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NCT02996240 Clinical Trial

Breast, Omega 3 Free Fatty Acid, Ph 0

Breastcancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02996240
Other study ID # CTMS 16-0119
Secondary ID 16-665H
Status Completed
Phase N/A
First received
Last updated
Start date June 12, 2017
Est. completion date February 22, 2021

Study information
Verified date March 2021
Source The University of Texas Health Science Center at San Antonio
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility
Status Completed
Enrollment 21
Est. completion date February 22, 2021
Est. primary completion date September 27, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Omega-3 FFA
Omega-3 Free Fatty Acid will be given as a fish oil in a capsule.

Locations
Country Name City State
United States CTRC at University of Texas Health Science Center San Antonio San Antonio Texas

Sponsors (1)
Lead Sponsor Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in serum colony stimulating factor at surgery 30 days
Primary Change in circulating levels of pro-inflammatory cytokines. 30 days
Primary Change in circulating levels of eicosanoids. 30 days
Primary Change in circulating levels of metabolics. 30 days
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