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

The University of Texas System (UT)

Status and phase: Completed; Early Phase 1

Conditions: Breast Cancer

Treatments: Drug: Letrozole; Dietary Supplement: Fish Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT02538484

HSC20150602H (Other Identifier)

CTMS# 15-2100

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 3 patient groups

Letrozole

Active Comparator group

Description:

Letrozole 2.5 mg by mouth daily for 30 days.

Treatment:

Drug: Letrozole

Fish Oil

Active Comparator group

Description:

Fish oil 2700 mg by mouth daily for 30 days.

Treatment:

Dietary Supplement: Fish Oil

Letrozole and Fish Oil

Active Comparator group

Description:

Letrozole 2.5 mg and Fish oil 2700 mg by mouth daily for 30 days.

Treatment:

Dietary Supplement: Fish Oil

Drug: Letrozole