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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: Completed NA study, sponsored by Milton S. Hershey Medical Center.
NCT00723398 is a NA study that has completed, run by Milton S. Hershey Medical Center. The registered enrollment target is 266 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change of absolute breast density as indicated by mammography from baseline to Year +1 and completion of study (Year +2). No other mammograms will be obtained or used for the purpose of this study. Absolute breast density volume is based on breast thickness and the x-ray attenuation at each pixel of the image.
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 |
What the finished NCT00723398 record still lists
NCT00723398 is an interventional study that assigns participants to a tested intervention. The registered 266 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 4 interventions - of which Lovaza 4gm oral is the first listed.
NCT00723398 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00723398's enrollment target sits among peer trials
266 395th of 2000 higher than 1,606 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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