Pain Clinical Trial
Official title:
A Pilot Study of Vitamin D Deficiency and Myalgias, Arthralgias and/or Joint Stiffness Associated With Letrozole (Femara® )
Verified date | May 2013 |
Source | University of Washington |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
This phase II trial is studying vitamin D deficiency, muscle pain, joint pain, and joint stiffness in postmenopausal women receiving letrozole for stage I-III breast cancer. Learning about vitamin D deficiency and muscle pain, joint pain, and joint stiffness in patients receiving letrozole for breast cancer may help doctors plan treatment and may help patients live more comfortably
Status | Completed |
Enrollment | 100 |
Est. completion date | |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients must have a histologically confirmed diagnosis of Stage I, II or III breast carcinoma - Patients must be prescribed letrozole for adjuvant breast cancer treatment - Prior adjuvant tamoxifen is permitted - Patients must be postmenopausal; for study purposes, postmenopausal is defined as: a prior documented bilateral oophorectomy, or a history of at least 12 months without spontaneous menstrual bleeding, or have a persistently postmenopausal estradiol in the past 6 months without menses, and clinically in menopause at the judgment of the treating physician, or age 60 or older with a prior hysterectomy without oophorectomy, or age less than 60 with a prior hysterectomy without oophorectomy (or in whom the status of the ovaries is unknown), with a documented FSH level demonstrating confirmatory elevation in the postmenopausal range for the lab Exclusion Criteria: - Diagnosis of Stage IV breast carcinoma - Pre-existing myalgias, arthralgias and/or joint stiffness >= Grade 1, as defined using CTEP CTC identified during baseline physical exam - Inability to understand or cooperate with study procedures - Receipt of investigational drug within 30 days before study entry - Lack of physical integrity of the upper gastrointestinal tract or malabsorption syndrome - Unwillingness to give informed consent - Unwillingness to participate or inability to comply with the protocol for the duration of the study - Patients with serum calcium >= 14 mg/dL - Patients with renal dysfunction defined as glomerular filtration rate <10ml/min calculated using Cockroft-Gault equation |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
University of Washington | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Relationship between letrozole serum levels and the development of myalgias, arthralgias and/or joint stiffness | At week 4, intervention point, and 4-8 weeks after intervention point | No | |
Secondary | Efficacy as assessed by rate and severity of myalgias, arthralgias, and/or joint stiffness | At intervention point and 4 weeks after intervention point | No |
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