Omega-3 Fatty Acid in Treating Patients With Stage I-III Breast Cancer
Completed · Phase 2 · Has a placebo group
Conditions studied: 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
In brief
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 patients receiving omega-3 fatty acid may help doctors learn more about the effects of omega-3 fatty acid on tumor cells.
Key facts
- Study ID
- NCT01869764
- Run by
- Wake Forest University Health Sciences
- People needed
- 57
- Starts
- 2013-11-01
- Expected to finish
- 2018-07-01
- Last updated by the study team
- 2019-10-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Comprehensive Cancer Center of Wake Forest University — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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