Trials / Completed
CompletedNCT02538484
Impact of Omega 3 Fatty Acid Supplementation on Aromatase in Obese Subjects
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
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- The University of Texas Health Science Center at San Antonio · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Letrozole | Aromatase inhibitor |
| DIETARY_SUPPLEMENT | Fish Oil | Omega-3 free fatty acid |
Timeline
- Start date
- 2016-04-01
- Primary completion
- 2020-03-11
- Completion
- 2020-03-26
- First posted
- 2015-09-02
- Last updated
- 2023-07-17
Locations
2 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02538484. Inclusion in this directory is not an endorsement.