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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00416715
Other study ID # 6346
Secondary ID NCI-2010-00621
Status Completed
Phase Phase 2
First received December 27, 2006
Last updated May 7, 2013
Start date October 2006

Study information

Verified date May 2013
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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


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 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.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Intervention

Drug:
letrozole
Given PO
Dietary Supplement:
calcium carbonate
Given PO
Other:
laboratory biomarker analysis
Optional correlative studies
Dietary Supplement:
calcium citrate
Given PO
calcium glucarate
Given PO
Drug:
calcium gluconate
Given PO
Dietary Supplement:
cholecalciferol
Given PO
Procedure:
assessment of therapy complications
Ancillary studies
musculoskeletal complications management/prevention
Correlative studies

Locations

Country Name City State
United States Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
University of Washington National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Rate of vitamin D deficiency in early breast cancer patients prescribed adjuvant letrozole who experience myalgias, arthralgias and/or joint stiffness The rate and severity of myalgias, arthralgias and/or joint stiffness 4 weeks after the intervention will be described, and compared to the rate and severity at the intervention point using logistic regression and ordinal regression. Baseline and weekly for 4 weeks No
Secondary Relationship between letrozole serum levels and the development of myalgias, arthralgias and/or joint stiffness At week 4, intervention point, and 4-8 weeks after intervention point No
Secondary Efficacy as assessed by rate and severity of myalgias, arthralgias, and/or joint stiffness At intervention point and 4 weeks after intervention point No
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