Status:
COMPLETED
Vitamin D3 Effects on Musculoskeletal Symptoms With Use of Aromatase Inhibitors
Lead Sponsor:
HealthPartners Institute
Collaborating Sponsors:
University of Minnesota
University of Southern California
Conditions:
Muscle Pain
Joint Pain
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The Purpose of this study is to determine whether vitamin D3 supplements will decrease the muscle and bone pain that are reported by women who take Aromatase Inhibitors.
Detailed Description
This project will determine the efficacy of vitamin D3 supplements for reducing side effects of treatment with aromatase inhibitors in women with a history of breast cancer that have no evidence of cu...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Women with a history of stage I-IIIa invasive breast cancer
- History of hormone-receptor positive cancer (either ER + or PR + or both)
- Are prescribed and are taking anastrozole, letrozole or exemestane for at least one month and have at least 7 months of AI treatment remaining
- Are experiencing AIMSS
Exclusion
- Unable to read or understand English
- History of psychiatric disability affecting informed consent or compliance with drug intake
- Malabsorption syndrome or inability to take oral medication
- Has less than 7 months of AI therapy remaining
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT01509079
Start Date
March 1 2012
End Date
March 1 2015
Last Update
June 18 2019
Active Locations (1)
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1
Park Nicollet Frauenshuh Cancer Center
Minneapolis, Minnesota, United States, 55416