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Vitamin D3 for Aromatase Inhibitor Induced Arthralgias

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase II Prevention Active 18 and over Other 11548
NCT00867217

Trial Description

Summary

The primary purpose is to determine if high dose vitamin D3 reduces the incidence of musculoskeletal symptoms associated with the aromatase inhibitor letrozole in women with early stage breast cancer and low serum vitamin D levels. The primary hypothesis is that high dose vitamin D3 prevents the worsening of musculoskeletal symptoms when compared to a standard dose vitamin D3 treatment.

Further Study Information

This protocol will examine the relationship between vitamin D levels (25-hydroxyvitamin D) and various quality of life measures in women being treated with letrozole as standard care for early stage breast cancer.

Eligibility Criteria

Inclusion Criteria:

Post-menopausal women newly diagnosed with early stage breast cancer, who would be treated with an aromatase inhibitor

Serum 25OHD levels < 40 ng/ml

Exclusion Criteria:

Severe or debilitating musculoskeletal pain

Known metastatic disease

History of renal stones

History of hypercalcemia or hyperthyroidism

Currently receiving adjuvant or neoadjuvant chemotherapy

Currently receiving other investigational agents

Trial Contact Information

Trial Lead Organizations/Sponsors

Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center

Novartis Pharmaceuticals Corporation

BTR Group, Incorporated

Qamar J Khan, MD

Principal Investigator

Bruce F Kimler, PhD		Ph: 913-588-4523
		Email: bkimler@kumc.edu

Trial Sites

U.S.A.

Kansas

Westwood

University of Kansas Hospital - Westwood Campus

Bruce F Kimler, PhD Ph: 913-588-4523

Email: bkimler@kumc.edu

Wichita

Cancer Center of Kansas, PA - Wichita

Tracy Hartup, RN, BSN, OCN Ph: 316-613-4316

Email: tracy.hartup@cancercenterofkansas.com

Pavan S Reddy, MD Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00867217
Information obtained from ClinicalTrials.gov on April 26, 2009

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.