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
Who is this study for? Adult female patients with breast cancer
What treatments are being studied? Fish Oil
Status: Completed
Location: See all (2) locations...
Intervention Type: Drug, Dietary supplement
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY
Assess the impact of dietary omega 3 free fatty acids and/or letrozole on obese, postmenopausal breast cancer patients.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Texas
Houston Methodist Cancer Center at Texas Medical Center
Houston
Mays Cancer Center, UT Health San Antonio
San Antonio
Time Frame
Start Date: 2016-04
Completion Date: 2020-03-26
Participants
Target number of participants: 24
Treatments
Active_comparator: Letrozole
Letrozole 2.5 mg by mouth daily for 30 days.
Active_comparator: Fish Oil
Fish oil 2700 mg by mouth daily for 30 days.
Active_comparator: Letrozole and Fish Oil
Letrozole 2.5 mg and Fish oil 2700 mg by mouth daily for 30 days.
Authors
Andew Brenner, Polly A Niravath
Related Therapeutic Areas
Sponsors
Leads: The University of Texas Health Science Center at San Antonio