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Nutritional Supplements and Hormonal Manipulations for Breast Cancer Prevention

NCT00723398 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 266

Last updated 2018-11-01

Study results available
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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.

Conditions

Interventions

DIETARY_SUPPLEMENT

Lovaza 4gm oral

Dietary supplement; Take 4 mg oral capsules daily

DRUG

Raloxifene 60 Mg Oral Tablet

60 mg orally every day for two years

DRUG

Raloxifene 30 Mg Oral Tablet

30 mg orally daily for two years

DRUG

Lovaza 4gm & Raloxifene 30mg

Lovaza 4gm and Raloxifene 30 Mg orally once per day for 2 years

Sponsors & Collaborators

  • Milton S. Hershey Medical Center

    lead OTHER

Principal Investigators

  • Andrea Manni, MD · Penn State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00723398 on ClinicalTrials.gov