Purpose

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

Category

IRB Number
20150602HU
NCT Number
NCT02538484
Open to Enrollment
Yes
Sponsor
The University of Texas Health Science Center at San Antonio -



Study Contact

Local Recruitment Point of Contact
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Principal Investigator
Andrew Brenner

Regulatory Point of Contact
Andrew Brenner
(210) 562-4091
brennera@uthscsa.edu

Regulatory Point of Contact
Frances Crawford
(210) 450-5037
crawfordf1@uthscsa.edu

Regulatory Point of Contact
Sonia Creighton
(210) 450-1366
creighton@uthscsa.edu

Regulatory Point of Contact
Heather King
heather.king@usoncology.com

Regulatory Point of Contact
Lori Nance
lori.nance@usoncology.com

Regulatory Point of Contact
Myrna Montenegro
(210) 450-5954
montenegro@uthscsa.edu

Regulatory Point of Contact
Mailbox Ctrc Regulatory Affairs
regaffapp@uthscsa.edu

Regulatory Point of Contact
Regulatory Staff
regaffstaff@uthscsa.edu

Regulatory Point of Contact
Kathleen Rodriguez
(210) 450-1365
rodriguezk3@uthscsa.edu

Regulatory Point of Contact
Ofelia Romero
(210) 450-1804
romeroo@uthscsa.edu

Regulatory Point of Contact
Benjamin Schleif
(210) 450-1366
schleifb@uthscsa.edu

Regulatory Point of Contact
Morgan Seekatz
(210) 450-1133
seekatz@uthscsa.edu



Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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

    • 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

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
None (Open Label)
Condition
  • Breast Cancer
  • Arm Groups

    ArmDescriptionIntervention
    Active Comparator

    Letrozole

    Letrozole 2.5 mg by mouth daily for 30 days.
  • Dietary Supplement: Fish Oil

    Omega-3 free fatty acid

    Other names:

    • Omega-3

  • Drug: Letrozole

    Aromatase inhibitor

    Other names:

    • Femara

  • Active Comparator

    Letrozole and Fish Oil

    Letrozole 2.5 mg and Fish oil 2700 mg by mouth daily for 30 days.
  • Dietary Supplement: Fish Oil

    Omega-3 free fatty acid

    Other names:

    • Omega-3

  • Drug: Letrozole

    Aromatase inhibitor

    Other names:

    • Femara

  • Active Comparator

    Fish Oil

    Fish oil 2700 mg by mouth daily for 30 days.
  • Dietary Supplement: Fish Oil

    Omega-3 free fatty acid

    Other names:

    • Omega-3

  • Drug: Letrozole

    Aromatase inhibitor

    Other names:

    • Femara