Breast, Omega 3 Free Fatty Acid, Ph 0

The University of Texas System (UT)

Status: Completed

Conditions: Breastcancer

Treatments: Dietary Supplement: Omega-3 FFA

Study type: Interventional

Funder types: Other

Identifiers

NCT02996240

CTMS 16-0119

16-665H (Other Identifier)

Details and patient eligibility

About

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

Full 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).

Enrollment: 21 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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21 participants in 1 patient group

Omega-3 FFA

Experimental group

Description:

Patients will take 12 capsules daily with meals, divided twice daily (example, 6 with breakfast and 6 with dinner).

Treatment:

Dietary Supplement: Omega-3 FFA