Trial · NCT00723398

Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention

NCT00723398, Not applicable, Completed, Milton S. Hershey Medical Center; results first posted 2018-11-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention. Trials, record NCT00723398. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00723398

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention
NCT number: NCT00723398
Status: Completed
Phases: Not applicable
Enrollment: 266 participants, actual
Lead sponsor: Milton S. Hershey Medical Center
Conditions: Breast Cancer
Interventions: Lovaza 4gm oral, Raloxifene 60 Mg Oral Tablet, Raloxifene 30 Mg Oral Tablet, Lovaza 4gm & Raloxifene 30mg
First posted: 2008-07-28
Last updated: 2018-11-01
Results first posted: 2018-11-01

Source ClinicalTrials.gov

Registered outcomes11

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Absolute Breast Density	2 years	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.
Secondary	Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α	1 year	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.
Secondary	Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine	1 year	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.
Secondary	Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1)	1 year	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).
Secondary	Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6)	1 Year	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).
Secondary	Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3)	1 year	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).
Secondary	Changes in Serum Lipid Levels	2 years	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.
Secondary	Changes in Complete Blood Count: Red Blood Cells	2 years	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.
Secondary	Changes in Complete Blood Count: Hemoglobin	2 years	Changes in complete blood count levels as measured through hemoglobin. Specific time points for evaluation are baseline, Year +1, and Year 2.
Secondary	Changes in Complete Blood Count: Hematocrit	2 years	Changes in complete blood count levels as measured through hematocrit percentage. Specific time points for evaluation are baseline, Year +1, and Year 2.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Absolute Breast Density	2 years	The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.	cm squared	MEAN
SECONDARY	Changes in Biomarkers for Oxidative Stress:Urinary 8-(Isoprostane) F-2α	1 year	Biomarker measurements were not taken for the entire population of the study due to non-significant trends for treatment effects found in this population (n = 47).	pg/mg creatinine	MEAN
SECONDARY	Changes in Biomarkers for Oxidative Stress: Urinary 8-hydroxy-deoxyguansine	1 year	Biomarker measurements were not taken for the entire population of the study due to non-significant trends for treatment effects found in this population (n = 47).	ng/mg creatinine	MEAN
SECONDARY	Changes in Biomarkers for Estrogen Metabolism: 2-hydroxy Estrone (Urinary 2-OHE1) and 16-α-hydroxy Estrone (16α-OHE1)	1 year	Biomarker measurements were not taken for the entire population of the study due to non-significant trends for treatment effects found in this population (n = 47).	ng/mg creatinine	MEAN
SECONDARY	Changes in Serum Biomarkers for Inflammation From Levels of High Sensitivity C-reactive Protein (hsCRP) and Interleukin 6 (IL-6)	1 Year	Biomarker measurements were not taken for the entire population of the study (N = 266) due to non-significant trends for treatment effects found in this initial population (n = 89).	pg/ml	MEAN
SECONDARY	Changes in Insulin-like Growth Factor-1 (IGF-1) and Insulin-like Growth Factor-1 Binding Protein-3 (IGFBP-3)	1 year	Measurements were not taken for the entire population of the study due to non-significant trends for treatment effects found in this population (n = 46).	ng/mL	MEAN
SECONDARY	Changes in Serum Lipid Levels	2 years	The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.	mg/dL	MEAN
SECONDARY	Changes in Complete Blood Count: Red Blood Cells	2 years	The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.	millions of cells per microliter	MEAN
SECONDARY	Changes in Complete Blood Count: Hemoglobin	2 years	The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.	g/dL	MEAN
SECONDARY	Changes in Complete Blood Count: Hematocrit	2 years	The decrease in the population groups is accounted for through subject withdrawals, subjects lost to follow-up, and other reasons for not completing study.	volume percentage	MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group230

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change in Absolute Breast Density	Group 1: Control	Absolute density at baseline	65.53	Standard Deviation 59.43	cm squared
Change in Absolute Breast Density	Group 2: Raloxifene 60 mg	Absolute density at baseline	64.39	Standard Deviation 39.95	cm squared
Change in Absolute Breast Density	Group 3: Raloxifene 30 mg	Absolute density at baseline	65.08	Standard Deviation 34.47	cm squared
Change in Absolute Breast Density	Group 4: Lovaza 4 gm	Absolute density at baseline	56.35	Standard Deviation 22.61	cm squared
Change in Absolute Breast Density	Group 5: Lovaza 4 gm and Raloxifene 30 mg	Absolute density at baseline	63.81	Standard Deviation 29.81	cm squared
Change in Absolute Breast Density	Group 1: Control	Absolute density at 1 year	59.29	Standard Deviation 40.72	cm squared
Change in Absolute Breast Density	Group 2: Raloxifene 60 mg	Absolute density at 1 year	60.48	Standard Deviation 38.89	cm squared
Change in Absolute Breast Density	Group 3: Raloxifene 30 mg	Absolute density at 1 year	59.53	Standard Deviation 30.32	cm squared
Change in Absolute Breast Density	Group 4: Lovaza 4 gm	Absolute density at 1 year	58.87	Standard Deviation 22.21	cm squared
Change in Absolute Breast Density	Group 5: Lovaza 4 gm and Raloxifene 30 mg	Absolute density at 1 year	60.93	Standard Deviation 24.64	cm squared

1 to 10 of 230Source ClinicalTrials.gov

See all 230 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Group 1: Control	53
Overall Study	STARTED	Group 2: Raloxifene 60 mg	53
Overall Study	STARTED	Group 3: Raloxifene 30 mg	53
Overall Study	STARTED	Group 4: Lovaza 4 gm	54
Overall Study	STARTED	Group 5: Lovaza 4 gm and Raloxifene 30 mg	53
Overall Study	COMPLETED	Group 1: Control	47
Overall Study	COMPLETED	Group 2: Raloxifene 60 mg	38
Overall Study	COMPLETED	Group 3: Raloxifene 30 mg	36
Overall Study	COMPLETED	Group 4: Lovaza 4 gm	49
Overall Study	COMPLETED	Group 5: Lovaza 4 gm and Raloxifene 30 mg	44

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events35

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hot flashes	Endocrine disorders	Group 1: Control	0	53	0
other	Hot flashes	Endocrine disorders	Group 2: Raloxifene 60 mg	10	53	10
other	Hot flashes	Endocrine disorders	Group 3: Raloxifene 30 mg	7	53	7
other	Hot flashes	Endocrine disorders	Group 4: Lovaza 4 gm	0	54	0
other	Hot flashes	Endocrine disorders	Group 5: Lovaza 4 gm and Raloxifene 30 mg	6	53	6
other	Night Sweating (diaphoresis)	General disorders	Group 1: Control	0	53	0
other	Night Sweating (diaphoresis)	General disorders	Group 2: Raloxifene 60 mg	6	53	6
other	Night Sweating (diaphoresis)	General disorders	Group 3: Raloxifene 30 mg	3	53	3
other	Night Sweating (diaphoresis)	General disorders	Group 4: Lovaza 4 gm	0	54	0
other	Night Sweating (diaphoresis)	General disorders	Group 5: Lovaza 4 gm and Raloxifene 30 mg	2	53	2

1 to 10 of 35Source ClinicalTrials.gov

See all 35 adverse events

Adverse event totals15

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Group 1: Control
Total, all-cause mortality	Group 2: Raloxifene 60 mg
Total, all-cause mortality	Group 3: Raloxifene 30 mg
Total, all-cause mortality	Group 4: Lovaza 4 gm
Total, all-cause mortality	Group 5: Lovaza 4 gm and Raloxifene 30 mg
Total, other adverse events	Group 1: Control	1	53
Total, other adverse events	Group 2: Raloxifene 60 mg	10	53
Total, other adverse events	Group 3: Raloxifene 30 mg	7	53
Total, other adverse events	Group 4: Lovaza 4 gm	0	54
Total, other adverse events	Group 5: Lovaza 4 gm and Raloxifene 30 mg	6	53

1 to 10 of 15Source ClinicalTrials.gov

See all 15 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28145413	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00723398

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