Breast, Omega 3 Free Fatty Acid, Ph 0

NCT ID: NCT02996240

Last Updated: 2021-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-12

Study Completion Date

2021-02-22

Brief Summary

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

Detailed Description

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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).

Conditions

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Breastcancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Omega-3 FFA

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

Group Type EXPERIMENTAL

Omega-3 FFA

Intervention Type DIETARY_SUPPLEMENT

Omega-3 Free Fatty Acid will be given as a fish oil in a capsule.

Interventions

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Omega-3 FFA

Omega-3 Free Fatty Acid will be given as a fish oil in a capsule.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Omacor

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center at San Antonio

OTHER

Sponsor Role lead

Responsible Party

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Virginia G. Kaklamani

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Virginia G Kaklamani, MD

Role: PRINCIPAL_INVESTIGATOR

Principal Investigator

Locations

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CTRC at University of Texas Health Science Center San Antonio

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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16-665H

Identifier Type: OTHER

Identifier Source: secondary_id

CTMS 16-0119

Identifier Type: -

Identifier Source: org_study_id

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