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Impact of Omega 3 Fatty Acid Supplementation on Aromatase in Obese Subjects

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ClinicalTrials.gov Identifier: NCT02538484
Recruitment Status : Recruiting
First Posted : September 2, 2015
Last Update Posted : August 29, 2022
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center at San Antonio

Tracking Information
First Submitted Date  ICMJE August 11, 2015
First Posted Date  ICMJE September 2, 2015
Last Update Posted Date August 29, 2022
Study Start Date  ICMJE April 2016
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2015)
  • Change in levels of aromatase target gene. [ Time Frame: 30 Days ]
  • Change in serum levels of PGE2 (prostaglandin E2). [ Time Frame: 30 Days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of Omega 3 Fatty Acid Supplementation on Aromatase in Obese Subjects
Official Title  ICMJE A Phase 0, Investigator Initiated Study, Evaluating the Impact of Omega 3 Fatty Acid Supplementation on Aromatase in Obese Postmenopausal Women With Estrogen Receptor Positive Breast Cancer
Brief Summary Assess the impact of dietary omega 3 free fatty acids and/or letrozole on obese, postmenopausal breast cancer patients.
Detailed Description Prospective, comparative, three arm, short term, non-interventional study with correlative biomarker endpoints. Sixty (60) obese (≥ 30 BMI) newly diagnosed ER+ postmenopausal breast cancer patients will be recruited to participate in a short term (30 day) Phase 0 biomarker evaluation study prior to surgical resection.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Drug: Letrozole
    Aromatase inhibitor
    Other Name: Femara
  • Dietary Supplement: Fish Oil
    Omega-3 free fatty acid
    Other Name: Omega-3
Study Arms  ICMJE
  • Active Comparator: Letrozole
    Letrozole 2.5 mg by mouth daily for 30 days.
    Intervention: Drug: Letrozole
  • Active Comparator: Fish Oil
    Fish oil 2700 mg by mouth daily for 30 days.
    Intervention: Dietary Supplement: Fish Oil
  • Active Comparator: Letrozole and Fish Oil
    Letrozole 2.5 mg and Fish oil 2700 mg by mouth daily for 30 days.
    Interventions:
    • Drug: Letrozole
    • Dietary Supplement: Fish Oil
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 31, 2015)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2024
Estimated Primary Completion Date June 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • At least 18 years of age.
  • Postmenopausal as confirmed in medical history
  • Ability to understand the purposes and risks of the study and has signed a written informed consent form approved by the investigator's IRB (Institutional Review Board)/Ethics Committee.
  • Estrogen receptor positive breast cancer. Body mass index of 30 or greater.
  • Consented for tissue collection on CTRC (Cancer Therapy and Research Center) repository 07-32

Exclusion Criteria:

  • Cachexia
  • Active systemic illness (infection including viral illnesses such as Hepatitis and HIV)
  • Chronic use of NSAIDs (nonsteroidal anti-inflammatory drugs) aspirin or omega-3 free fatty acid supplementation within the last 60 days (defined as greater than or equal to 7 consecutive days)
  • Any NSAIDs aspirin 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Epp Goodwin 210-450-5798 ctrcreferral@uthscsa.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02538484
Other Study ID Numbers  ICMJE CTMS# 15-2100
HSC20150602H ( Other Identifier: UT Health Science Center Institutional Review Board )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party The University of Texas Health Science Center at San Antonio
Original Responsible Party Andrew Brenner, The University of Texas Health Science Center at San Antonio, Principal Investigator
Current Study Sponsor  ICMJE The University of Texas Health Science Center at San Antonio
Original Study Sponsor  ICMJE Andrew Brenner
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Andrew Brenner, MD, PhD Principal Investigator
PRS Account The University of Texas Health Science Center at San Antonio
Verification Date August 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP