Status:
COMPLETED
Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Ductal Breast Carcinoma in Situ
Lobular Breast Carcinoma in Situ
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 pa...
Detailed Description
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 b...
Eligibility Criteria
Inclusion
- Newly diagnosed stage I to III breast cancer and carcinoma in situ (including lobular carcinoma in situ \[LCIS\] and ductal carcinoma in situ \[DCIS\])
- Breast surgery (lumpectomy or mastectomy) is planned for at least 7 days from the day of enrollment
- Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved written informed consent document
- Tumor measures at least 1 centimeter on imaging or physical exam
Exclusion
- Any patient with surgery scheduled \< 7days after biopsy
- Patients who are unable to refrain from the use of any NSAID or full-dose acetylsalicylic acid (ASA)-containing NSAID while taking study drug
- Patients who will receive neoadjuvant chemotherapy are not eligible
- Patients who are currently taking omega-3 fatty acids, as they are unable to be randomized to placebo
- Patients who have previously taken omega-3 fatty acid within 1 month prior to study enrollment
- Patients with an allergy or known hypersensitivity to fish
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
57 Patients enrolled
Trial Details
Trial ID
NCT01869764
Start Date
November 1 2013
End Date
July 1 2018
Last Update
October 30 2019
Active Locations (1)
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1
Comprehensive Cancer Center of Wake Forest University
Winston-Salem, North Carolina, United States, 27157