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Completed

NCT Number: NCT02996240

Breast, Omega 3 Free Fatty Acid, Ph 0

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

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Key information

Conditions

Breastcancer

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CTRC at University of Texas Health Science Center San Antonio

San Antonio, Texas, 78229, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Omega-3 FFA

Dietary Supplement

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

Other names: Omacor

Primary outcomes

  1. Change in serum colony stimulating factor at surgery

    Time frame: 30 days

  2. Change in circulating levels of pro-inflammatory cytokines.

    Time frame: 30 days

  3. Change in circulating levels of eicosanoids.

    Time frame: 30 days

  4. Change in circulating levels of metabolics.

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center at San Antonio

Other

Registry information

Official study title

A Phase 0, Investigator Initiated Study, Evaluating the Impact of Omega 3 Free Fatty Acid Supplementation on Breast Cancer (CTMS# 16-0119)

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
Dec 19, 2016
Registry last updated
Mar 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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