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

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02538484

Enrollment

Registered

2015-09-02

Start date

2016-04-30

Completion date

2020-03-26

Last updated

2023-07-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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.

Interventions

DRUGLetrozole

Aromatase inhibitor

DIETARY_SUPPLEMENTFish Oil

Omega-3 free fatty acid

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026