Vitamin D Deficiency, Muscle Pain, Joint Pain, and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer
Condition: Arthralgia; Musculoskeletal Complications; Pain; Recurrent Breast Cancer; Stage I Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer
MeSH terms: Breast Neoplasms; Arthralgia; Vitamin D Deficiency
Intervention: letrozole; calcium carbonate; laboratory biomarker analysis; calcium citrate; calcium glucarate; calcium gluconate; cholecalciferol; assessment of therapy complications; musculoskeletal complications management/prevention
Intervention description: Given PO; Given PO; Optional correlative studies; Given PO; Given PO; Given PO; Given PO; Ancillary studies; Correlative studies
Intervention MeSH terms: Calcium, Dietary; Vitamin D; Cholecalciferol; Letrozole; Calcium Carbonate; Citric Acid; Sodium Citrate; Calcium
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

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
    

Eligibility 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