standard Deviation 0.438 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Differences in PUFA level 18:2 n-6 | -39.027 ug/ml | Standard Deviation 38.697 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Malignant breast tissue 18:2 n-6 | 33.735 ug/ml | Standard Deviation 31.548 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Difference in n-3/n-6 ratio | -1.07 ug/ml | Standard Deviation 0.438 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Malignant breast 18:3 n-3 | 1.356 ug/ml | Standard Deviation 1.465 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Differences in PUFA level 18:3 n-3 | -2.149 ug/ml | Standard Deviation 1.935 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Malignant breast 20:2 n-6 | 0.601 ug/ml | Standard Deviation 0.657 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Differences in PUFA level 20:4 n-6 | -0.094 ug/ml | Standard Deviation 1.589 |
| Arm II (Placebo) | PUFA Levels in Normal and Metastatic Breast Tissue | Malignant breast 20:4 n-6 | 2.248 ug/ml | Standard Deviation 1.744 |
Primary
PUFA Levels in Plasma Pre and Post Surgery
Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3
Time frame: Pre and post surgery
Population: All samples measurements were not available for all participants to be analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Difference in n-3/n-6 ratio | 0.039 ug/ml | Standard Deviation 0.056 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Plasma pre-surgery 18:2 n-6 | 1514890 ug/ml | Standard Deviation 370945 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Plasma pre-surgery 18:3 n-3 | 37501 ug/ml | Standard Deviation 25256 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Plasma pre-surgery 20:2 n-6 | 7039 ug/ml | Standard Deviation 6213 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Plasma pre-surgery 20:4 n-6 | 210238 ug/ml | Standard Deviation 77734 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Plasma pre-surgery 20:3 n-3 | 0 ug/ml | Standard Deviation 0 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Plasma pre-surgery 20:5 n-3 | 38539 ug/ml | Standard Deviation 30967 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Plasma pre-surgery 22:6 n-3 | 132887 ug/ml | Standard Deviation 68619 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Plasma pre-surgery n-3 | 208297 ug/ml | Standard Deviation 105288 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Plasma pre-surgery n-6 | 1732167 ug/ml | Standard Deviation 373713 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Plasma pre-surgery n3/n-6 ratio | 0.121 ug/ml | Standard Deviation 0.058 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Plasma post-surgery 18:2 n-6 | 1504732 ug/ml | Standard Deviation 497732 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Plasma post-surgery 18:3 n-3 | 37472 ug/ml | Standard Deviation 18521 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Plasma post-surgery 20:2 n-6 | 5980 ug/ml | Standard Deviation 5351 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Plasma post-surgery 20:4 n-6 | 168100 ug/ml | Standard Deviation 63105 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Plasma post-surgery 20:3 n-3 | 0 ug/ml | Standard Deviation 0 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Plasma post-surgery 20:5 n-3 | 74521 ug/ml | Standard Deviation 48954 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Plasma post-surgery 22:6 n-3 | 153607 ug/ml | Standard Deviation 83888 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Plasma post-surgery n-3 | 265600 ug/ml | Standard Deviation 134862 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Plasma post-surgery n-6 | 1678812 ug/ml | Standard Deviation 538264 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Plasma post-surgery n-3/n-6 ratio | 0.16 ug/ml | Standard Deviation 0.067 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Differences in PUFA level 18:2 n-6 | -23266 ug/ml | Standard Deviation 602402 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Differences in PUFA level 18:3 n-3 | -554 ug/ml | Standard Deviation 36051 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Differences in PUFA level 20:2 n-6 | -824 ug/ml | Standard Deviation 7018 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Differences in PUFA level 20:4 n-6 | -37844 ug/ml | Standard Deviation 87910 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Differences in PUFA level 20:3 n-3 | 0 ug/ml | Standard Deviation 0 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Differences in PUFA level 20:5 n-3 | 35551 ug/ml | Standard Deviation 38628 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Differences in PUFA level 22:6 n-3 | 21487 ug/ml | Standard Deviation 68743 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Difference in PUFA level n-3 | 56484 ug/ml | Standard Deviation 119807 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Plasma Pre and Post Surgery | Difference in PUFA level in n-6 | -61935 ug/ml | Standard Deviation 653885 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Differences in PUFA level 18:3 n-3 | 1583 ug/ml | Standard Deviation 20838 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Plasma post-surgery 20:3 n-3 | 0 ug/ml | Standard Deviation 0 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Plasma pre-surgery 18:2 n-6 | 1539300 ug/ml | Standard Deviation 370726 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Difference in n-3/n-6 ratio | 0.015 ug/ml | Standard Deviation 0.041 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Plasma pre-surgery 18:3 n-3 | 33119 ug/ml | Standard Deviation 19368 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Plasma post-surgery 20:5 n-3 | 52643.85 ug/ml | Standard Deviation 32019.8 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Plasma pre-surgery 20:2 n-6 | 6031 ug/ml | Standard Deviation 5612 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Differences in PUFA level 20:2 n-6 | 485 ug/ml | Standard Deviation 5683 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Plasma pre-surgery 20:4 n-6 | 210006 ug/ml | Standard Deviation 83260 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Plasma post-surgery 22:6 n-3 | 133832.8 ug/ml | Standard Deviation 74361.31 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Plasma pre-surgery 20:3 n-3 | 0 ug/ml | Standard Deviation 0 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Differences in PUFA level 22:6 n-3 | 19001 ug/ml | Standard Deviation 72461 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Plasma pre-surgery 20:5 n-3 | 50206 ug/ml | Standard Deviation 41170 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Plasma post-surgery n-3 | 220679.4 ug/ml | Standard Deviation 108607.5 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Plasma pre-surgery 22:6 n-3 | 111798 ug/ml | Standard Deviation 79889 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Difference in PUFA level in n-6 | -42437 ug/ml | Standard Deviation 414325 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Plasma pre-surgery n-3 | 195123 ug/ml | Standard Deviation 106007 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Plasma post-surgery n-6 | 1718729 ug/ml | Standard Deviation 448393 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Plasma pre-surgery n-6 | 1755338 ug/ml | Standard Deviation 397402 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Differences in PUFA level 20:3 n-3 | 0 ug/ml | Standard Deviation 0 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Plasma pre-surgery n3/n-6 ratio | 0.11 ug/ml | Standard Deviation 0.049 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Plasma post-surgery n-3/n-6 ratio | 0.126 ug/ml | Standard Deviation 0.049 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Plasma post-surgery 18:2 n-6 | 1507750 ug/ml | Standard Deviation 419001.5 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Difference in PUFA level n-3 | 22874 ug/ml | Standard Deviation 83246 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Plasma post-surgery 18:3 n-3 | 34202.78 ug/ml | Standard Deviation 15615 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Differences in PUFA level 20:4 n-6 | -8045 ug/ml | Standard Deviation 69960 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Differences in PUFA level 18:2 n-6 | -34877 ug/ml | Standard Deviation 365683 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Plasma post-surgery 20:2 n-6 | 6851.409 ug/ml | Standard Deviation 5479.023 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Differences in PUFA level 20:5 n-3 | 2291 ug/ml | Standard Deviation 25409 |
| Arm II (Placebo) | PUFA Levels in Plasma Pre and Post Surgery | Plasma post-surgery 20:4 n-6 | 204127.2 ug/ml | Standard Deviation 85101.33 |
Primary
PUFA Levels in Red Blood Cells Pre and Post Surgery
Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3
Time frame: Pre and post surgery
Population: All samples measurements were not available for all participants to be analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells post-surgery 20:5 n-3 | 25301 ug/ml | Standard Deviation 29112 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells post-surgery 20:4 n-6 | 149267 ug/ml | Standard Deviation 70598 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells post-surgery 22:6 n-3 | 110198 ug/ml | Standard Deviation 90038 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells pre-surgery n-3 | 0 ug/ml | Standard Deviation 0 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells post-surgery n-3 | 0 ug/ml | Standard Deviation 0 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells pre-surgeryy 20:4 n-6 | 132624 ug/ml | Standard Deviation 68691 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells post-surgery n-6 | 0 ug/ml | Standard Deviation 0 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells pre-surgery n-6 | 0 ug/ml | Standard Deviation 0 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells post-surgery n-3/n-6 ratio | 0 ug/ml | Standard Deviation 0 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells pre-surgery 18:3 n-3 | 3430 ug/ml | Standard Deviation 4505 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Differences in PUFA level 18:2 n-6 | 35856 ug/ml | Standard Deviation 213680 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells pre-surgery n3/n-6 ratio | 0 ug/ml | Standard Deviation 0 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Differences in PUFA level 18:3 n-3 | 1709 ug/ml | Standard Deviation 4746 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells pre-surgery 20:3 n-3 | 0 ug/ml | Standard Deviation 0 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Differences in PUFA level 20:2 n-6 | 948 ug/ml | Standard Deviation 3481 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells post-surgery 18:2 n-6 | 391882 ug/ml | Standard Deviation 183779 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Differences in PUFA level 20:4 n-6 | 23282 ug/ml | Standard Deviation 94096 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells pre-surgery 18:2 n-6 | 351125 ug/ml | Standard Deviation 130630 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Differences in PUFA level 20:3 n-3 | 0 ug/ml | Standard Deviation 0 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells post-surgery 18:3 n-3 | 5320 ug/ml | Standard Deviation 4709 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Differences in PUFA level 20:5 n-3 | 15066 ug/ml | Standard Deviation 29266 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells pre-surgery 20:5 n-3 | 9723 ug/ml | Standard Deviation 13112 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Differences in PUFA level 22:6 n-3 | 42086 ug/ml | Standard Deviation 101629 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells post-surgery 20:2 n-6 | 3922 ug/ml | Standard Deviation 3941 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Difference in PUFA level n-3 | 0 ug/ml | Standard Deviation 0 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells pre-surgery 20:2 n-6 | 2826 ug/ml | Standard Deviation 3515 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Difference in PUFA level in n-6 | 0 ug/ml | Standard Deviation 0 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells post-surgery 20:3 n-3 | 0 ug/ml | Standard Deviation 0 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Difference in n-3/n-6 ratio | 0 ug/ml | Standard Deviation 0 |
| Arm I (Omega-3 Fatty Acid) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells pre-surgery 22:6 n-3 | 79934 ug/ml | Standard Deviation 77518 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Difference in n-3/n-6 ratio | 0 ug/ml | Standard Deviation 0 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells pre-surgery 18:2 n-6 | 387455 ug/ml | Standard Deviation 119089 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells pre-surgery 18:3 n-3 | 3211 ug/ml | Standard Deviation 4026 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells pre-surgery 20:2 n-6 | 4014 ug/ml | Standard Deviation 4183 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells pre-surgeryy 20:4 n-6 | 144208 ug/ml | Standard Deviation 71426 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells pre-surgery 20:3 n-3 | 0 ug/ml | Standard Deviation 0 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells pre-surgery 20:5 n-3 | 11005 ug/ml | Standard Deviation 14840 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells pre-surgery 22:6 n-3 | 90668 ug/ml | Standard Deviation 74168 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells pre-surgery n-3 | 0 ug/ml | Standard Deviation 0 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells pre-surgery n-6 | 0 ug/ml | Standard Deviation 0 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells pre-surgery n3/n-6 ratio | 0 ug/ml | Standard Deviation 0 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells post-surgery 18:2 n-6 | 373679 ug/ml | Standard Deviation 103361 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells post-surgery 18:3 n-3 | 2103 ug/ml | Standard Deviation 5007 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells post-surgery 20:4 n-6 | 116868 ug/ml | Standard Deviation 73523 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells post-surgery 20:3 n-3 | 0 ug/ml | Standard Deviation 0 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells post-surgery 20:5 n-3 | 9818 ug/ml | Standard Deviation 20929 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells post-surgery 22:6 n-3 | 64117 ug/ml | Standard Deviation 96118 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells post-surgery n-3 | 0 ug/ml | Standard Deviation 0 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells post-surgery n-6 | 0 ug/ml | Standard Deviation 0 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells post-surgery n-3/n-6 ratio | 0 ug/ml | Standard Deviation 0 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Differences in PUFA level 18:2 n-6 | -13776 ug/ml | Standard Deviation 134998 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Differences in PUFA level 18:3 n-3 | -1109 ug/ml | Standard Deviation 5750 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Differences in PUFA level 20:2 n-6 | -2172 ug/ml | Standard Deviation 5204 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Differences in PUFA level 20:4 n-6 | -27340 ug/ml | Standard Deviation 117792 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Differences in PUFA level 20:3 n-3 | 0 ug/ml | Standard Deviation 0 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Differences in PUFA level 20:5 n-3 | -1187 ug/ml | Standard Deviation 28583 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Differences in PUFA level 22:6 n-3 | -26551 ug/ml | Standard Deviation 128776 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Difference in PUFA level n-3 | 0 ug/ml | Standard Deviation 0 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Difference in PUFA level in n-6 | 0 ug/ml | Standard Deviation 0 |
| Arm II (Placebo) | PUFA Levels in Red Blood Cells Pre and Post Surgery | Red blood cells post-surgery 20:2 n-6 | 1842 ug/ml | Standard Deviation 3315 |
Secondary
Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue
ANOVA will be used to assess the effect in normal and malignant breast tissue. Metabolites tested: PGE2, PGD2, 20-HETE, 5-HEPE, 13-HODE, 9-HODE, 15-HETE, 12-HETE, 5-HETE.
Time frame: At time of surgery
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Normal breast tissue 12HETE | 12.05 ug/ml | Standard Deviation 11.37 |
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Normal breast tissue PGD2 | 4.47 ug/ml | Standard Deviation 16.17 |
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Normal breast tissue 20HETE | 1.43 ug/ml | Standard Deviation 6.87 |
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Normal breast tissue 13HODE | 4881.23 ug/ml | Standard Deviation 11979.79 |
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Normal breast tissue 9HODE | 729.38 ug/ml | Standard Deviation 1789.68 |
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Normal breast tissue 15HETE | 13.99 ug/ml | Standard Deviation 28.41 |
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Normal breast tissue PGE2 | 9.14 ug/ml | Standard Deviation 24.59 |
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Normal breast tissue 5HETE | 4.75 ug/ml | Standard Deviation 4.47 |
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Malignant breast tissue PGE2 | 328.12 ug/ml | Standard Deviation 884.633 |
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Malignant breast tissue PGD2 | 335.88 ug/ml | Standard Deviation 894.77 |
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Malignant breast tissue 20HETE | 11.52 ug/ml | Standard Deviation 44.5 |
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Malignant breast tissue 13HODE | 4584.87 ug/ml | Standard Deviation 10465.02 |
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Malignant breast tissue 9HODE | 694.78 ug/ml | Standard Deviation 1611.17 |
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Malignant breast tissue 15HETE | 91.11 ug/ml | Standard Deviation 199.85 |
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Malignant breast tissue 12HETE | 79.17 ug/ml | Standard Deviation 233.57 |
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Malignant breast tissue 5HETE | 11.7 ug/ml | Standard Deviation 21.91 |
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Difference in PGE2 | 319 ug/ml | Standard Deviation 868.1 |
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Difference in PGD2 | 331.4 ug/ml | Standard Deviation 896.4 |
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Difference in 20HETE | 10.1 ug/ml | Standard Deviation 45.4 |
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Difference in 13HODE | -296.4 ug/ml | Standard Deviation 4812.1 |
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Difference in 9HODE | -34.6 ug/ml | Standard Deviation 761.9 |
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Difference in 15HETE | 77.1 ug/ml | Standard Deviation 191.4 |
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Difference in 12HETE | 67.1 ug/ml | Standard Deviation 229.4 |
| Arm I (Omega-3 Fatty Acid) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Difference in 5HETE | 7 ug/ml | Standard Deviation 19.6 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Difference in 12HETE | 6.7 ug/ml | Standard Deviation 15.5 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Normal breast tissue PGE2 | 1.12 ug/ml | Standard Deviation 4.5 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Malignant breast tissue 9HODE | 350.07 ug/ml | Standard Deviation 655.21 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Normal breast tissue PGD2 | 2.27 ug/ml | Standard Deviation 9.32 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Difference in 20HETE | 7.3 ug/ml | Standard Deviation 52.5 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Normal breast tissue 20HETE | 4.24 ug/ml | Standard Deviation 18.47 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Malignant breast tissue 15HETE | 95.85 ug/ml | Standard Deviation 190.12 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Normal breast tissue 13HODE | 2308.05 ug/ml | Standard Deviation 4654.22 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Difference in 15HETE | 67.7 ug/ml | Standard Deviation 210.4 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Normal breast tissue 9HODE | 335.48 ug/ml | Standard Deviation 643.24 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Malignant breast tissue 12HETE | 14.52 ug/ml | Standard Deviation 15.02 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Normal breast tissue 15HETE | 28.12 ug/ml | Standard Deviation 79.73 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Difference in 13HODE | 35.4 ug/ml | Standard Deviation 4412.3 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Normal breast tissue 12HETE | 7.87 ug/ml | Standard Deviation 8.86 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Malignant breast tissue 5HETE | 5.74 ug/ml | Standard Deviation 7.74 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Normal breast tissue 5HETE | 84.07 ug/ml | Standard Deviation 354.6 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Difference in 5HETE | -78.3 ug/ml | Standard Deviation 355.4 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Malignant breast tissue PGE2 | 81.15 ug/ml | Standard Deviation 181.54 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Difference in PGE2 | 80 ug/ml | Standard Deviation 182.1 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Malignant breast tissue PGD2 | 92.01 ug/ml | Standard Deviation 184.18 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Difference in 9HODE | 14.6 ug/ml | Standard Deviation 673.4 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Malignant breast tissue 20HETE | 11.49 ug/ml | Standard Deviation 48.06 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Difference in PGD2 | 89.7 ug/ml | Standard Deviation 185.6 |
| Arm II (Placebo) | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | Malignant breast tissue 13HODE | 2343.46 ug/ml | Standard Deviation 4379.73 |
Secondary
Number of Days to Establish Difference in Proliferation in Malignant Breast Tissue
ANOVA will be used to assess the effect of the supplementation in malignant breast tissue with less proliferation in malignant breast tissue in comparison to women who took the placebo.
Time frame: At time of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Omega-3 Fatty Acid) | Number of Days to Establish Difference in Proliferation in Malignant Breast Tissue | 23.7 Days on treatment | Standard Deviation 16.6 |
| Arm II (Placebo) | Number of Days to Establish Difference in Proliferation in Malignant Breast Tissue | 24.2 Days on treatment | Standard Deviation 23.9 |
p-value: 0.93ANOVA
Secondary
Number of Days to Establish Increased Apoptosis in Malignant Breast Tissue
ANOVA will be used to assess the effect of the supplementation in malignant breast tissue with greater apoptosis in malignant breast tissue in comparison to women who took the placebo.
Time frame: At time of surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Arm I (Omega-3 Fatty Acid) | Number of Days to Establish Increased Apoptosis in Malignant Breast Tissue | 2.6 Days on treatment | Standard Deviation 2.2 |
| Arm II (Placebo) | Number of Days to Establish Increased Apoptosis in Malignant Breast Tissue | 3.2 Days on treatment | Standard Deviation 2.4 |
p-value: 0.29ANOVA