Status:
COMPLETED
Vitamin D Deficiency, Muscle Pain, Joint Pain, and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer
Lead Sponsor:
University of Washington
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Arthralgia
Musculoskeletal Complications
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
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 d...
Detailed Description
PRIMARY OBJECTIVES: 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 trea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00416715
Start Date
October 1 2006
End Date
May 1 2010
Last Update
July 11 2017
Active Locations (1)
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1
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109