Breast, Omega 3 Free Fatty Acid, Ph 0

Not Applicable

Completed

• Conditions: Breastcancer
• Interventions: Dietary Supplement: Omega-3 FFA

• Registration Number: NCT02996240
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief Summary

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

Detailed Description

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).

Study Timeline

• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2016-12-14
• Study First Posted: 2016-12-19
• Study Start: 2017-06-12
• Primary Completion: 2019-09-27
• Study Completion: 2021-02-22
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-15
• Last Update Posted: 2021-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Omega-3 FFA	Omega-3 FFA	Patients will take 12 capsules daily with meals, divided twice daily (example, 6 with breakfast and 6 with dinner).

Primary Outcome Measures

Name	Time	Method
Change in serum colony stimulating factor at surgery	30 days
Change in circulating levels of metabolics.	30 days
Change in circulating levels of eicosanoids.	30 days
Change in circulating levels of pro-inflammatory cytokines.	30 days

Trial Locations

Locations (1)

CTRC at University of Texas Health Science Center San Antonio; 🇺🇸 San Antonio, Texas, United States