Purpose

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

Condition

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)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Letrozole
Letrozole 2.5 mg by mouth daily for 30 days.
  • 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
Active Comparator
Letrozole and Fish Oil
Letrozole 2.5 mg and Fish oil 2700 mg by mouth daily for 30 days.
  • Drug: Letrozole
    Aromatase inhibitor
    Other names:
    • Femara
  • Dietary Supplement: Fish Oil
    Omega-3 free fatty acid
    Other names:
    • Omega-3

Recruiting Locations

Mays Cancer Center, UT Health San Antonio
San Antonio, Texas 78229
Contact:
Epp Goodwin
CTRCReferral@uthscsa.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center at San Antonio

Study Contact

Epp Goodwin
210-450-5798
ctrcreferral@uthscsa.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.