Breast, Omega 3 Free Fatty Acid, Ph 0 | NCT02996240

Studies
Breast, Omega 3 Free Fatty Acid, Ph 0

NCT02996240

Sponsor

The University of Texas Health Science Center at San Antonio

Status

Completed

Last Update Posted

Mar 17, 2021Actual

Enrollment

21Actual

Phase

Not Applicable

Conditions

Breastcancer

Interventions

Omega-3 FFA

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
16-665H	Other Identifier	UTHSCSA

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 12, 2017Actual

Primary Completion Date

Sep 27, 2019Actual

Completion Date

Feb 22, 2021Actual

First Submitted Date

Dec 12, 2016

First Submission Date that Met QC Criteria

Dec 14, 2016

First Posted Date

Dec 19, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2021

Last Update Posted Date

Mar 17, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Virginia G. Kaklamani, Principal Investigator, The University of Texas Health Science Center at San AntonioPrincipal Investigator

Lead Sponsor

The University of Texas Health Science Center at San AntonioOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

21Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Omega-3 FFA	Experimental	Patients will take 12 capsules daily with meals, divided twice daily (example, 6 with breakfast and 6 with dinner).	Dietary Supplement: Omega-3 FFA

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Omega-3 FFA	Dietary Supplement	Omega-3 Free Fatty Acid will be given as a fish oil in a capsule.	Omega-3 FFA

Outcomes Module

Primary Outcomes

Measure	Description	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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Virginia G Kaklamani, MD	Principal Investigator	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CTRC at University of Texas Health Science Center San Antonio		San Antonio	Texas	78229	United States

Intervention Browse Module

MeSH Terms

ID	Term
C405603	Omacor

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided