Breast, Omega 3 Free Fatty Acid, Ph 0



Status:Recruiting
Conditions:Breast Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:2/3/2019
Start Date:June 12, 2017
End Date:February 2020
Contact:Epp Goodwin
Email:ctrcreferral@uthscsa.edu
Phone:210-450-5798

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A Phase 0, Investigator Initiated Study, Evaluating the Impact of Omega 3 Free Fatty Acid Supplementation on Breast Cancer (CTMS# 16-0119)

Assess the impact of dietary omega 3 free fatty acids breast cancer patients.

Prospective, single arm, short term study with correlative biomarker endpoints. Two hundred
(200) newly diagnosed breast cancer patients will be recruited to participate in a short term
(30 day) Phase 0 biomarker evaluation study prior to surgical resection. Patients will be
receive fish Oil (Omega-3 FFAs, 2700 mg by mouth twice daily).

Inclusion Criteria:

- At least 18 years of age

- ECOG ≤2

- Ability to understand the purposes and risks of the study and has signed a written
informed consent form approved by the investigator's IRB/Ethics Committee

- Consented for tissue collection on CTRC repository 07-32

Exclusion Criteria:

- Active systemic illness (infection including viral illnesses such as Hepatitis and
HIV)

- Chronic use of NSAIDs or omega-3 free fatty acid supplementation within the last 60
days (defined as greater than or equal to 7 consecutive days)

- Any NSAIDs or omega-3 free fatty acid supplementation within the last 14 days

- History of medical noncompliance

- Scheduled date of surgical resection that would limit the amount of time taking the
intervention to less than 21 days
We found this trial at
1
site
San Antonio, Texas 78229
Phone: 210-450-3838
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