Clinical trial · Interventional
Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention
Combination of Low Dose Antiestrogens With Omega-3 Fatty Acids for Prevention of Hormone-independent Breast Cancer
- 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)
The overall hypothesis is that the combination of a low dose of the antiestrogen Raloxifene with omega-3 fatty acids will exert a synergistic breast cancer chemopreventive effect due to the crosstalk of their downstream cellular effects leading to decreased proliferation and increased apoptosis of premalignant mammary cells. Based on the investigators hypothesis that upregulation of functional estrogen receptors in the premalignant lesions is also responsible for the development of hormone independent tumors, the investigators postulate that the combination of antiestrogens and omega-3 fatty acids will reduce the development of both hormone-dependent and -independent tumors. At present, there are no known interventions able to decrease the development of hormone-independent tumors, which are more prevalent, more aggressive, leading to the patient's demise. In addition, the investigators postulate that this approach will be safe since it will combine a lower and hence a less toxic dose of Raloxifene with the administration of omega-3 fatty acids which are known to have health benefits, i.e., reduction in cardiovascular risk, beyond their possible chemo preventive effect in breast cancer.
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 (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lovaza 4gm oral | Dietary Supplement | — | UNRESOLVED |
| Lovaza 4gm & Raloxifene 30mg | Drug | — | UNRESOLVED |
| Raloxifene 30 Mg Oral Tablet | Drug | — | UNRESOLVED |
| Raloxifene 60 Mg Oral Tablet | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- NO_INTERVENTION
- label
- Group 1: Control
- description
- Control, no intervention
- type
- EXPERIMENTAL
- label
- Group 2: Raloxifene 60 Mg Oral Tablet
- description
- Raloxifene 60 mg Orally Daily
- interventionNames
- Drug: Raloxifene 60 Mg Oral Tablet
- type
- EXPERIMENTAL
- label
- Group 3: Raloxifene 30 Mg Oral Tablet
- description
- Raloxifene 30 mg Orally Daily
- interventionNames
- Drug: Raloxifene 30 Mg Oral Tablet
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Postmenopausal status defined as history of at least 12 months without spontaneous menstrual bleeding or a documented hysterectomy and bilateral salpingo oophorectomy * Breast density greater than 25% * No hormone replacement therapy for at least six months prior to entry into this study * Non-smokers. Exclusion Criteria: * History of stroke, pulmonary embolism or deep vein thrombosis * History of atherosclerotic heart disease * Presence of any known hypercoagulable state either congenital (e.g., protein S deficiency) or acquired (e.g., corticosteroid treatment) * Diabetes mellitus * Uncontrolled hypertension (BP ≥140/90) * Presence of a psychiatric condition that would interfere with adherence to the protocol.
References
Publications (1)
- DERIVEDManni A, Richie JP, Schetter SE, Calcagnotto A, Trushin N, Aliaga C, El-Bayoumy K. Stearoyl-CoA desaturase-1, a novel target of omega-3 fatty acids for reducing breast cancer risk in obese postmenopausal women. Eur J Clin Nutr. 2017 Jun;71(6):762-765. doi: 10.1038/ejcn.2016.273. Epub 2017 Feb 1. PMID 28145413