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Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01869764
Recruitment Status : Completed
First Posted : June 5, 2013
Results First Posted : October 30, 2019
Last Update Posted : October 30, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions 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
Interventions Drug: omega-3 fatty acid
Other: placebo
Other: laboratory biomarker analysis
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I (Omega-3 Fatty Acid) Arm II (Placebo)
Hide Arm/Group Description

Patients receive omega-3 fatty acid PO daily for 7-14 days.

omega-3 fatty acid: Given PO

laboratory biomarker analysis: Correlative studies

Patients receive placebo PO daily for 7-14 days.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

Period Title: Overall Study
Started 28 29
Completed 28 27
Not Completed 0 2
Reason Not Completed
Withdrawal by Subject             0             2
Arm/Group Title Arm I (Omega-3 Fatty Acid) Arm II (Placebo) Total
Hide Arm/Group Description

Patients receive omega-3 fatty acid PO daily for 7-14 days.

omega-3 fatty acid: Given PO

laboratory biomarker analysis: Correlative studies

Patients receive placebo PO daily for 7-14 days.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

Total of all reporting groups
Overall Number of Baseline Participants 28 29 57
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 28 participants 29 participants 57 participants
57.8  (14.0) 59.9  (9.5) 58.8  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 29 participants 57 participants
Female
28
 100.0%
29
 100.0%
57
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 29 participants 57 participants
Hispanic or Latino
1
   3.6%
1
   3.4%
2
   3.5%
Not Hispanic or Latino
27
  96.4%
28
  96.6%
55
  96.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 29 participants 57 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
4
  14.3%
4
  13.8%
8
  14.0%
White
23
  82.1%
23
  79.3%
46
  80.7%
More than one race
1
   3.6%
0
   0.0%
1
   1.8%
Unknown or Not Reported
0
   0.0%
2
   6.9%
2
   3.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 28 participants 29 participants 57 participants
28 29 57
1.Primary Outcome
Title PUFA Levels in Normal and Metastatic Breast Tissue
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All samples measurements were not available for all participants to be analyzed.
Arm/Group Title Arm I (Omega-3 Fatty Acid) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive omega-3 fatty acid PO daily for 7-14 days.

omega-3 fatty acid: Given PO

laboratory biomarker analysis: Correlative studies

Patients receive placebo PO daily for 7-14 days.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 22 19
Mean (Standard Deviation)
Unit of Measure: ug/ml
Normal breast tissue 18:2 n-6 Number Analyzed 22 participants 19 participants
60.986  (40.392) 72.762  (50.742)
Normal breast tissue 18:3 n-3 Number Analyzed 22 participants 19 participants
3.232  (2.289) 3.505  (2.041)
Normal breast tissue 20:2 n-6 Number Analyzed 22 participants 19 participants
1.104  (0.96) 1.008  (0.724)
Normal breast tissue 20:4 n-6 Number Analyzed 22 participants 19 participants
2.221  (1.349) 2.342  (1.445)
Normal breast tissue 20:3 n-3 Number Analyzed 22 participants 19 participants
0.049  (0.107) 0.038  (0.085)
Normal breast tissue 20:5 n-3 Number Analyzed 22 participants 19 participants
0.027  (0.128) 0.034  (0.147)
Normal breast tissue 22:6 n-3 Number Analyzed 22 participants 19 participants
0.095  (0.443) 0.061  (0.264)
Normal breast tissue n-3 Number Analyzed 22 participants 19 participants
3.402  (2.572) 3.64  (2.24)
Normal breast tissue n-6 Number Analyzed 22 participants 19 participants
3.421  (2.085) 3.413  (1.962)
Normal breast tissue n3/n-6 ratio Number Analyzed 21 participants 19 participants
0.948  (0.468) 1.102  (0.438)
Malignant breast tissue 18:2 n-6 Number Analyzed 22 participants 19 participants
44.137  (44.544) 33.735  (31.548)
Malignant breast 18:3 n-3 Number Analyzed 22 participants 19 participants
1.943  (2.162) 1.356  (1.465)
Malignant breast 20:2 n-6 Number Analyzed 22 participants 19 participants
0.889  (0.886) 0.601  (0.657)
Malignant breast 20:4 n-6 Number Analyzed 22 participants 19 participants
3.208  (1.948) 2.248  (1.744)
Malignant breast 20:3 n-3 Number Analyzed 22 participants 19 participants
0.034  (0.087) 0  (0)
Malignant breast 20:5 n-3 Number Analyzed 22 participants 19 participants
0.2  (0.665) 0  (0)
Malignant breast 22:6 n-3 Number Analyzed 22 participants 19 participants
0  (0) 0  (0)
Malignant breast n-3 Number Analyzed 22 participants 19 participants
2.178  (2.41) 1.357  (1.466)
Malignant breast n-6 Number Analyzed 22 participants 19 participants
48.233  (46.105) 36.586  (32.856)
Malignant breast n-3/n-6 ratio Number Analyzed 22 participants 19 participants
0.029  (0.031) 0.032  (0.016)
Differences in PUFA level 18:2 n-6 Number Analyzed 22 participants 19 participants
-16.85  (51.043) -39.027  (38.697)
Differences in PUFA level 18:3 n-3 Number Analyzed 22 participants 19 participants
-1.289  (2.784) -2.149  (1.935)
Differences in PUFA level 20:2 n-6 Number Analyzed 22 participants 19 participants
-0.215  (0.866) -0.407  (0.514)
Differences in PUFA level 20:4 n-6 Number Analyzed 22 participants 19 participants
0.986  (1.595) -0.094  (1.589)
Differences in PUFA level 20:3 n-3 Number Analyzed 22 participants 19 participants
-0.015  (0.105) -0.038  (0.085)
Differences in PUFA level 20:5 n-3 Number Analyzed 22 participants 19 participants
0.173  (0.545) -0.034  (0.147)
Differences in PUFA level 22:6 n-3 Number Analyzed 22 participants 19 participants
-0.095  (0.443) -0.061  (0.264)
Difference in PUFA level n-3 Number Analyzed 22 participants 19 participants
-1.224  (2.794) -2.282  (2.127)
Difference in PUFA level in n-6 Number Analyzed 22 participants 19 participants
44.812  (45.463) 33.173  (31.836)
Difference in n-3/n-6 ratio Number Analyzed 21 participants 19 participants
-0.92  (0.45) -1.07  (0.438)
2.Primary Outcome
Title PUFA Levels in Plasma Pre and Post Surgery
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All samples measurements were not available for all participants to be analyzed.
Arm/Group Title Arm I (Omega-3 Fatty Acid) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive omega-3 fatty acid PO daily for 7-14 days.

omega-3 fatty acid: Given PO

laboratory biomarker analysis: Correlative studies

Patients receive placebo PO daily for 7-14 days.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 24 19
Mean (Standard Deviation)
Unit of Measure: ug/ml
Plasma pre-surgery 18:2 n-6 Number Analyzed 24 participants 19 participants
1514890  (370945) 1539300  (370726)
Plasma pre-surgery 18:3 n-3 Number Analyzed 24 participants 19 participants
37501  (25256) 33119  (19368)
Plasma pre-surgery 20:2 n-6 Number Analyzed 24 participants 19 participants
7039  (6213) 6031  (5612)
Plasma pre-surgery 20:4 n-6 Number Analyzed 24 participants 19 participants
210238  (77734) 210006  (83260)
Plasma pre-surgery 20:3 n-3 Number Analyzed 24 participants 19 participants
0  (0) 0  (0)
Plasma pre-surgery 20:5 n-3 Number Analyzed 24 participants 19 participants
38539  (30967) 50206  (41170)
Plasma pre-surgery 22:6 n-3 Number Analyzed 24 participants 19 participants
132887  (68619) 111798  (79889)
Plasma pre-surgery n-3 Number Analyzed 24 participants 19 participants
208297  (105288) 195123  (106007)
Plasma pre-surgery n-6 Number Analyzed 24 participants 19 participants
1732167  (373713) 1755338  (397402)
Plasma pre-surgery n3/n-6 ratio Number Analyzed 24 participants 19 participants
0.121  (0.058) 0.11  (0.049)
Plasma post-surgery 18:2 n-6 Number Analyzed 23 participants 18 participants
1504732  (497732) 1507750  (419001.5)
Plasma post-surgery 18:3 n-3 Number Analyzed 23 participants 18 participants
37472  (18521) 34202.78  (15615)
Plasma post-surgery 20:2 n-6 Number Analyzed 23 participants 18 participants
5980  (5351) 6851.409  (5479.023)
Plasma post-surgery 20:4 n-6 Number Analyzed 23 participants 18 participants
168100  (63105) 204127.2  (85101.33)
Plasma post-surgery 20:3 n-3 Number Analyzed 23 participants 18 participants
0  (0) 0  (0)
Plasma post-surgery 20:5 n-3 Number Analyzed 23 participants 18 participants
74521  (48954) 52643.85  (32019.8)
Plasma post-surgery 22:6 n-3 Number Analyzed 23 participants 18 participants
153607  (83888) 133832.8  (74361.31)
Plasma post-surgery n-3 Number Analyzed 23 participants 18 participants
265600  (134862) 220679.4  (108607.5)
Plasma post-surgery n-6 Number Analyzed 23 participants 18 participants
1678812  (538264) 1718729  (448393)
Plasma post-surgery n-3/n-6 ratio Number Analyzed 23 participants 18 participants
0.16  (0.067) 0.126  (0.049)
Differences in PUFA level 18:2 n-6 Number Analyzed 23 participants 18 participants
-23266  (602402) -34877  (365683)
Differences in PUFA level 18:3 n-3 Number Analyzed 23 participants 18 participants
-554  (36051) 1583  (20838)
Differences in PUFA level 20:2 n-6 Number Analyzed 23 participants 18 participants
-824  (7018) 485  (5683)
Differences in PUFA level 20:4 n-6 Number Analyzed 23 participants 18 participants
-37844  (87910) -8045  (69960)
Differences in PUFA level 20:3 n-3 Number Analyzed 23 participants 18 participants
0  (0) 0  (0)
Differences in PUFA level 20:5 n-3 Number Analyzed 23 participants 18 participants
35551  (38628) 2291  (25409)
Differences in PUFA level 22:6 n-3 Number Analyzed 23 participants 18 participants
21487  (68743) 19001  (72461)
Difference in PUFA level n-3 Number Analyzed 23 participants 18 participants
56484  (119807) 22874  (83246)
Difference in PUFA level in n-6 Number Analyzed 23 participants 18 participants
-61935  (653885) -42437  (414325)
Difference in n-3/n-6 ratio Number Analyzed 23 participants 18 participants
0.039  (0.056) 0.015  (0.041)
3.Primary Outcome
Title PUFA Levels in Red Blood Cells Pre and Post Surgery
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All samples measurements were not available for all participants to be analyzed.
Arm/Group Title Arm I (Omega-3 Fatty Acid) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive omega-3 fatty acid PO daily for 7-14 days.

omega-3 fatty acid: Given PO

laboratory biomarker analysis: Correlative studies

Patients receive placebo PO daily for 7-14 days.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 20 18
Mean (Standard Deviation)
Unit of Measure: ug/ml
Red blood cells pre-surgery 18:2 n-6 Number Analyzed 20 participants 18 participants
351125  (130630) 387455  (119089)
Red blood cells pre-surgery 18:3 n-3 Number Analyzed 20 participants 18 participants
3430  (4505) 3211  (4026)
Red blood cells pre-surgery 20:2 n-6 Number Analyzed 20 participants 18 participants
2826  (3515) 4014  (4183)
Red blood cells pre-surgeryy 20:4 n-6 Number Analyzed 20 participants 18 participants
132624  (68691) 144208  (71426)
Red blood cells pre-surgery 20:3 n-3 Number Analyzed 20 participants 18 participants
0  (0) 0  (0)
Red blood cells pre-surgery 20:5 n-3 Number Analyzed 20 participants 18 participants
9723  (13112) 11005  (14840)
Red blood cells pre-surgery 22:6 n-3 Number Analyzed 20 participants 18 participants
79934  (77518) 90668  (74168)
Red blood cells pre-surgery n-3 Number Analyzed 20 participants 18 participants
0  (0) 0  (0)
Red blood cells pre-surgery n-6 Number Analyzed 20 participants 18 participants
0  (0) 0  (0)
Red blood cells pre-surgery n3/n-6 ratio Number Analyzed 20 participants 18 participants
0  (0) 0  (0)
Red blood cells post-surgery 18:2 n-6 Number Analyzed 19 participants 18 participants
391882  (183779) 373679  (103361)
Red blood cells post-surgery 18:3 n-3 Number Analyzed 19 participants 18 participants
5320  (4709) 2103  (5007)
Red blood cells post-surgery 20:2 n-6 Number Analyzed 19 participants 18 participants
3922  (3941) 1842  (3315)
Red blood cells post-surgery 20:4 n-6 Number Analyzed 19 participants 18 participants
149267  (70598) 116868  (73523)
Red blood cells post-surgery 20:3 n-3 Number Analyzed 19 participants 18 participants
0  (0) 0  (0)
Red blood cells post-surgery 20:5 n-3 Number Analyzed 19 participants 18 participants
25301  (29112) 9818  (20929)
Red blood cells post-surgery 22:6 n-3 Number Analyzed 19 participants 18 participants
110198  (90038) 64117  (96118)
Red blood cells post-surgery n-3 Number Analyzed 19 participants 18 participants
0  (0) 0  (0)
Red blood cells post-surgery n-6 Number Analyzed 19 participants 18 participants
0  (0) 0  (0)
Red blood cells post-surgery n-3/n-6 ratio Number Analyzed 19 participants 18 participants
0  (0) 0  (0)
Differences in PUFA level 18:2 n-6 Number Analyzed 19 participants 18 participants
35856  (213680) -13776  (134998)
Differences in PUFA level 18:3 n-3 Number Analyzed 19 participants 18 participants
1709  (4746) -1109  (5750)
Differences in PUFA level 20:2 n-6 Number Analyzed 19 participants 18 participants
948  (3481) -2172  (5204)
Differences in PUFA level 20:4 n-6 Number Analyzed 19 participants 18 participants
23282  (94096) -27340  (117792)
Differences in PUFA level 20:3 n-3 Number Analyzed 19 participants 18 participants
0  (0) 0  (0)
Differences in PUFA level 20:5 n-3 Number Analyzed 19 participants 18 participants
15066  (29266) -1187  (28583)
Differences in PUFA level 22:6 n-3 Number Analyzed 19 participants 18 participants
42086  (101629) -26551  (128776)
Difference in PUFA level n-3 Number Analyzed 19 participants 18 participants
0  (0) 0  (0)
Difference in PUFA level in n-6 Number Analyzed 19 participants 18 participants
0  (0) 0  (0)
Difference in n-3/n-6 ratio Number Analyzed 19 participants 18 participants
0  (0) 0  (0)
4.Secondary Outcome
Title Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Omega-3 Fatty Acid) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive omega-3 fatty acid PO daily for 7-14 days.

omega-3 fatty acid: Given PO

laboratory biomarker analysis: Correlative studies

Patients receive placebo PO daily for 7-14 days.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 23 19
Mean (Standard Deviation)
Unit of Measure: ug/ml
Normal breast tissue PGE2 9.14  (24.59) 1.12  (4.5)
Normal breast tissue PGD2 4.47  (16.17) 2.27  (9.32)
Normal breast tissue 20HETE 1.43  (6.87) 4.24  (18.47)
Normal breast tissue 13HODE 4881.23  (11979.79) 2308.05  (4654.22)
Normal breast tissue 9HODE 729.38  (1789.68) 335.48  (643.24)
Normal breast tissue 15HETE 13.99  (28.41) 28.12  (79.73)
Normal breast tissue 12HETE 12.05  (11.37) 7.87  (8.86)
Normal breast tissue 5HETE 4.75  (4.47) 84.07  (354.6)
Malignant breast tissue PGE2 328.12  (884.633) 81.15  (181.54)
Malignant breast tissue PGD2 335.88  (894.77) 92.01  (184.18)
Malignant breast tissue 20HETE 11.52  (44.5) 11.49  (48.06)
Malignant breast tissue 13HODE 4584.87  (10465.02) 2343.46  (4379.73)
Malignant breast tissue 9HODE 694.78  (1611.17) 350.07  (655.21)
Malignant breast tissue 15HETE 91.11  (199.85) 95.85  (190.12)
Malignant breast tissue 12HETE 79.17  (233.57) 14.52  (15.02)
Malignant breast tissue 5HETE 11.7  (21.91) 5.74  (7.74)
Difference in PGE2 319  (868.1) 80  (182.1)
Difference in PGD2 331.4  (896.4) 89.7  (185.6)
Difference in 20HETE 10.1  (45.4) 7.3  (52.5)
Difference in 13HODE -296.4  (4812.1) 35.4  (4412.3)
Difference in 9HODE -34.6  (761.9) 14.6  (673.4)
Difference in 15HETE 77.1  (191.4) 67.7  (210.4)
Difference in 12HETE 67.1  (229.4) 6.7  (15.5)
Difference in 5HETE 7  (19.6) -78.3  (355.4)
5.Secondary Outcome
Title Number of Days to Establish Difference in Proliferation in Malignant Breast Tissue
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Omega-3 Fatty Acid) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive omega-3 fatty acid PO daily for 7-14 days.

omega-3 fatty acid: Given PO

laboratory biomarker analysis: Correlative studies

Patients receive placebo PO daily for 7-14 days.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: Days on treatment
23.7  (16.6) 24.2  (23.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Omega-3 Fatty Acid), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
6.Secondary Outcome
Title Number of Days to Establish Increased Apoptosis in Malignant Breast Tissue
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I (Omega-3 Fatty Acid) Arm II (Placebo)
Hide Arm/Group Description:

Patients receive omega-3 fatty acid PO daily for 7-14 days.

omega-3 fatty acid: Given PO

laboratory biomarker analysis: Correlative studies

Patients receive placebo PO daily for 7-14 days.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

Overall Number of Participants Analyzed 27 25
Mean (Standard Deviation)
Unit of Measure: Days on treatment
2.6  (2.2) 3.2  (2.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I (Omega-3 Fatty Acid), Arm II (Placebo)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.29
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame 14-21 days after surgery
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm I (Omega-3 Fatty Acid) Arm II (Placebo)
Hide Arm/Group Description

Patients receive omega-3 fatty acid PO daily for 7-14 days.

omega-3 fatty acid: Given PO

laboratory biomarker analysis: Correlative studies

Patients receive placebo PO daily for 7-14 days.

placebo: Given PO

laboratory biomarker analysis: Correlative studies

All-Cause Mortality
Arm I (Omega-3 Fatty Acid) Arm II (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/28 (0.00%)      0/29 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I (Omega-3 Fatty Acid) Arm II (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/28 (0.00%)      0/27 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I (Omega-3 Fatty Acid) Arm II (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/28 (7.14%)      1/27 (3.70%)    
Blood and lymphatic system disorders     
Anemia  1  0/28 (0.00%)  0 1/27 (3.70%)  1
Cardiac disorders     
Sinus bradycardia  1  0/28 (0.00%)  0 1/27 (3.70%)  1
Eye disorders     
Eye disorder  1  1/28 (3.57%)  1 0/27 (0.00%)  0
Gastrointestinal disorders     
Diarrhea  1  0/28 (0.00%)  0 1/27 (3.70%)  1
Constipation  1  0/28 (0.00%)  0 1/27 (3.70%)  1
Injury, poisoning and procedural complications     
Seroma  1  1/28 (3.57%)  1 0/27 (0.00%)  0
Investigations     
Lymphocyte count decreased  1  0/28 (0.00%)  0 1/27 (3.70%)  1
Metabolism and nutrition disorders     
Hyperglycemia  1  2/28 (7.14%)  2 0/27 (0.00%)  0
Nervous system disorders     
Peripheral sensory neuropathy  1  0/28 (0.00%)  0 1/27 (3.70%)  1
Reproductive system and breast disorders     
Breast pain  1  0/28 (0.00%)  0 1/27 (3.70%)  1
Respiratory, thoracic and mediastinal disorders     
Pneumothorax  1  0/28 (0.00%)  0 1/27 (3.70%)  1
Skin and subcutaneous tissue disorders     
Skin disorder  1  1/28 (3.57%)  1 0/27 (0.00%)  0
Vascular disorders     
Phlebitis  1  0/28 (0.00%)  0 1/27 (3.70%)  1
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Edward Levine, MD
Organization: Wake Forest University Health Sciences
Phone: 336-716-5440
EMail: elevine@wakehealth.edu
Layout table for additonal information
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01869764     History of Changes
Other Study ID Numbers: IRB00023419
NCI-2013-00963 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA012197 ( U.S. NIH Grant/Contract )
CCCWFU 98113 ( Other Identifier: NCI )
First Submitted: May 31, 2013
First Posted: June 5, 2013
Results First Submitted: August 1, 2019
Results First Posted: October 30, 2019
Last Update Posted: October 30, 2019