Spots Global Cancer Trial Database for Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors

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Trial Identification

Brief Title: Study of Docosahexaenoic Acid (DHA) in Triple Negative Breast Cancer Survivors

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 ID: NCT01849250

Conditions

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

Interventions

Docosahexaenoic Acid

Placebo

Study Description

Brief Summary: This randomized phase II trial studies how well docosahexaenoic acid works in preventing recurrence in breast cancer survivors. Docosahexaenoic acid supplement may prevent recurrence in breast cancer survivors.

Detailed Description: PRIMARY OBJECTIVES: 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. SECONDARY OBJECTIVES: 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.