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

Completed · Phase 2

Conditions studied: 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

In brief

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

Key facts

Study ID

NCT00416715

Run by

University of Washington

People needed

100

Starts

2006-10-01

Expected to finish

2010-05-01

Last updated by the study team

2017-07-11

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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