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Changes in Breast Cancer Biomarkers Using Synergistic Prostaglandin Inhibitors

NCT01425476 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2017-08-09

No results posted yet for this study

Summary

This is a biomarker study with the goal of measuring changes in proteins and gene methylation. This study is not intended for use in diagnosing, mitigating, treating, curing, or preventing disease.

The purpose of this study is to determine if Vitamin D (cholecalciferol) alone and in combination with celecoxib (Celebrex, a non-steroidal anti-inflammatory drug, or NSAID), to decrease breast cancer risk by their effect on certain biological indicators (biomarkers) of breast cancer risk (called PGE2, COX-2, and 15-PGDH) and cell changes in the breast.

Conditions

Interventions

DRUG

Celecoxib

Take one tablet from each bottle (one bottle containing either placebo/celecoxib and one bottle containing either cholecalciferol 400 IU or 2,000 IU) daily for 30 days.

DRUG

Placebo

Take one tablet from each bottle (one bottle containing either placebo/celecoxib and one bottle containing either cholecalciferol 400 IU or 2,000 IU) daily for 30 days.

DRUG

Cholecalciferol

Take one tablet from each bottle (one bottle containing either placebo/celecoxib and one bottle containing either cholecalciferol 400 IU or 2,000 IU) daily for 30 days.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • University of North Dakota

    collaborator OTHER

  • Hartford Hospital

    lead OTHER

Principal Investigators

  • Edward Sauter, MD, PhD · University of North Dakota

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • United States

Study Locations

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Entities

Drugs
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 NCT01425476 on ClinicalTrials.gov