Trial Outcomes & Findings for Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer (NCT NCT01869764)
NCT ID: NCT01869764
Last Updated: 2019-10-30
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
At time of surgery
Results posted on
2019-10-30
Participant Flow
Participant milestones
| Measure |
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
|
Arm II (Placebo)
Patients receive placebo PO daily for 7-14 days.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
29
|
|
Overall Study
COMPLETED
|
28
|
27
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
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
|
Arm II (Placebo)
Patients receive placebo PO daily for 7-14 days.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm I (Omega-3 Fatty Acid)
n=28 Participants
Patients receive omega-3 fatty acid PO daily for 7-14 days.
omega-3 fatty acid: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=29 Participants
Patients receive placebo PO daily for 7-14 days.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.8 Years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
59.9 Years
STANDARD_DEVIATION 9.5 • n=7 Participants
|
58.8 Years
STANDARD_DEVIATION 12.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
28 participants
n=5 Participants
|
29 participants
n=7 Participants
|
57 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At time of surgeryPopulation: All samples measurements were not available for all participants to be analyzed.
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
Outcome measures
| Measure |
Arm I (Omega-3 Fatty Acid)
n=22 Participants
Patients receive omega-3 fatty acid PO daily for 7-14 days.
omega-3 fatty acid: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=19 Participants
Patients receive placebo PO daily for 7-14 days.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Normal breast tissue 18:2 n-6
|
60.986 ug/ml
Standard Deviation 40.392
|
72.762 ug/ml
Standard Deviation 50.742
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Normal breast tissue 18:3 n-3
|
3.232 ug/ml
Standard Deviation 2.289
|
3.505 ug/ml
Standard Deviation 2.041
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Normal breast tissue 20:2 n-6
|
1.104 ug/ml
Standard Deviation 0.96
|
1.008 ug/ml
Standard Deviation 0.724
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Normal breast tissue 20:4 n-6
|
2.221 ug/ml
Standard Deviation 1.349
|
2.342 ug/ml
Standard Deviation 1.445
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Normal breast tissue 20:3 n-3
|
0.049 ug/ml
Standard Deviation 0.107
|
0.038 ug/ml
Standard Deviation 0.085
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Normal breast tissue 20:5 n-3
|
0.027 ug/ml
Standard Deviation 0.128
|
0.034 ug/ml
Standard Deviation 0.147
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Normal breast tissue 22:6 n-3
|
0.095 ug/ml
Standard Deviation 0.443
|
0.061 ug/ml
Standard Deviation 0.264
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Normal breast tissue n-3
|
3.402 ug/ml
Standard Deviation 2.572
|
3.64 ug/ml
Standard Deviation 2.24
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Normal breast tissue n-6
|
3.421 ug/ml
Standard Deviation 2.085
|
3.413 ug/ml
Standard Deviation 1.962
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Normal breast tissue n3/n-6 ratio
|
0.948 ug/ml
Standard Deviation 0.468
|
1.102 ug/ml
Standard Deviation 0.438
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Malignant breast tissue 18:2 n-6
|
44.137 ug/ml
Standard Deviation 44.544
|
33.735 ug/ml
Standard Deviation 31.548
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Malignant breast 18:3 n-3
|
1.943 ug/ml
Standard Deviation 2.162
|
1.356 ug/ml
Standard Deviation 1.465
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Malignant breast 20:2 n-6
|
0.889 ug/ml
Standard Deviation 0.886
|
0.601 ug/ml
Standard Deviation 0.657
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Malignant breast 20:4 n-6
|
3.208 ug/ml
Standard Deviation 1.948
|
2.248 ug/ml
Standard Deviation 1.744
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Malignant breast 20:3 n-3
|
0.034 ug/ml
Standard Deviation 0.087
|
0 ug/ml
Standard Deviation 0
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Malignant breast 20:5 n-3
|
0.2 ug/ml
Standard Deviation 0.665
|
0 ug/ml
Standard Deviation 0
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Malignant breast 22:6 n-3
|
0 ug/ml
Standard Deviation 0
|
0 ug/ml
Standard Deviation 0
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Malignant breast n-3
|
2.178 ug/ml
Standard Deviation 2.41
|
1.357 ug/ml
Standard Deviation 1.466
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Malignant breast n-6
|
48.233 ug/ml
Standard Deviation 46.105
|
36.586 ug/ml
Standard Deviation 32.856
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Malignant breast n-3/n-6 ratio
|
0.029 ug/ml
Standard Deviation 0.031
|
0.032 ug/ml
Standard Deviation 0.016
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Differences in PUFA level 18:2 n-6
|
-16.85 ug/ml
Standard Deviation 51.043
|
-39.027 ug/ml
Standard Deviation 38.697
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Differences in PUFA level 18:3 n-3
|
-1.289 ug/ml
Standard Deviation 2.784
|
-2.149 ug/ml
Standard Deviation 1.935
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Differences in PUFA level 20:2 n-6
|
-0.215 ug/ml
Standard Deviation 0.866
|
-0.407 ug/ml
Standard Deviation 0.514
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Differences in PUFA level 20:4 n-6
|
0.986 ug/ml
Standard Deviation 1.595
|
-0.094 ug/ml
Standard Deviation 1.589
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Differences in PUFA level 20:3 n-3
|
-0.015 ug/ml
Standard Deviation 0.105
|
-0.038 ug/ml
Standard Deviation 0.085
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Differences in PUFA level 20:5 n-3
|
0.173 ug/ml
Standard Deviation 0.545
|
-0.034 ug/ml
Standard Deviation 0.147
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Differences in PUFA level 22:6 n-3
|
-0.095 ug/ml
Standard Deviation 0.443
|
-0.061 ug/ml
Standard Deviation 0.264
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Difference in PUFA level n-3
|
-1.224 ug/ml
Standard Deviation 2.794
|
-2.282 ug/ml
Standard Deviation 2.127
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Difference in PUFA level in n-6
|
44.812 ug/ml
Standard Deviation 45.463
|
33.173 ug/ml
Standard Deviation 31.836
|
|
PUFA Levels in Normal and Metastatic Breast Tissue
Difference in n-3/n-6 ratio
|
-0.92 ug/ml
Standard Deviation 0.45
|
-1.07 ug/ml
Standard Deviation 0.438
|
PRIMARY outcome
Timeframe: Pre and post surgeryPopulation: All samples measurements were not available for all participants to be analyzed.
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
Outcome measures
| Measure |
Arm I (Omega-3 Fatty Acid)
n=24 Participants
Patients receive omega-3 fatty acid PO daily for 7-14 days.
omega-3 fatty acid: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=19 Participants
Patients receive placebo PO daily for 7-14 days.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
PUFA Levels in Plasma Pre and Post Surgery
Plasma pre-surgery 18:2 n-6
|
1514890 ug/ml
Standard Deviation 370945
|
1539300 ug/ml
Standard Deviation 370726
|
|
PUFA Levels in Plasma Pre and Post Surgery
Plasma pre-surgery 18:3 n-3
|
37501 ug/ml
Standard Deviation 25256
|
33119 ug/ml
Standard Deviation 19368
|
|
PUFA Levels in Plasma Pre and Post Surgery
Plasma pre-surgery 20:2 n-6
|
7039 ug/ml
Standard Deviation 6213
|
6031 ug/ml
Standard Deviation 5612
|
|
PUFA Levels in Plasma Pre and Post Surgery
Plasma pre-surgery 20:4 n-6
|
210238 ug/ml
Standard Deviation 77734
|
210006 ug/ml
Standard Deviation 83260
|
|
PUFA Levels in Plasma Pre and Post Surgery
Plasma pre-surgery 20:3 n-3
|
0 ug/ml
Standard Deviation 0
|
0 ug/ml
Standard Deviation 0
|
|
PUFA Levels in Plasma Pre and Post Surgery
Plasma pre-surgery 20:5 n-3
|
38539 ug/ml
Standard Deviation 30967
|
50206 ug/ml
Standard Deviation 41170
|
|
PUFA Levels in Plasma Pre and Post Surgery
Plasma pre-surgery 22:6 n-3
|
132887 ug/ml
Standard Deviation 68619
|
111798 ug/ml
Standard Deviation 79889
|
|
PUFA Levels in Plasma Pre and Post Surgery
Plasma pre-surgery n-3
|
208297 ug/ml
Standard Deviation 105288
|
195123 ug/ml
Standard Deviation 106007
|
|
PUFA Levels in Plasma Pre and Post Surgery
Plasma pre-surgery n-6
|
1732167 ug/ml
Standard Deviation 373713
|
1755338 ug/ml
Standard Deviation 397402
|
|
PUFA Levels in Plasma Pre and Post Surgery
Plasma pre-surgery n3/n-6 ratio
|
0.121 ug/ml
Standard Deviation 0.058
|
0.11 ug/ml
Standard Deviation 0.049
|
|
PUFA Levels in Plasma Pre and Post Surgery
Plasma post-surgery 18:2 n-6
|
1504732 ug/ml
Standard Deviation 497732
|
1507750 ug/ml
Standard Deviation 419001.5
|
|
PUFA Levels in Plasma Pre and Post Surgery
Plasma post-surgery 18:3 n-3
|
37472 ug/ml
Standard Deviation 18521
|
34202.78 ug/ml
Standard Deviation 15615
|
|
PUFA Levels in Plasma Pre and Post Surgery
Plasma post-surgery 20:2 n-6
|
5980 ug/ml
Standard Deviation 5351
|
6851.409 ug/ml
Standard Deviation 5479.023
|
|
PUFA Levels in Plasma Pre and Post Surgery
Plasma post-surgery 20:4 n-6
|
168100 ug/ml
Standard Deviation 63105
|
204127.2 ug/ml
Standard Deviation 85101.33
|
|
PUFA Levels in Plasma Pre and Post Surgery
Plasma post-surgery 20:3 n-3
|
0 ug/ml
Standard Deviation 0
|
0 ug/ml
Standard Deviation 0
|
|
PUFA Levels in Plasma Pre and Post Surgery
Plasma post-surgery 20:5 n-3
|
74521 ug/ml
Standard Deviation 48954
|
52643.85 ug/ml
Standard Deviation 32019.8
|
|
PUFA Levels in Plasma Pre and Post Surgery
Plasma post-surgery 22:6 n-3
|
153607 ug/ml
Standard Deviation 83888
|
133832.8 ug/ml
Standard Deviation 74361.31
|
|
PUFA Levels in Plasma Pre and Post Surgery
Plasma post-surgery n-3
|
265600 ug/ml
Standard Deviation 134862
|
220679.4 ug/ml
Standard Deviation 108607.5
|
|
PUFA Levels in Plasma Pre and Post Surgery
Plasma post-surgery n-6
|
1678812 ug/ml
Standard Deviation 538264
|
1718729 ug/ml
Standard Deviation 448393
|
|
PUFA Levels in Plasma Pre and Post Surgery
Plasma post-surgery n-3/n-6 ratio
|
0.16 ug/ml
Standard Deviation 0.067
|
0.126 ug/ml
Standard Deviation 0.049
|
|
PUFA Levels in Plasma Pre and Post Surgery
Differences in PUFA level 18:2 n-6
|
-23266 ug/ml
Standard Deviation 602402
|
-34877 ug/ml
Standard Deviation 365683
|
|
PUFA Levels in Plasma Pre and Post Surgery
Differences in PUFA level 18:3 n-3
|
-554 ug/ml
Standard Deviation 36051
|
1583 ug/ml
Standard Deviation 20838
|
|
PUFA Levels in Plasma Pre and Post Surgery
Differences in PUFA level 20:2 n-6
|
-824 ug/ml
Standard Deviation 7018
|
485 ug/ml
Standard Deviation 5683
|
|
PUFA Levels in Plasma Pre and Post Surgery
Differences in PUFA level 20:4 n-6
|
-37844 ug/ml
Standard Deviation 87910
|
-8045 ug/ml
Standard Deviation 69960
|
|
PUFA Levels in Plasma Pre and Post Surgery
Differences in PUFA level 20:3 n-3
|
0 ug/ml
Standard Deviation 0
|
0 ug/ml
Standard Deviation 0
|
|
PUFA Levels in Plasma Pre and Post Surgery
Differences in PUFA level 20:5 n-3
|
35551 ug/ml
Standard Deviation 38628
|
2291 ug/ml
Standard Deviation 25409
|
|
PUFA Levels in Plasma Pre and Post Surgery
Differences in PUFA level 22:6 n-3
|
21487 ug/ml
Standard Deviation 68743
|
19001 ug/ml
Standard Deviation 72461
|
|
PUFA Levels in Plasma Pre and Post Surgery
Difference in PUFA level n-3
|
56484 ug/ml
Standard Deviation 119807
|
22874 ug/ml
Standard Deviation 83246
|
|
PUFA Levels in Plasma Pre and Post Surgery
Difference in PUFA level in n-6
|
-61935 ug/ml
Standard Deviation 653885
|
-42437 ug/ml
Standard Deviation 414325
|
|
PUFA Levels in Plasma Pre and Post Surgery
Difference in n-3/n-6 ratio
|
0.039 ug/ml
Standard Deviation 0.056
|
0.015 ug/ml
Standard Deviation 0.041
|
PRIMARY outcome
Timeframe: Pre and post surgeryPopulation: All samples measurements were not available for all participants to be analyzed.
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
Outcome measures
| Measure |
Arm I (Omega-3 Fatty Acid)
n=20 Participants
Patients receive omega-3 fatty acid PO daily for 7-14 days.
omega-3 fatty acid: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=18 Participants
Patients receive placebo PO daily for 7-14 days.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
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
|
373679 ug/ml
Standard Deviation 103361
|
|
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
|
2103 ug/ml
Standard Deviation 5007
|
|
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
|
387455 ug/ml
Standard Deviation 119089
|
|
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
|
3211 ug/ml
Standard Deviation 4026
|
|
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
|
4014 ug/ml
Standard Deviation 4183
|
|
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
|
144208 ug/ml
Standard Deviation 71426
|
|
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
|
0 ug/ml
Standard Deviation 0
|
|
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
|
11005 ug/ml
Standard Deviation 14840
|
|
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
|
90668 ug/ml
Standard Deviation 74168
|
|
PUFA Levels in Red Blood Cells Pre and Post Surgery
Red blood cells pre-surgery n-3
|
0 ug/ml
Standard Deviation 0
|
0 ug/ml
Standard Deviation 0
|
|
PUFA Levels in Red Blood Cells Pre and Post Surgery
Red blood cells pre-surgery n-6
|
0 ug/ml
Standard Deviation 0
|
0 ug/ml
Standard Deviation 0
|
|
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
|
0 ug/ml
Standard Deviation 0
|
|
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
|
1842 ug/ml
Standard Deviation 3315
|
|
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
|
116868 ug/ml
Standard Deviation 73523
|
|
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
|
0 ug/ml
Standard Deviation 0
|
|
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
|
9818 ug/ml
Standard Deviation 20929
|
|
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
|
64117 ug/ml
Standard Deviation 96118
|
|
PUFA Levels in Red Blood Cells Pre and Post Surgery
Red blood cells post-surgery n-3
|
0 ug/ml
Standard Deviation 0
|
0 ug/ml
Standard Deviation 0
|
|
PUFA Levels in Red Blood Cells Pre and Post Surgery
Red blood cells post-surgery n-6
|
0 ug/ml
Standard Deviation 0
|
0 ug/ml
Standard Deviation 0
|
|
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
|
0 ug/ml
Standard Deviation 0
|
|
PUFA Levels in Red Blood Cells Pre and Post Surgery
Differences in PUFA level 18:2 n-6
|
35856 ug/ml
Standard Deviation 213680
|
-13776 ug/ml
Standard Deviation 134998
|
|
PUFA Levels in Red Blood Cells Pre and Post Surgery
Differences in PUFA level 18:3 n-3
|
1709 ug/ml
Standard Deviation 4746
|
-1109 ug/ml
Standard Deviation 5750
|
|
PUFA Levels in Red Blood Cells Pre and Post Surgery
Differences in PUFA level 20:2 n-6
|
948 ug/ml
Standard Deviation 3481
|
-2172 ug/ml
Standard Deviation 5204
|
|
PUFA Levels in Red Blood Cells Pre and Post Surgery
Differences in PUFA level 20:4 n-6
|
23282 ug/ml
Standard Deviation 94096
|
-27340 ug/ml
Standard Deviation 117792
|
|
PUFA Levels in Red Blood Cells Pre and Post Surgery
Differences in PUFA level 20:3 n-3
|
0 ug/ml
Standard Deviation 0
|
0 ug/ml
Standard Deviation 0
|
|
PUFA Levels in Red Blood Cells Pre and Post Surgery
Differences in PUFA level 20:5 n-3
|
15066 ug/ml
Standard Deviation 29266
|
-1187 ug/ml
Standard Deviation 28583
|
|
PUFA Levels in Red Blood Cells Pre and Post Surgery
Differences in PUFA level 22:6 n-3
|
42086 ug/ml
Standard Deviation 101629
|
-26551 ug/ml
Standard Deviation 128776
|
|
PUFA Levels in Red Blood Cells Pre and Post Surgery
Difference in PUFA level n-3
|
0 ug/ml
Standard Deviation 0
|
0 ug/ml
Standard Deviation 0
|
|
PUFA Levels in Red Blood Cells Pre and Post Surgery
Difference in PUFA level in n-6
|
0 ug/ml
Standard Deviation 0
|
0 ug/ml
Standard Deviation 0
|
|
PUFA Levels in Red Blood Cells Pre and Post Surgery
Difference in n-3/n-6 ratio
|
0 ug/ml
Standard Deviation 0
|
0 ug/ml
Standard Deviation 0
|
SECONDARY outcome
Timeframe: At time of surgeryANOVA 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.
Outcome measures
| Measure |
Arm I (Omega-3 Fatty Acid)
n=23 Participants
Patients receive omega-3 fatty acid PO daily for 7-14 days.
omega-3 fatty acid: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=19 Participants
Patients receive placebo PO daily for 7-14 days.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
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
|
35.4 ug/ml
Standard Deviation 4412.3
|
|
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
|
6.7 ug/ml
Standard Deviation 15.5
|
|
Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue
Difference in 5HETE
|
7 ug/ml
Standard Deviation 19.6
|
-78.3 ug/ml
Standard Deviation 355.4
|
|
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
|
1.12 ug/ml
Standard Deviation 4.5
|
|
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
|
2.27 ug/ml
Standard Deviation 9.32
|
|
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
|
4.24 ug/ml
Standard Deviation 18.47
|
|
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
|
2308.05 ug/ml
Standard Deviation 4654.22
|
|
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
|
335.48 ug/ml
Standard Deviation 643.24
|
|
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
|
28.12 ug/ml
Standard Deviation 79.73
|
|
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
|
7.87 ug/ml
Standard Deviation 8.86
|
|
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
|
84.07 ug/ml
Standard Deviation 354.6
|
|
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
|
81.15 ug/ml
Standard Deviation 181.54
|
|
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
|
92.01 ug/ml
Standard Deviation 184.18
|
|
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
|
11.49 ug/ml
Standard Deviation 48.06
|
|
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
|
2343.46 ug/ml
Standard Deviation 4379.73
|
|
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
|
350.07 ug/ml
Standard Deviation 655.21
|
|
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
|
95.85 ug/ml
Standard Deviation 190.12
|
|
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
|
14.52 ug/ml
Standard Deviation 15.02
|
|
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
|
5.74 ug/ml
Standard Deviation 7.74
|
|
Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue
Difference in PGE2
|
319 ug/ml
Standard Deviation 868.1
|
80 ug/ml
Standard Deviation 182.1
|
|
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
|
89.7 ug/ml
Standard Deviation 185.6
|
|
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
|
7.3 ug/ml
Standard Deviation 52.5
|
|
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
|
14.6 ug/ml
Standard Deviation 673.4
|
|
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
|
67.7 ug/ml
Standard Deviation 210.4
|
SECONDARY outcome
Timeframe: At time of surgeryANOVA 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.
Outcome measures
| Measure |
Arm I (Omega-3 Fatty Acid)
n=27 Participants
Patients receive omega-3 fatty acid PO daily for 7-14 days.
omega-3 fatty acid: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=25 Participants
Patients receive placebo PO daily for 7-14 days.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Number of Days to Establish Difference in Proliferation in Malignant Breast Tissue
|
23.7 Days on treatment
Standard Deviation 16.6
|
24.2 Days on treatment
Standard Deviation 23.9
|
SECONDARY outcome
Timeframe: At time of surgeryANOVA 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.
Outcome measures
| Measure |
Arm I (Omega-3 Fatty Acid)
n=27 Participants
Patients receive omega-3 fatty acid PO daily for 7-14 days.
omega-3 fatty acid: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=25 Participants
Patients receive placebo PO daily for 7-14 days.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Number of Days to Establish Increased Apoptosis in Malignant Breast Tissue
|
2.6 Days on treatment
Standard Deviation 2.2
|
3.2 Days on treatment
Standard Deviation 2.4
|
Adverse Events
Arm I (Omega-3 Fatty Acid)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Arm II (Placebo)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm I (Omega-3 Fatty Acid)
n=28 participants at risk
Patients receive omega-3 fatty acid PO daily for 7-14 days.
omega-3 fatty acid: Given PO
laboratory biomarker analysis: Correlative studies
|
Arm II (Placebo)
n=27 participants at risk
Patients receive placebo PO daily for 7-14 days.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
|
|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.1%
2/28 • Number of events 2 • 14-21 days after surgery
|
0.00%
0/27 • 14-21 days after surgery
|
|
Injury, poisoning and procedural complications
Seroma
|
3.6%
1/28 • Number of events 1 • 14-21 days after surgery
|
0.00%
0/27 • 14-21 days after surgery
|
|
Eye disorders
Eye disorder
|
3.6%
1/28 • Number of events 1 • 14-21 days after surgery
|
0.00%
0/27 • 14-21 days after surgery
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
3.6%
1/28 • Number of events 1 • 14-21 days after surgery
|
0.00%
0/27 • 14-21 days after surgery
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/28 • 14-21 days after surgery
|
3.7%
1/27 • Number of events 1 • 14-21 days after surgery
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/28 • 14-21 days after surgery
|
3.7%
1/27 • Number of events 1 • 14-21 days after surgery
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/28 • 14-21 days after surgery
|
3.7%
1/27 • Number of events 1 • 14-21 days after surgery
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/28 • 14-21 days after surgery
|
3.7%
1/27 • Number of events 1 • 14-21 days after surgery
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/28 • 14-21 days after surgery
|
3.7%
1/27 • Number of events 1 • 14-21 days after surgery
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/28 • 14-21 days after surgery
|
3.7%
1/27 • Number of events 1 • 14-21 days after surgery
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/28 • 14-21 days after surgery
|
3.7%
1/27 • Number of events 1 • 14-21 days after surgery
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/28 • 14-21 days after surgery
|
3.7%
1/27 • Number of events 1 • 14-21 days after surgery
|
|
Vascular disorders
Phlebitis
|
0.00%
0/28 • 14-21 days after surgery
|
3.7%
1/27 • Number of events 1 • 14-21 days after surgery
|
Additional Information
Edward Levine, MD
Wake Forest University Health Sciences
Phone: 336-716-5440
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place