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

Primary Purpose

Arthralgia, Musculoskeletal Complications, Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
letrozole
calcium carbonate
laboratory biomarker analysis
calcium citrate
calcium glucarate
calcium gluconate
cholecalciferol
assessment of therapy complications
musculoskeletal complications management/prevention
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Arthralgia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (letrozole)

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Early Breast Cancer Patients Prescribed Adjuvant Letrozole That Are Vitamin D Deficient and Who Experience Myalgias, Arthralgias and/or Joint Stiffness
Count of early breast cancer patients prescribed adjuvant letrozole that are vitamin D deficient and who experience myalgias, arthralgias and/or joint stiffness, assessed at baseline and 1 month after vitamin D repletion.

Secondary Outcome Measures

Letrozole Serum Levels Before and After Vitamin D Repletion
Letrezole serum level concentration in patients that were vitamin D deficient and experienced myalgias, arthralgias and/or joint stiffness.

Full Information

First Posted
December 27, 2006
Last Updated
June 10, 2017
Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00416715
Brief Title
Vitamin D Deficiency, Muscle Pain, Joint Pain, and Joint Stiffness in Postmenopausal Women Receiving Letrozole For Stage I-III Breast Cancer
Official Title
A Pilot Study of Vitamin D Deficiency and Myalgias, Arthralgias and/or Joint Stiffness Associated With Letrozole (Femara® )
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (letrozole)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
letrozole
Other Intervention Name(s)
CGS 20267, Femara, LTZ
Intervention Description
Given PO
Intervention Type
Dietary Supplement
Intervention Name(s)
calcium carbonate
Other Intervention Name(s)
CaCO3
Intervention Description
Given PO
Intervention Type
Other
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Optional correlative studies
Intervention Type
Dietary Supplement
Intervention Name(s)
calcium citrate
Other Intervention Name(s)
Acicontral, CALCIT, Citracal, Tricalcium Citrate
Intervention Description
Given PO
Intervention Type
Dietary Supplement
Intervention Name(s)
calcium glucarate
Other Intervention Name(s)
antacidin, calcium D-glucarate, calcium D-saccharate, CGT
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
calcium gluconate
Other Intervention Name(s)
Calcium D-gluconate, CALGLUC, Calglucon
Intervention Description
Given PO
Intervention Type
Dietary Supplement
Intervention Name(s)
cholecalciferol
Other Intervention Name(s)
Calciol, Vitamin D3
Intervention Description
Given PO
Intervention Type
Procedure
Intervention Name(s)
assessment of therapy complications
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
musculoskeletal complications management/prevention
Other Intervention Name(s)
complications management/prevention, musculoskeletal, management/prevention, musculoskeletal complications
Intervention Description
Correlative studies
Primary Outcome Measure Information:
Title
Number of Early Breast Cancer Patients Prescribed Adjuvant Letrozole That Are Vitamin D Deficient and Who Experience Myalgias, Arthralgias and/or Joint Stiffness
Description
Count of early breast cancer patients prescribed adjuvant letrozole that are vitamin D deficient and who experience myalgias, arthralgias and/or joint stiffness, assessed at baseline and 1 month after vitamin D repletion.
Time Frame
Baseline and 1 month post vitamin D repletion
Secondary Outcome Measure Information:
Title
Letrozole Serum Levels Before and After Vitamin D Repletion
Description
Letrezole serum level concentration in patients that were vitamin D deficient and experienced myalgias, arthralgias and/or joint stiffness.
Time Frame
Baseline and 1 month post vitamin D repletion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hannah Linden
Organizational Affiliation
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

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

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