Vitamin D Deficiency, Muscle Pain, Joint Pain, and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer

• Status: Completed
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: Female

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 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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Washington
• Collaborator: National Cancer Institute (NCI)
• Treatments: Calcium; Calcium Carbonate; Calcium, Dietary; Cholecalciferol; Citric Acid; Ergocalciferols; Letrozole; Sodium Citrate; Vitamin D; Vitamins

Criteria

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