Clinical trial · Interventional
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
NCT02538484CI-TRIAL-00068035completedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Assess the impact of dietary omega 3 free fatty acids and/or letrozole on obese, postmenopausal breast cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fish Oil | Dietary Supplement | — | UNRESOLVED |
| Letrozole | Drug | Letrozole | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Letrozole
- description
- Letrozole 2.5 mg by mouth daily for 30 days.
- interventionNames
- Drug: Letrozole
- type
- ACTIVE_COMPARATOR
- label
- Fish Oil
- description
- Fish oil 2700 mg by mouth daily for 30 days.
- interventionNames
- Dietary Supplement: Fish Oil
- type
- ACTIVE_COMPARATOR
- label
- Letrozole and Fish Oil
- description
- Letrozole 2.5 mg and Fish oil 2700 mg by mouth daily for 30 days.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.