NCT01849250

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

A Multicenter Phase II Study of Docosahexaenoic Acid (DHA) in Patients With a History of Breast Cancer, Premalignant Lesions, or Benign Breast Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Type	Name	Description
DRUG	Docosahexaenoic Acid	Given PO
OTHER	Placebo	Given PO

Timeline

• Start date: 2013-05-01
• Primary completion: 2016-01-11
• Completion: 2020-04-22
• First posted: 2013-05-08
• Last updated: 2021-12-28
• Results posted: 2021-12-28

Locations

4 sites across 1 country: United States