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NCT00723398 · ClinicalTrials.gov registry record · NA
Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention
A NA study, sponsored by Milton S. Hershey Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 266
- Enrollment target
NCT00723398 is a NA study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 266 participants.
The verdict
NCT00723398, a NA study, has completed, sponsored by Milton S. Hershey Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 266 participants
- Enrollment target
Study Summary
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.
Interventions
- DIETARY_SUPPLEMENT Lovaza 4gm oral
- DRUG Raloxifene 60 Mg Oral Tablet
- DRUG Raloxifene 30 Mg Oral Tablet
- DRUG Lovaza 4gm & Raloxifene 30mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 266 participants |
| Start Date | 2009-03 |
| Est. Completion | 2015-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00723398
The ClinicalTrials.gov registry entry for NCT00723398 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 266 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Milton S. Hershey Medical Center, which has 396 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Lovaza 4gm oral is the first listed.
NCT00723398 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00723398 about?
NCT00723398 is a clinical study titled "Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention". 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 p...
What is the current status of trial NCT00723398?
This trial is currently completed. It is a NA study. The enrollment target is 266 participants. The study started on 2009-03. Estimated completion is 2015-04.
What interventions are being tested in trial NCT00723398?
The interventions under investigation include: Lovaza 4gm oral (DIETARY_SUPPLEMENT), Raloxifene 60 Mg Oral Tablet (DRUG), Raloxifene 30 Mg Oral Tablet (DRUG), Lovaza 4gm & Raloxifene 30mg (DRUG).
Who is sponsoring clinical trial NCT00723398?
This trial is sponsored by Milton S. Hershey Medical Center, which has 396 total clinical trials registered on ClinicalTrials.gov.
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