Breast, Omega 3 Free Fatty Acid, Ph 0

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.

Study Overview

• Status: Completed
• Conditions: Breastcancer
• Intervention / Treatment: Dietary supplement: Omega-3 FFA

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • CTRC at University of Texas Health Science Center San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Omega-3 FFA; Patients will take 12 capsules daily with meals, divided twice daily (example, 6 with breakfast and 6 with dinner).	Dietary supplement: Omega-3 FFA; Omega-3 Free Fatty Acid will be given as a fish oil in a capsule.; Other Names: Omacor

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center at San Antonio

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 12, 2017
• Primary Completion (ACTUAL): September 27, 2019
• Study Completion (ACTUAL): February 22, 2021

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: December 14, 2016
• First Posted (ESTIMATE): December 19, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 17, 2021
• Last Update Submitted That Met QC Criteria: March 15, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CTMS 16-0119; 16-665H (OTHER: UTHSCSA)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes