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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02538484
• Other study ID #: CTMS# 15-2100
• Secondary ID: HSC20150602H
• Status: Completed
• Phase: Early Phase 1
• Start date: April 2016
• Est. completion date: March 26, 2020

Study information

• Verified date: July 2023
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 26, 2020
• Est. primary completion date: March 11, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Letrozole
Aromatase inhibitor

Dietary Supplement:
• Fish Oil
Omega-3 free fatty acid

Locations

Country	Name	City	State
United States	Houston Methodist Cancer Center at Texas Medical Center	Houston	Texas
United States	Mays Cancer Center, UT Health San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in levels of aromatase target gene.		30 Days
Primary	Change in serum levels of PGE2 (prostaglandin E2).		30 Days