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Clinical Trials/NCT02538484
NCT02538484CompletedEarly Phase 1

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

The University of Texas Health Science Center at San Antonio2 sites in 1 country24 target enrollmentStarted: April 2016Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Early Phase 1
Status
Completed
Enrollment
24
Locations
2
Primary Endpoint
Change in levels of aromatase target gene.

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

  • 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

Arms & Interventions

Letrozole

Active Comparator

Letrozole 2.5 mg by mouth daily for 30 days.

Intervention: Letrozole (Drug)

Fish Oil

Active Comparator

Fish oil 2700 mg by mouth daily for 30 days.

Intervention: Fish Oil (Dietary Supplement)

Letrozole and Fish Oil

Active Comparator

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

Intervention: Letrozole (Drug)

Letrozole and Fish Oil

Active Comparator

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

Intervention: Fish Oil (Dietary Supplement)

Outcomes

Primary Outcomes

Change in levels of aromatase target gene.

Time Frame: 30 Days

Change in serum levels of PGE2 (prostaglandin E2).

Time Frame: 30 Days

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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