search
Back to results

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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Letrozole
Fish Oil
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Houston Methodist Cancer Center at Texas Medical Center
  • Mays Cancer Center, UT Health San Antonio

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Letrozole

Fish Oil

Letrozole and Fish Oil

Arm Description

Letrozole 2.5 mg by mouth daily for 30 days.

Fish oil 2700 mg by mouth daily for 30 days.

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

Outcomes

Primary Outcome Measures

Change in levels of aromatase target gene.
Change in serum levels of PGE2 (prostaglandin E2).

Secondary Outcome Measures

Full Information

First Posted
August 11, 2015
Last Updated
July 13, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
search

1. Study Identification

Unique Protocol Identification Number
NCT02538484
Brief Title
Impact of Omega 3 Fatty Acid Supplementation on Aromatase in Obese Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
April 2016 (undefined)
Primary Completion Date
March 11, 2020 (Actual)
Study Completion Date
March 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Letrozole
Arm Type
Active Comparator
Arm Description
Letrozole 2.5 mg by mouth daily for 30 days.
Arm Title
Fish Oil
Arm Type
Active Comparator
Arm Description
Fish oil 2700 mg by mouth daily for 30 days.
Arm Title
Letrozole and Fish Oil
Arm Type
Active Comparator
Arm Description
Letrozole 2.5 mg and Fish oil 2700 mg by mouth daily for 30 days.
Intervention Type
Drug
Intervention Name(s)
Letrozole
Other Intervention Name(s)
Femara
Intervention Description
Aromatase inhibitor
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish Oil
Other Intervention Name(s)
Omega-3
Intervention Description
Omega-3 free fatty acid
Primary Outcome Measure Information:
Title
Change in levels of aromatase target gene.
Time Frame
30 Days
Title
Change in serum levels of PGE2 (prostaglandin E2).
Time Frame
30 Days

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Brenner, MD, PhD
Organizational Affiliation
Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Houston Methodist Cancer Center at Texas Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Mays Cancer Center, UT Health San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs