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Trial record 1 of 1 for:    NCT02996240
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Breast, Omega 3 Free Fatty Acid, Ph 0

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02996240
Recruitment Status : Recruiting
First Posted : December 19, 2016
Last Update Posted : February 1, 2019
Information provided by (Responsible Party):
Virginia G. Kaklamani, The University of Texas Health Science Center at San Antonio

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

Condition or disease Intervention/treatment Phase
Breastcancer Dietary Supplement: Omega-3 FFA Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 0, Investigator Initiated Study, Evaluating the Impact of Omega 3 Free Fatty Acid Supplementation on Breast Cancer (CTMS# 16-0119)
Actual Study Start Date : June 12, 2017
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: Omega-3 FFA
Patients will take 12 capsules daily with meals, divided twice daily (example, 6 with breakfast and 6 with dinner).
Dietary Supplement: Omega-3 FFA
Omega-3 Free Fatty Acid will be given as a fish oil in a capsule.
Other Name: Omacor

Primary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02996240

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Contact: Epp Goodwin 210-450-5798

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United States, Texas
CTRC at University of Texas Health Science Center San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Virginia Kaklamani, MD    210-450-3838   
Contact: Epp Goodwin    210-450-5798   
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
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Principal Investigator: Virginia G Kaklamani, MD Principal Investigator

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Responsible Party: Virginia G. Kaklamani, Principal Investigator, The University of Texas Health Science Center at San Antonio Identifier: NCT02996240     History of Changes
Other Study ID Numbers: CTMS 16-0119
16-665H ( Other Identifier: UTHSCSA )
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases