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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01869764|
Recruitment Status : Recruiting
First Posted : June 5, 2013
Last Update Posted : January 24, 2018
|Condition or disease||Intervention/treatment|
|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||Dietary Supplement: omega-3 fatty acid Other: placebo Other: laboratory biomarker analysis|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Placebo-Controlled Phase II Clinical Trial of Omega-3 PUFA Dietary Supplementation in Patients With Stage I-III Breast Carcinoma|
|Study Start Date :||November 2013|
|Estimated Primary Completion Date :||November 2018|
U.S. FDA Resources
Experimental: Arm I (omega-3 fatty acid)
Patients receive omega-3 fatty acid PO daily for 7-14 days.
Dietary Supplement: omega-3 fatty acid
Other Names:Other: laboratory biomarker analysis
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO daily for 7-14 days.
Other Name: PLCBOther: laboratory biomarker analysis
- PUFA levels in normal and metastatic breast tissue and in plasma and red blood cells [ Time Frame: At time of 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.
- Metabolites of omega-3 and omega-6 PUFA in malignant and normal breast tissue [ Time Frame: At time of surgery ]ANOVA will be used to assess the effect in normal and malignant breast tissue.
- Proliferation and apoptosis in malignant breast tissue [ Time Frame: At time of surgery ]ANOVA will be used to assess the effect in normal and malignant breast tissue.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01869764
|Contact: Edward Levine, MDemail@example.com|
|United States, North Carolina|
|Comprehensive Cancer Center of Wake Forest University||Recruiting|
|Winston-Salem, North Carolina, United States, 27157|
|Contact: Greg Kucera, PhD 336-716-6348 firstname.lastname@example.org|
|Principal Investigator: Greg Kucera, PhD|
|Principal Investigator:||Edward Levine, MD||Wake Forest University Health Sciences|