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


Phase 2
18 Years
N/A
Not Enrolling
Female
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

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Rate of vitamin D deficiency in early breast cancer patients prescribed adjuvant letrozole who experience myalgias, arthralgias and/or joint stiffness

Outcome Description:

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.

Outcome Time Frame:

Baseline and weekly for 4 weeks

Safety Issue:

No

Principal Investigator

Hannah Linden

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Authority:

United States: Institutional Review Board

Study ID:

6346

NCT ID:

NCT00416715

Start Date:

October 2006

Completion Date:

Related Keywords:

  • 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
  • Arthralgia
  • Breast Neoplasms
  • Vitamin D Deficiency

Name

Location

Fred Hutchinson Cancer Research Center/University of Washington Cancer ConsortiumSeattle, Washington  98109