Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 99 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

CTRC at University of Texas Health Science Center San Antonio
San Antonio, Texas 78229
Contact:
Virginia Kaklamani, MD
210-450-3838
kaklamani@uthscsa.edu

More Details

NCT ID
NCT02996240
Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Epp Goodwin
210-450-5798
ctrcreferral@uthscsa.edu

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).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.