A Pilot Study of Vitamin D Deficiency and Myalgias, Arthralgias and/or Joint Stiffness Associated With Letrozole (Femara® )
I. To assess the rate of vitamin D deficiency in breast cancer patients who experience
myalgias, arthralgias and/or joint stiffness following initiation of adjuvant letrozole
I. To determine if there is a correlation between letrozole serum levels and the development
of myalgias, arthralgias and/or joint stiffness.
II. To assess if vitamin D supplementation may alleviate myalgias, arthralgias and/or joint
stiffness associated with letrozole in those subjects with vitamin D deficiency.
Patients receive letrozole orally (PO) once daily (QD). Patients, who experience muscle
pain, joint pain, or joint stiffness that requires an intervention and who are found to be
vitamin D deficient, also receive calcium PO and vitamin D3 PO. Treatment continues for up
to 28 weeks in the absence of disease progression or unacceptable toxicity.
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Rate of vitamin D deficiency in early breast cancer patients prescribed adjuvant letrozole who experience myalgias, arthralgias and/or joint stiffness
The rate and severity of myalgias, arthralgias and/or joint stiffness 4 weeks after the intervention will be described, and compared to the rate and severity at the intervention point using logistic regression and ordinal regression.
Baseline and weekly for 4 weeks
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|