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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2013-00963 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| P30CA012197 | U.S. NIH Grant/Contract | View source | |
| CCCWFU 98113 | Other Identifier | NCI |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This phase II clinical trial studies how well omega-3 fatty acid works in treating patients with stage I-III breast cancer. Studying samples of tissue and blood in the laboratory from breast cancer patients receiving omega-3 fatty acid may help doctors learn more about the effects of omega-3 fatty acid on tumor cells.
PRIMARY OBJECTIVES:
I. To determine if omega-3 dietary supplementation (omega-3 fatty acid) results in higher polyunsaturated fatty acids (PUFA) levels in surgical specimens of normal and malignant breast tissue in women who took omega 3 tablets in comparison to those who took placebo.
II. To determine if omega-3 dietary supplementation results in higher PUFA levels in plasma and red blood cells in women who took omega 3 tablets in comparison to those who took placebo.
III. To determine if omega-3 dietary supplementation affects the metabolites of omega-3 and omega-6 PUFA in surgical specimens of malignant and normal breast tissue in comparison to controls.
IV. To determine if women who take omega-3 dietary supplementation have less proliferation and greater apoptosis in malignant breast tissue in comparison to women who take placebo.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive omega-3 fatty acid orally (PO) daily for 7-14 days.
ARM II: Patients receive placebo PO daily for 7-14 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (omega-3 fatty acid) | Experimental | Patients receive omega-3 fatty acid PO daily for 7-14 days. |
|
| Arm II (placebo) | Placebo Comparator | Patients receive placebo PO daily for 7-14 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| omega-3 fatty acid | Drug | Given PO |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| PUFA Levels in Normal and Metastatic Breast Tissue | Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3 | At time of surgery |
| PUFA Levels in Plasma Pre and Post Surgery | Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3 | Pre and post surgery |
| PUFA Levels in Red Blood Cells Pre and Post Surgery | Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3 | Pre and post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | ANOVA will be used to assess the effect in normal and malignant breast tissue. Metabolites tested: PGE2, PGD2, 20-HETE, 5-HEPE, 13-HODE, 9-HODE, 15-HETE, 12-HETE, 5-HETE. | At time of surgery |
| Number of Days to Establish Difference in Proliferation in Malignant Breast Tissue |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Edward Levine, MD | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Comprehensive Cancer Center of Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Arm II (Placebo) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 24, 2015 |
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| placebo | Other | Given PO |
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| laboratory biomarker analysis | Other | Correlative studies |
|
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. |
| At time of surgery |
| Number of Days to Establish Increased Apoptosis in Malignant Breast Tissue | ANOVA will be used to assess the effect of the supplementation in malignant breast tissue with greater apoptosis in malignant breast tissue in comparison to women who took the placebo. | At time of surgery |
Patients receive placebo PO daily for 7-14 days.
placebo: Given PO
laboratory biomarker analysis: Correlative studies
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Arm II (Placebo) | Patients receive placebo PO daily for 7-14 days. placebo: Given PO laboratory biomarker analysis: Correlative studies |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PUFA Levels in Normal and Metastatic Breast Tissue | Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3 | All samples measurements were not available for all participants to be analyzed. | Posted | Mean | Standard Deviation | ug/ml | At time of surgery |
|
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| ||||||||||||||||||||||||||||
| Primary | PUFA Levels in Plasma Pre and Post Surgery | Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3 | All samples measurements were not available for all participants to be analyzed. | Posted | Mean | Standard Deviation | ug/ml | Pre and post surgery |
|
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| Primary | PUFA Levels in Red Blood Cells Pre and Post Surgery | Analysis of variance (ANOVA) will be used to assess the effect of omega-3 dietary supplementation on PUFA levels separately in normal and malignant breast tissue. Analysis of covariance (ANCOVA) will be used to assess the omega-3 effect in plasma and red blood cells (RBC), where the baseline levels of the PUFAs will be included as covariates. PUFA Levels analyzed were 18:2 n-6, 18:3 n-3, 20:2 n-6, 20:4 n-6, 20:3 n-3, 20:5 n-3, 22:6 n-3 | All samples measurements were not available for all participants to be analyzed. | Posted | Mean | Standard Deviation | ug/ml | Pre and post surgery |
|
| |||||||||||||||||||||||||||||
| Secondary | Metabolites of Omega-3 and Omega-6 PUFA in Malignant and Normal Breast Tissue | ANOVA will be used to assess the effect in normal and malignant breast tissue. Metabolites tested: PGE2, PGD2, 20-HETE, 5-HEPE, 13-HODE, 9-HODE, 15-HETE, 12-HETE, 5-HETE. | Posted | Mean | Standard Deviation | ug/ml | At time of surgery |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Days to Establish Difference in Proliferation in Malignant Breast Tissue | ANOVA will be used to assess the effect of the supplementation in malignant breast tissue with less proliferation in malignant breast tissue in comparison to women who took the placebo. | Posted | Mean | Standard Deviation | Days on treatment | At time of surgery |
|
| ||||||||||||||||||||||||||||||
| Secondary | Number of Days to Establish Increased Apoptosis in Malignant Breast Tissue | ANOVA will be used to assess the effect of the supplementation in malignant breast tissue with greater apoptosis in malignant breast tissue in comparison to women who took the placebo. | Posted | Mean | Standard Deviation | Days on treatment | At time of surgery |
|
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14-21 days after surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 28 | 0 | 28 | 2 | 28 |
| EG001 | Arm II (Placebo) | Patients receive placebo PO daily for 7-14 days. placebo: Given PO laboratory biomarker analysis: Correlative studies | 0 | 29 | 0 | 27 | 1 | 27 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | CTCAE (4.0) | Systematic Assessment |
| |
| Eye disorder | Eye disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | CTCAE (4.0) | Systematic Assessment |
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| Lymphocyte count decreased | Investigations | CTCAE (4.0) | Systematic Assessment |
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| Anemia | Blood and lymphatic system disorders | CTCAE (4.0) | Systematic Assessment |
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| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Sinus bradycardia | Cardiac disorders | CTCAE (4.0) | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (4.0) | Systematic Assessment |
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| Breast pain | Reproductive system and breast disorders | CTCAE (4.0) | Systematic Assessment |
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| Phlebitis | Vascular disorders | CTCAE (4.0) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edward Levine, MD | Wake Forest University Health Sciences | 336-716-5440 | elevine@wakehealth.edu |
| Aug 23, 2019 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 28, 2018 | Aug 23, 2019 | ICF_001.pdf |
| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D000071960 | Breast Carcinoma In Situ |
| D018567 | Breast Neoplasms, Male |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D015525 | Fatty Acids, Omega-3 |
| D005395 | Fish Oils |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D009821 | Oils |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Normal breast tissue 18:3 n-3 |
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| Normal breast tissue 20:2 n-6 |
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| Normal breast tissue 20:4 n-6 |
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| Normal breast tissue 20:3 n-3 |
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| Normal breast tissue 20:5 n-3 |
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| Normal breast tissue 22:6 n-3 |
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| Normal breast tissue n-3 |
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| Normal breast tissue n-6 |
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| Normal breast tissue n3/n-6 ratio |
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| Malignant breast tissue 18:2 n-6 |
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| Malignant breast 18:3 n-3 |
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| Malignant breast 20:2 n-6 |
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| Malignant breast 20:4 n-6 |
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| Malignant breast 20:3 n-3 |
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| Malignant breast 20:5 n-3 |
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| Malignant breast 22:6 n-3 |
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| Malignant breast n-3 |
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| Malignant breast n-6 |
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| Malignant breast n-3/n-6 ratio |
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| Differences in PUFA level 18:2 n-6 |
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| Differences in PUFA level 18:3 n-3 |
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| Differences in PUFA level 20:2 n-6 |
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| Differences in PUFA level 20:4 n-6 |
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| Differences in PUFA level 20:3 n-3 |
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| Differences in PUFA level 20:5 n-3 |
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| Differences in PUFA level 22:6 n-3 |
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| Difference in PUFA level n-3 |
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| Difference in PUFA level in n-6 |
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| Difference in n-3/n-6 ratio |
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