NCT02996240

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 19, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

June 12, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2019

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 22, 2021

Completed
Last Updated

March 17, 2021

Status Verified

March 1, 2021

Enrollment Period

2.3 years

First QC Date

December 12, 2016

Last Update Submit

March 15, 2021

Conditions

Breastcancer

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (1)

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

Omega-3 FFADIETARY_SUPPLEMENT

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

Also known as: Omacor
Omega-3 FFA

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CTRC at University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Interventions

Omacor

Study Officials

  • Virginia G Kaklamani, MD

    Principal Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 12, 2016

First Posted

December 19, 2016

Study Start

June 12, 2017

Primary Completion

September 27, 2019

Study Completion

February 22, 2021

Last Updated

March 17, 2021

Record last verified: 2021-03

Locations

US(1)