Vitamin D Deficiency, Muscle Pain, Joint Pain, and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer
NCT ID: NCT00416715
Last Updated: 2017-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2006-10-31
2010-05-31
Brief Summary
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Detailed Description
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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 treatment.
SECONDARY OBJECTIVES:
I. To determine if there is a correlation between letrozole serum levels and the development of myalgias, arthralgias and/or joint stiffness.
II. To assess if vitamin D supplementation may alleviate myalgias, arthralgias and/or joint stiffness associated with letrozole in those subjects with vitamin D deficiency.
OUTLINE:
Patients receive letrozole orally (PO) once daily (QD). Patients, who experience muscle pain, joint pain, or joint stiffness that requires an intervention and who are found to be vitamin D deficient, also receive calcium PO and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Treatment (letrozole)
Patients receive letrozole PO QD. Patients, who experience muscle pain, joint pain, or joint stiffness that requires an intervention and who are found to be vitamin D deficient, also receive calcium and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.
letrozole
Given PO
calcium carbonate
Given PO
laboratory biomarker analysis
Optional correlative studies
calcium citrate
Given PO
calcium glucarate
Given PO
calcium gluconate
Given PO
cholecalciferol
Given PO
assessment of therapy complications
Ancillary studies
musculoskeletal complications management/prevention
Correlative studies
Interventions
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letrozole
Given PO
calcium carbonate
Given PO
laboratory biomarker analysis
Optional correlative studies
calcium citrate
Given PO
calcium glucarate
Given PO
calcium gluconate
Given PO
cholecalciferol
Given PO
assessment of therapy complications
Ancillary studies
musculoskeletal complications management/prevention
Correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Washington
OTHER
Responsible Party
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Hannah Linden
Principal Investigator
Principal Investigators
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Hannah Linden
Role: PRINCIPAL_INVESTIGATOR
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Locations
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Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Other Identifiers
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NCI-2010-00621
Identifier Type: REGISTRY
Identifier Source: secondary_id
6346
Identifier Type: -
Identifier Source: org_study_id
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