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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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00416715
First received: December 27, 2006
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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


Condition Intervention Phase
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
 Drug: letrozole
Dietary Supplement: calcium carbonate
Other: laboratory biomarker analysis
Dietary Supplement: calcium citrate
Dietary Supplement: calcium glucarate
Drug: calcium gluconate
Dietary Supplement: cholecalciferol
Procedure: assessment of therapy complications
Procedure: musculoskeletal complications management/prevention
 Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Pilot Study of Vitamin D Deficiency and Myalgias, Arthralgias and/or Joint Stiffness Associated With Letrozole (Femara® )

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Rate of vitamin D deficiency in early breast cancer patients prescribed adjuvant letrozole who experience myalgias, arthralgias and/or joint stiffness [ Time Frame: Baseline and weekly for 4 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Relationship between letrozole serum levels and the development of myalgias, arthralgias and/or joint stiffness [ Time Frame: At week 4, intervention point, and 4-8 weeks after intervention point ] [ Designated as safety issue: No ]
  • Efficacy as assessed by rate and severity of myalgias, arthralgias, and/or joint stiffness [ Time Frame: At intervention point and 4 weeks after intervention point ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: October 2006
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
 Drug: letrozole
Given PO
Other Names:
  • CGS 20267
  • Femara
  • LTZ
Dietary Supplement: calcium carbonate
Given PO
Other Name: CaCO3
Other: laboratory biomarker analysis
Optional correlative studies
Dietary Supplement: calcium citrate
Given PO
Other Names:
  • Acicontral
  • CALCIT
  • Citracal
  • Tricalcium Citrate
Dietary Supplement: calcium glucarate
Given PO
Other Names:
  • antacidin
  • calcium D-glucarate
  • calcium D-saccharate
  • CGT
Drug: calcium gluconate
Given PO
Other Names:
  • Calcium D-gluconate
  • CALGLUC
  • Calglucon
Dietary Supplement: cholecalciferol
Given PO
Other Names:
  • Calciol
  • Vitamin D3
Procedure: assessment of therapy complications
Ancillary studies
Procedure: musculoskeletal complications management/prevention
Correlative studies
Other Names:
  • complications management/prevention, musculoskeletal
  • management/prevention, musculoskeletal complications

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00416715

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
Principal Investigator: Hannah Linden Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00416715     History of Changes
Other Study ID Numbers: 6346, NCI-2010-00621
Study First Received: December 27, 2006
Last Updated: May 7, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Arthralgia
Breast Neoplasms
Vitamin D Deficiency
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
 Calcium, Dietary
Cholecalciferol
Vitamin D
Ergocalciferols
Calcium Carbonate
Vitamins
Citric Acid
Letrozole
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions
Antacids
Molecular Mechanisms of Pharmacological Action
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 21, 2013