CompletedNCT00723398Updated Nov 1, 2018Results posted

Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention

An interventional study of Lovaza 4gm oral and Raloxifene 60 Mg Oral Tablet in Breast Cancer, sponsored by Milton S. Hershey Medical Center. Completed at 1 site in United States. Open to female participants aged 35 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-01.

Sponsored by Milton S. Hershey Medical Center · Not applicable, Interventional, and Prevention

Phase: Not applicable
Study type: Interventional
Enrollment: 266
Allocation: Randomized
Ages: 35 Years to 70 Years
Sex: Female

Study summary

The overall hypothesis is that the combination of a low dose of the antiestrogen Raloxifene with omega-3 fatty acids will exert a synergistic breast cancer chemopreventive effect due to the crosstalk of their downstream cellular effects leading to decreased proliferation and increased apoptosis of premalignant mammary cells. Based on the investigators hypothesis that upregulation of functional estrogen receptors in the premalignant lesions is also responsible for the development of hormone independent tumors, the investigators postulate that the combination of antiestrogens and omega-3 fatty acids will reduce the development of both hormone-dependent and -independent tumors. At present, there are no known interventions able to decrease the development of hormone-independent tumors, which are more prevalent, more aggressive, leading to the patient's demise. In addition, the investigators postulate that this approach will be safe since it will combine a lower and hence a less toxic dose of Raloxifene with the administration of omega-3 fatty acids which are known to have health benefits, i.e., reduction in cardiovascular risk, beyond their possible chemo preventive effect in breast cancer.

Read the detailed description

The main objectives of this study are to determine the individual and combined effects of Raloxifene and omega-3 fatty acids on surrogate markers of breast cancer development in healthy, postmenopausal women. The primary endpoint will be mammographic density for which the study has been powered. Breast density is a major risk factor for breast cancer and hence it is chosen to evaluate the potential chemopreventive efficacy of our interventions. Secondary endpoints would include markers of oxidative stress, parameters of estrogen metabolism, markers of inflammation, and markers of IGF-I signaling, all of which have been shown in the literature to have an influence on mammary carcinogenesis.

Study Population: Healthy, postmenopausal women between the ages of 35-70 years, undergoing yearly mammograms as part of routine screening practice.

Method of Identification of Subjects/Samples/Medical Records: Women reporting for yearly mammograms will be considered for this protocol. They will be given first a screening questionnaire to rule out any co-existing medical condition that would predispose them to thromboembolic events.

Conditions studied

Breast Cancer

Browse trials for

Breast Neoplasms 12,544

Keywords

omega-3 fatty acids
antiestrogens
breast cancer prevention
breast density
biomarkers of mammary carcinogenesis

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 266 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Milton S. Hershey Medical Center is the lead sponsor of 480 studies on the registry; 61 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 42 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 35 Years to 70 Years
Sexes eligible: Female
Accepts healthy volunteers: Yes

Inclusion criteria

Postmenopausal status defined as history of at least 12 months without spontaneous menstrual bleeding or a documented hysterectomy and bilateral salpingo oophorectomy
Breast density greater than 25%
No hormone replacement therapy for at least six months prior to entry into this study
Non-smokers.

Exclusion criteria

Exclusion Criteria:

History of stroke, pulmonary embolism or deep vein thrombosis
History of atherosclerotic heart disease
Presence of any known hypercoagulable state either congenital (e.g., protein S deficiency) or acquired (e.g., corticosteroid treatment)
Diabetes mellitus
Uncontrolled hypertension (BP ≥140/90)
Presence of a psychiatric condition that would interfere with adherence to the protocol.

Study design

Phase: Not applicable
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 266 participants (actual)

Study arms

No intervention
Group 1: Control
Control, no intervention
Experimental
Group 2: Raloxifene 60 Mg Oral Tablet
Raloxifene 60 mg Orally Daily
Drug: Raloxifene 60 Mg Oral Tablet
Experimental
Group 3: Raloxifene 30 Mg Oral Tablet
Raloxifene 30 mg Orally Daily
Drug: Raloxifene 30 Mg Oral Tablet
Experimental
Group 4: Lovaza 4 gm oral
Lovaza 4 gm/day Orally with Meals
Dietary Supplement: Lovaza 4gm oral
Experimental
Group 5: Lovaza 4gm & Raloxifene 30mg
Lovaza 4 gm/day oral capsule with meals plus Raloxifene 30 mg oral tablet daily
Drug: Lovaza 4gm & Raloxifene 30mg

Interventions

Dietary supplementLovaza 4gm oral
Dietary supplement; Take 4 mg oral capsules daily
Also known as: Omega-3 Fatty Acid Capsules; Fish Oil capsules; Triklo
DrugRaloxifene 60 Mg Oral Tablet
60 mg orally every day for two years
Also known as: Evista 60 Mg Oral Tablet
DrugRaloxifene 30 Mg Oral Tablet
30 mg orally daily for two years
Also known as: Evista 30 Mg Oral Tablet
DrugLovaza 4gm & Raloxifene 30mg
Lovaza 4gm and Raloxifene 30 Mg orally once per day for 2 years
Also known as: Pitavastatin 4 gm and Evista 30 mg oral tablet

What researchers measure

Primary outcomes

Change in Absolute Breast Density
Change of absolute breast density as indicated by mammography from baseline to Year +1 and completion of study (Year +2). No other mammograms will be obtained or used for the purpose of this study. Absolute breast density volume is based on breast thickness and the x-ray attenuation at each pixel of the image.
Time frame: 2 years

Secondary outcomes

Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α
Changes in biomarkers for oxidative stress. Specific time points for evaluation are baseline and Year +1 (only). Urinary 8-(isoprostane) F-2α as measured through urine analysis.
Time frame: 1 year
Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine
Changes in biomarkers for oxidative stress. Specific time points for evaluation are baseline and Year +1 (only). Urinary 8-hydroxy-deoxyguansine as measured through urinary analysis.
Time frame: 1 year
Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1)
Changes in biomarkers for estrogen metabolism: 2-hydroxy estrone (Urinary 2-OHE1) and 16-α-hydroxy estrone (16α-OHE1) as measured by urinary analysis. Specific time points for evaluation are baseline and Year +1 (only).
Time frame: 1 year
Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6)
Changes in serum biomarkers for inflammation including highly sensitive C-reactive protein and IL-6 obtained through a blood draw. Specific time points for evaluation are baseline and Year +1 (only).
Time frame: 1 Year
Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3)
Changes in insulin-like growth factor-1 (IGF-1) and insulin-like growth factor-1 binding protein-3 (IGFBP-3) obtained through blood sample. Specific time points for evaluation are baseline and Year +1 (only).
Time frame: 1 year
Changes in Serum Lipid Levels
Changes in serum lipid levels as measured through total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides. Specific time points for evaluation are baseline, Year +1, and Year 2.
Time frame: 2 years
Changes in Complete Blood Count: Red Blood Cells
Changes in complete blood count levels as measured through red blood cells (RBC). Specific time points for evaluation are baseline, Year +1, and Year 2.
Time frame: 2 years
Changes in Complete Blood Count: Hemoglobin
Changes in complete blood count levels as measured through hemoglobin. Specific time points for evaluation are baseline, Year +1, and Year 2.
Time frame: 2 years
Changes in Complete Blood Count: Hematocrit
Changes in complete blood count levels as measured through hematocrit percentage. Specific time points for evaluation are baseline, Year +1, and Year 2.
Time frame: 2 years
Changes in Complete Blood Count: White Blood Cells and Platelets
Changes in complete blood count levels as measured through white blood cells (WBC) and platelets. Specific time points for evaluation are baseline, Year +1, and Year 2.
Time frame: 2 years

Results

Posted Nov 1, 2018

Participant flow

Participant flow — Overall Study
Milestone	Group 1: Control	Group 2: Raloxifene 60 mg	Group 3: Raloxifene 30 mg	Group 4: Lovaza 4 gm	Group 5: Lovaza 4 gm and Raloxifene 30 mg
Started	53	53	53	54	53
Completed	47	38	36	49	44
Not completed	6	15	17	5	9
Withdrew: Withdrawal by subject	2	6	4	4	4
Withdrew: Protocol violation	2	1	5	0	0
Withdrew: Physician decision	2	2	5	0	1
Withdrew: Adverse event	0	5	3	1	4
Withdrew: Lost to follow-up	0	1	0	0	0

Outcome measures

PrimaryChange in Absolute Breast Density

Change of absolute breast density as indicated by mammography from baseline to Year +1 and completion of study (Year +2). No other mammograms will be obtained or used for the purpose of this study. Absolute breast density volume is based on breast thickness and the x-ray attenuation at each pixel of the image.

Time frame:: 2 years
Reported as:: Mean · cm squared

Change in Absolute Breast Density
cm squared	Group 1: Control	Group 2: Raloxifene 60 mg	Group 3: Raloxifene 30 mg	Group 4: Lovaza 4 gm	Group 5: Lovaza 4 gm and Raloxifene 30 mg
Absolute density at baseline	65.53 ± 59.43	64.39 ± 39.95	65.08 ± 34.47	56.35 ± 22.61	63.81 ± 29.81
Absolute density at 1 year	59.29 ± 40.72	60.48 ± 38.89	59.53 ± 30.32	58.87 ± 22.21	60.93 ± 24.64
Absolute density at 2 years	54.34 ± 20.11	60.57 ± 35.10	58.86 ± 27.93	57.60 ± 20.77	28.53 ± 25.18

SecondaryChanges in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α

Changes in biomarkers for oxidative stress. Specific time points for evaluation are baseline and Year +1 (only). Urinary 8-(isoprostane) F-2α as measured through urine analysis.

Time frame:: 1 year
Reported as:: Mean · pg/mg creatinine

Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α
pg/mg creatinine	Group 1: Control	Group 2: Raloxifene 60 mg	Group 3: Raloxifene 30 mg	Group 4: Lovaza 4 gm	Group 5: Lovaza 4 gm and Raloxifene 30 mg
Baseline	544 ± 105	366 ± 39.7	530 ± 107	440 ± 30.8	444 ± 54.6
1 year	484 ± 77.3	360 ± 33.8	538 ± 67.0	313 ± 45.1	396 ± 40.6

SecondaryChanges in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine

Changes in biomarkers for oxidative stress. Specific time points for evaluation are baseline and Year +1 (only). Urinary 8-hydroxy-deoxyguansine as measured through urinary analysis.

Time frame:: 1 year
Reported as:: Mean · ng/mg creatinine

Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine
ng/mg creatinine	Group 1: Control	Group 2: Raloxifene 60 mg	Group 3: Raloxifene 30 mg	Group 4: Lovaza 4 gm	Group 5: Lovaza 4 gm and Raloxifene 30 mg
Baseline	255 ± 63.6	285 ± 47.7	213 ± 91.0	184 ± 25.6	355 ± 79.7
1 year	224 ± 31.8	309 ± 69.0	246 ± 108	177 ± 17.3	297 ± 90.2

SecondaryChanges in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1)

Changes in biomarkers for estrogen metabolism: 2-hydroxy estrone (Urinary 2-OHE1) and 16-α-hydroxy estrone (16α-OHE1) as measured by urinary analysis. Specific time points for evaluation are baseline and Year +1 (only).

Time frame:: 1 year
Reported as:: Mean · ng/mg creatinine

Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1)
ng/mg creatinine	Group 1: Control	Group 2: Raloxifene 60 mg	Group 3: Raloxifene 30 mg	Group 4: Lovaza 4 gm	Group 5: Lovaza 4 gm and Raloxifene 30 mg
Baseline: Urinary 2-OHE1	10.57 ± 2.3	8.58 ± 1.0	8.82 ± 1.4	7.15 ± 1.1	15.6 ± 4.5
1 year: Urinary 2-OHE1	7.46 ± 1.4	10.03 ± 1.0	9.10 ± 1.4	7.49 ± 1.0	13.2 ± 3.7
Baseline: 16α-OHE1	6.22 ± 0.7	5.08 ± 0.5	6.86 ± 1.8	5.24 ± 0.5	6.6 ± 0.9
1 year: 16α-OHE1	5.68 ± 0.7	4.35 ± 0.5	7.46 ± 1.4	4.79 ± 0.3	5.68 ± 0.9

SecondaryChanges in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6)

Changes in serum biomarkers for inflammation including highly sensitive C-reactive protein and IL-6 obtained through a blood draw. Specific time points for evaluation are baseline and Year +1 (only).

Time frame:: 1 Year
Reported as:: Mean · pg/ml

Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6)
pg/ml	Group 1: Control	Group 2: Raloxifene 60 mg	Group 3: Raloxifene 30 mg	Group 4: Lovaza 4 gm	Group 5: Lovaza 4 gm and Raloxifene 30 mg
Baseline: Serum hsCRP	2.39 ± 0.87	0.91 ± 0.26	1.67 ± 0.63	1.22 ± 0.31	4.28 ± 1.61
1 year: Serum hsCRP	2.19 ± 0.63	1.04 ± 0.34	1.34 ± 0.34	1.69 ± 0.59	2.59 ± 0.89
Baseline: Serum IL-6	1.27 ± 0.3	1.14 ± 0.23	1.04 ± 0.22	1.32 ± 0.45	1.84 ± 0.52
1 year: Serum IL-6	1.03 ± 0.19	1.13 ± 0.26	1.11 ± 0.2	1.49 ± 0.41	1.32 ± 0.34

SecondaryChanges in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3)

Changes in insulin-like growth factor-1 (IGF-1) and insulin-like growth factor-1 binding protein-3 (IGFBP-3) obtained through blood sample. Specific time points for evaluation are baseline and Year +1 (only).

Time frame:: 1 year
Reported as:: Mean · ng/mL

Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3)
ng/mL	Group 1: Control	Group 2: Raloxifene 60 mg	Group 3: Raloxifene 30 mg	Group 4: Lovaza 4 gm	Group 5: Lovaza 4 gm and Raloxifene 30 mg
Baseline: IGF-1	4.96 ± 0.37	4.63 ± 0.28	4.80 ± 0.23	4.95 ± 0.41	4.89 ± 0.49
1 year: IGF-1	5.05 ± 0.44	4.40 ± 0.25	4.76 ± 0.24	4.96 ± 031	4.82 ± 0.52
Baseline: IGFBP-3	7.67 ± 0.32	7.53 ± 0.19	7.69 ± 0.21	7.83 ± 0.20	7.57 ± 0.23
1 year: IGFBP-3	7.75 ± 0.26	7.55 ± 0.12	7.79 ± 0.24	7.83 ± 0.17	7.61 ± 0.23

SecondaryChanges in Serum Lipid Levels

Changes in serum lipid levels as measured through total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, and triglycerides. Specific time points for evaluation are baseline, Year +1, and Year 2.

Time frame:: 2 years
Reported as:: Mean · mg/dL

Changes in Serum Lipid Levels
mg/dL	Group 1: Control	Group 2: Raloxifene 60 mg	Group 3: Raloxifene 30 mg	Group 4: Lovaza 4 gm	Group 5: Lovaza 4 gm and Raloxifene 30 mg
Baseline: Total Cholesterol	207.3 ± 41.18	203.6 ± 29.98	204.3 ± 36.29	197.7 ± 33.2	197.6 ± 38.68
1 year: Total Cholestrol	208.8 ± 34.39	198.3 ± 29.33	199.6 ± 28.43	199.6 ± 30.45	189.4 ± 33.45
2 year: Total Cholesterol	207.5 ± 36.41	196.6 ± 30.64	202.3 ± 25.58	200.2 ± 34.55	192.6 ± 30.02
Baseline: LDL Cholesterol	114 ± 38.07	114.7 ± 27.53	111.2 ± 31.83	106.6 ± 31.96	108.1 ± 35.87
1 year: LDL Cholesterol	115.1 ± 31.99	106.8 ± 25.98	106.2 ± 24.38	109.7 ± 29.22	96.58 ± 26.37
2 year: LDL Cholesterol	115.3 ± 29.21	104.7 ± 28.13	106.1 ± 25.4	110.4 ± 29.2	99.48 ± 25.2
Baseline: HDL Cholesterol	68.75 ± 18.83	66.18 ± 15.47	70.92 ± 18.54	68.06 ± 16.89	68.9 ± 17.68
1 year: HDL Cholesterol	70.71 ± 18.87	68.88 ± 14.06	70.59 ± 16.63	70.59 ± 18.31	76.11 ± 18.61
2 year: HDL Cholestrol	70.19 ± 19.35	68.63 ± 15.04	73.17 ± 18.01	70.67 ± 19.38	75.77 ± 17.8
Baseline: Triglycerides	122.7 ± 54.57	113.2 ± 48.39	110.6 ± 50.49	115.1 ± 52.33	103.6 ± 38.79
1 year: Triglycerides	114.5 ± 62.95	113.2 ± 55.08	113.7 ± 49.76	96.22 ± 42.94	83.71 ± 31.08
2 year: Triglycerides	110.1 ± 44.25	116.9 ± 50.17	115.8 ± 58.48	95.41 ± 49.6	86.43 ± 35

SecondaryChanges in Complete Blood Count: Red Blood Cells

Changes in complete blood count levels as measured through red blood cells (RBC). Specific time points for evaluation are baseline, Year +1, and Year 2.

Time frame:: 2 years
Reported as:: Mean · millions of cells per microliter

Changes in Complete Blood Count: Red Blood Cells
millions of cells per microliter	Group 1: Control	Group 2: Raloxifene 60 mg	Group 3: Raloxifene 30 mg	Group 4: Lovaza 4 gm	Group 5: Lovaza 4 gm and Raloxifene 30 mg
Baseline: RBC	4.31 ± 0.33	4.25 ± 0.30	4.30 ± 0.33	4.33 ± 0.43	4.24 ± 0.31
1 year: RBC	4.27 ± 0.32	4.19 ± 0.25	4.25 ± 0.30	4.36 ± 0.44	4.20 ± 0.32
2 year: RBC	4.32 ± 0.36	4.20 ± 0.23	4.24 ± 0.35	4.33 ± 0.45	4.23 ± 0.31

SecondaryChanges in Complete Blood Count: Hemoglobin

Changes in complete blood count levels as measured through hemoglobin. Specific time points for evaluation are baseline, Year +1, and Year 2.

Time frame:: 2 years
Reported as:: Mean · g/dL

Changes in Complete Blood Count: Hemoglobin
g/dL	Group 1: Control	Group 2: Raloxifene 60 mg	Group 3: Raloxifene 30 mg	Group 4: Lovaza 4 gm	Group 5: Lovaza 4 gm and Raloxifene 30 mg
Baseline: Hemoglobin	13.09 ± 1.56	13.11 ± 1.48	12.73 ± 2.02	13.25 ± 0.99	13.35 ± 0.86
1 year: Hemoglobin	12.97 ± 1.49	12.97 ± 1.61	12.95 ± 0.96	13.33 ± 0.97	13.10 ± 1.65
2 year: Hemoglobin	13.10 ± 0.87	13.07 ± 0.71	12.82 ± 0.96	13.16 ± 0.91	13.22 ± 0.95

SecondaryChanges in Complete Blood Count: Hematocrit

Changes in complete blood count levels as measured through hematocrit percentage. Specific time points for evaluation are baseline, Year +1, and Year 2.

Time frame:: 2 years
Reported as:: Mean · volume percentage

Changes in Complete Blood Count: Hematocrit
volume percentage	Group 1: Control	Group 2: Raloxifene 60 mg	Group 3: Raloxifene 30 mg	Group 4: Lovaza 4 gm	Group 5: Lovaza 4 gm and Raloxifene 30 mg
Baseline: Hematocrit	39.14 ± 2.50	38.95 ± 2.49	38.79 ± 3.06	39.09 ± 2.70	39.20 ± 2.48
1 year: Hematocrit	38.83 ± 2.25	38.79 ± 2.14	38.43 ± 2.69	39.52 ± 2.72	39.14 ± 2.52
2 year: Hematocrit	39.00 ± 2.47	38.86 ± 2.28	38.31 ± 2.84	38.59 ± 5.72	39.14 ± 2.74

SecondaryChanges in Complete Blood Count: White Blood Cells and Platelets

Changes in complete blood count levels as measured through white blood cells (WBC) and platelets. Specific time points for evaluation are baseline, Year +1, and Year 2.

Time frame:: 2 years
Reported as:: Mean · thousand cells/mL

Changes in Complete Blood Count: White Blood Cells and Platelets
thousand cells/mL	Group 1: Control	Group 2: Raloxifene 60 mg	Group 3: Raloxifene 30 mg	Group 4: Lovaza 4 gm	Group 5: Lovaza 4 gm and Raloxifene 30 mg
Baseline: WBC	5.13 ± 1.29	5.47 ± 1.57	5.00 ± 1.20	5.04 ± 1.64	5.27 ± 1.24
1 year: WBC	5.15 ± 1.76	5.51 ± 1.54	4.78 ± 1.04	4.95 ± 1.37	4.91 ± 1.18
2 year: WBC	5.14 ± 1.32	5.42 ± 1.39	4.90 ± 1.10	4.90 ± 1.26	4.91 ± 1.19
Baseline: Platelets	270.70 ± 277.46	235.22 ± 52.06	240.42 ± 41.32	237.33 ± 51.41	235.76 ± 53.07
1 year: Platelets	237.02 ± 55.05	228.02 ± 50.71	230.61 ± 39.40	231.42 ± 49.58	221.49 ± 55.50
2 year: Platelets	234.02 ± 47.55	226.16 ± 51.14	232.09 ± 44.10	232.47 ± 54.22	223.27 ± 49.18

Adverse events

Collected over Participants who did not meet an off study criterion were followed until 2 years post initiation of the study medication regimen.. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Group 1: Control	—	0/53 (0%)	1/53 (1.9%)
Group 2: Raloxifene 60 mg	—	1/53 (1.9%)	10/53 (18.9%)
Group 3: Raloxifene 30 mg	—	0/53 (0%)	7/53 (13.2%)
Group 4: Lovaza 4 gm	—	0/54 (0%)	0/54 (0%)
Group 5: Lovaza 4 gm and Raloxifene 30 mg	—	0/53 (0%)	6/53 (11.3%)

Most frequent serious events

Most frequent serious events
Event	Group 1: Control	Group 2: Raloxifene 60 mg	Group 3: Raloxifene 30 mg	Group 4: Lovaza 4 gm	Group 5: Lovaza 4 gm and Raloxifene 30 mg
Endometrial CancerReproductive system and breast disorders	0/53	1/53	0/53	0/54	0/53

Most frequent other events

Most frequent other events
Event	Group 1: Control	Group 2: Raloxifene 60 mg	Group 3: Raloxifene 30 mg	Group 4: Lovaza 4 gm	Group 5: Lovaza 4 gm and Raloxifene 30 mg
Hot flashesEndocrine disorders	0/53	10/53	7/53	0/54	6/53
Night Sweating (diaphoresis)General disorders	0/53	6/53	3/53	0/54	2/53
Leg crampingGeneral disorders	0/53	4/53	0/53	0/54	1/53
RosaceaSkin and subcutaneous tissue disorders	1/53	2/53	0/53	0/54	1/53
Vaginal SpottingReproductive system and breast disorders	0/53	2/53	0/53	0/54	1/53
HeadacheNervous system disorders	0/53	2/53	1/53	0/54	1/53

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Group 1: Control	Group 2: Raloxifene 60 mg	Group 3: Raloxifene 30 mg	Group 4: Lovaza 4 gm	Group 5: Lovaza 4 gm and Raloxifene 30 mg	Total
<=18 years	0	0	0	0	0	0
Between 18 and 65 years	49	43	48	45	46	231
>=65 years	4	10	5	9	7	35

Sex: Female, Male
Sex: Female, Male(Participants)	Group 1: Control	Group 2: Raloxifene 60 mg	Group 3: Raloxifene 30 mg	Group 4: Lovaza 4 gm	Group 5: Lovaza 4 gm and Raloxifene 30 mg	Total
Female	53	53	53	54	53	266
Male	0	0	0	0	0	0

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Group 1: Control	Group 2: Raloxifene 60 mg	Group 3: Raloxifene 30 mg	Group 4: Lovaza 4 gm	Group 5: Lovaza 4 gm and Raloxifene 30 mg	Total
Hispanic or Latino	1	0	0	1	0	2
Not Hispanic or Latino	52	53	53	53	53	264
Unknown or Not Reported	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Group 1: Control	Group 2: Raloxifene 60 mg	Group 3: Raloxifene 30 mg	Group 4: Lovaza 4 gm	Group 5: Lovaza 4 gm and Raloxifene 30 mg	Total
American Indian or Alaska Native	0	0	0	0	0	0
Asian	1	0	0	1	0	2
Native Hawaiian or Other Pacific Islander	0	0	0	1	0	1
Black or African American	1	1	1	1	0	4
White	51	52	52	51	53	259
More than one race	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0

Study locations

1 site

Penn State Hershey Medical Center
Hershey, Pennsylvania 17033, United States

References and documents

Publications

Manni A, Richie JP, Schetter SE, Calcagnotto A, Trushin N, Aliaga C, El-Bayoumy K. Stearoyl-CoA desaturase-1, a novel target of omega-3 fatty acids for reducing breast cancer risk in obese postmenopausal women. Eur J Clin Nutr. 2017 Jun;71(6):762-765. doi: 10.1038/ejcn.2016.273. Epub 2017 Feb 1. PubMed 28145413 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Nov 1, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00723398
Lead sponsor: Milton S. Hershey Medical Center
Responsible party: Andrea Manni (Professor and Chief Division of Endocrinology, Diabetes, and Metabolism, Milton S. Hershey Medical Center) — Principal investigator
First posted: Jul 28, 2008
Start date: Mar 2009
Primary completion: Apr 2015
Completion: Apr 2015
Results posted: Nov 1, 2018
Last update: Nov 1, 2018

Study contacts

Andrea Manni, MD

principal investigator · Penn State University

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Breast Neoplasms→

Other studies from this sponsor

Milton S. Hershey Medical Center

Start the discussion