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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

Study Description
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Brief Summary:
Assess the impact of dietary omega 3 free fatty acids and/or letrozole on obese, postmenopausal breast cancer patients.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Letrozole Dietary Supplement: Fish Oil Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: 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
Study Start Date : April 2016
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Letrozole
Letrozole 2.5 mg by mouth daily for 30 days.
 Drug: Letrozole
Aromatase inhibitor
Other Name: Femara
Active Comparator: Fish Oil
Fish oil 2700 mg by mouth daily for 30 days.
 Dietary Supplement: Fish Oil
Omega-3 free fatty acid
Other Name: Omega-3
Active Comparator: Letrozole and Fish Oil
Letrozole 2.5 mg and Fish oil 2700 mg by mouth daily for 30 days.
 Drug: Letrozole
Aromatase inhibitor
Other Name: Femara

Dietary Supplement: Fish Oil
Omega-3 free fatty acid
Other Name: Omega-3


Outcome Measures
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Primary Outcome Measures :
  1. Change in levels of aromatase target gene. [ Time Frame: 30 Days ]
  2. Change in serum levels of PGE2 (prostaglandin E2). [ Time Frame: 30 Days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT02538484


Contacts
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Contact: Epp Goodwin 210-450-5798 ctrcreferral@uthscsa.edu

Locations
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United States, Texas
Houston Methodist Cancer Center at Texas Medical Center Active, not recruiting
Houston, Texas, United States, 77030
Mays Cancer Center, UT Health San Antonio Recruiting
San Antonio, Texas, United States, 78229
Contact: Epp Goodwin       CTRCReferral@uthscsa.edu   
Principal Investigator: Andew Brenner, MD         
Sponsors and Collaborators
The University of Texas Health Science Center at San Antonio
Investigators
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Principal Investigator: Andrew Brenner, MD, PhD Principal Investigator
More Information
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Responsible Party: The University of Texas Health Science Center at San Antonio
ClinicalTrials.gov Identifier: NCT02538484    
Other Study ID Numbers: CTMS# 15-2100
HSC20150602H ( Other Identifier: UT Health Science Center Institutional Review Board )
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: August 29, 2022
Last Verified: August 2022
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
 Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs