Phase 2
N=100
Vitamin D Deficiency, Muscle Pain, Joint Pain, and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer
Arthralgia · Musculoskeletal Complications · Pain · Recurrent Breast Cancer · Stage I Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00416715 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jul 2017
Primary outcome: Primary: Number of Early Breast Cancer Patients Prescribed Adjuvant Letrozole That Are Vitamin D Deficient and Who Experience Myalgias, Arthralgias and/or Joint Stiffness — 12; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- letrozole (Drug); calcium carbonate (Dietary_supplement); laboratory biomarker analysis (Other); calcium citrate (Dietary_supplement); calcium glucarate (Dietary_supplement); calcium gluconate (Drug); cholecalciferol (Dietary_supplement); assessment of therapy complications (Procedure); musculoskeletal complications management/prevention (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Washington
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Early Breast Cancer Patients Prescribed Adjuvant Letrozole That Are Vitamin D Deficient and Who Experience Myalgias, Arthralgias and/or Joint Stiffness |
12; 1 | — |
| SECONDARY Letrozole Serum Levels Before and After Vitamin D Repletion |
85; 70 | — |
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
Data sourced from ClinicalTrials.gov (NCT00416715). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.