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

Pain Clinical Trial

Official title:

A Pilot Study of Vitamin D Deficiency and Myalgias, Arthralgias and/or Joint Stiffness Associated With Letrozole (Femara® )

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. 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

Related Conditions & MeSH terms

• Arthralgia
• Breast Neoplasms
• 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
• Vitamin D Deficiency

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