Docosahexaenoic Acid in Preventing Recurrence in Breast Cancer Survivors
|ClinicalTrials.gov Identifier: NCT01849250|
Recruitment Status : Active, not recruiting
First Posted : May 8, 2013
Last Update Posted : June 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Benign Breast Neoplasm Ductal Breast Carcinoma In Situ Invasive Breast Carcinoma Lobular Breast Carcinoma In Situ Paget Disease of the Breast Stage IA Breast Cancer Stage IB Breast Cancer Stage IIA Breast Cancer Stage IIB Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer||Drug: Docosahexaenoic Acid Other: Laboratory Biomarker Analysis Other: Placebo||Phase 2|
I. To determine whether treatment with docosahexaenoic acid (DHA) for 12 weeks at 1000 mg twice daily as compared to placebo reduces normal breast tissue levels of tumor necrosis factor-alpha (TNF-alpha) in overweight and obese patients with a history of stage I-III invasive breast cancer, ductal carcinoma in situ (DCIS), Paget's disease, lobular carcinoma in situ (LCIS), or proliferative benign breast disease.
I. To investigate the effect of DHA at 1000 mg twice daily on tissue biomarkers
- Change from the baseline in cyclooxygenase-2 (COX-2)/interleukin-1-beta (IL-1beta)/aromatase measured by quantitative real-time polymerase chain reaction (PCR).
- Change from the baseline in crown-like structures of the breast (CLS-B) measured by immunohistochemical techniques for cluster of differentiation (CD)68.
- Change from baseline in CLS-B index determined as follows: ([number of slides with evidence of at least one CLS-B]/[total number of slides examined]).
- Change from baseline in CLS-B/cm^2 defined as the number of CLS-B/cm^2. II. Evaluate age as a predictor of CLS-B and inflammatory biomarkers (TNF-alpha/COX-2/IL-1beta) at baseline and over the time of treatment.
III. Evaluate red blood cell (RBC) fatty acid level as a surrogate of compliance.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive docosahexaenoic acid orally (PO) twice daily (BID) for 12 weeks.
ARM II: Patients receive placebo PO BID for 12 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter Phase II Study of Docosahexaenoic Acid (DHA) in Patients With a History of Breast Cancer, Premalignant Lesions, or Benign Breast Disease|
|Study Start Date :||May 2013|
|Primary Completion Date :||January 2016|
U.S. FDA Resources
Experimental: Arm I (docosahexaenoic acid)
Patients receive docosahexaenoic acid PO BID for 12 weeks.
Drug: Docosahexaenoic Acid
Other Name: Fatty Acid 22:6Other: Laboratory Biomarker Analysis
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO BID for 12 weeks.
Other: Laboratory Biomarker Analysis
Correlative studiesOther: Placebo
- Percent change in normal breast tissue TNF-alpha levels [ Time Frame: Baseline to 12 weeks ]Differences between active treatment and placebo arm will be compared using analysis of covariance where the post-treatment measurements will be used as a dependent variable and the pretreatment measurements will be included as a covariate in the analysis. Two-sided student t-test or the nonparametric Wilcoxon rank-sum test will be used where appropriate.
- Absolute change in CLS-B index defined as follows (number of slides with at least one CLS-B)/(total number of slides examined) measured by immunohistochemical techniques for CD68 [ Time Frame: Baseline to 12 weeks ]Fisher's exact test will be used.
- Absolute change in CLS-B/cm^2 adjusted for the pre-treatment measurements [ Time Frame: Baseline to 12 weeks ]
- Absolute change in the presence of CLS-B measured by immunohistochemical techniques for CD68 [ Time Frame: Baseline to 12 weeks ]Fisher's exact test will be used.
- Percent change in the breast tissue mRNA levels of tissue biomarkers [ Time Frame: Baseline to 12 weeks ]Biomarkers (COX-2/IL-1beta/aromatase) are measured by quantitative real-time PCR. Paired t-test or one-sample Wilcoxon rank-sum test will be used.
- RBC fatty acid level as a surrogate of compliance [ Time Frame: Up to 12 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01849250
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02115|
|United States, New York|
|Columbia University/Herbert Irving Cancer Center|
|New York, New York, United States, 10032|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ayca Gucalp||M.D. Anderson Cancer Center|