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

Early Phase 1

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Letrozole; Dietary Supplement: Fish Oil

• Registration Number: NCT02538484
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

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 Timeline

• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2015-08-31
• Study First Posted: 2015-09-02
• Study Start: 2016-04
• Primary Completion: 2020-03-11
• Study Completion: 2020-03-26
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-13
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Letrozole and Fish Oil	Fish Oil	Letrozole 2.5 mg and Fish oil 2700 mg by mouth daily for 30 days.
Fish Oil	Fish Oil	Fish oil 2700 mg by mouth daily for 30 days.
Letrozole	Letrozole	Letrozole 2.5 mg by mouth daily for 30 days.
Letrozole and Fish Oil	Letrozole	Letrozole 2.5 mg and Fish oil 2700 mg by mouth daily for 30 days.

Primary Outcome Measures

Name	Time	Method
Change in levels of aromatase target gene.	30 Days
Change in serum levels of PGE2 (prostaglandin E2).	30 Days

Trial Locations

Locations (2)

Mays Cancer Center, UT Health San Antonio; 🇺🇸 San Antonio, Texas, United States

Houston Methodist Cancer Center at Texas Medical Center; 🇺🇸 Houston, Texas, United States