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 current disease. The aromatase inhibitors (AI) have become a critical
component of adjuvant therapy for this population, but they cause bone pain, joint pain,
joint stiffness, and muscle weakness in approximately 40% of patients. These symptoms,
referred to as aromatase inhibitor-associated musculoskeletal symptoms (AIMSS), decrease
quality of life and medication adherence. Identifying effective ways to decrease these
symptoms may allow for longer and more adherent medication use and thus may improve
disease-free survival. We hypothesize that vitamin D3 may decrease symptoms associated with
the use of aromatase inhibitors.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Musculoskeletal symptoms on the BCPT symptom scale
Change from baseline to 6 months
No
Alice C. Shapiro, PhD RD
Principal Investigator
Park Nicollet Health Services
United States: Institutional Review Board
03962-10C
NCT01509079
March 2012
September 2014
Name | Location |
---|---|
Park Nicollet Frauenshuh Cancer Center | Minneapolis, Minnesota 55416 |