Vitamin D3 for Aromatase Inhibitor Induced Arthralgias

Qamar Khan160 enrolled

Overview

The primary purpose is to determine if high dose vitamin D3 reduces the incidence of musculoskeletal symptoms associated with the aromatase inhibitor letrozole in women with early stage breast cancer and low serum vitamin D levels.

The primary hypothesis is that high dose vitamin D3 plus standard dose vitamin D3 prevents the worsening of musculoskeletal symptoms when compared to a standard dose vitamin D3 treatment. This protocol will examine the relationship between vitamin D levels (25-hydroxyvitamin D) and various quality of life measures in women being treated with letrozole as standard care for early stage breast cancer. All subjects received letrozole and a standard dose of vitamin D3 (600 IU daily). Randomization was between high dose vitamin D3 (30,000 IU once per week) vs. a blinded, matched placebo,

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

160

Conditions

Breast Cancer

Interventions

High Dose Vitamin DDIETARY_SUPPLEMENT

High Dose Vitamin D3 (3 capsules of 10,000 IU) weekly for 24 weeks.

PlaceboDIETARY_SUPPLEMENT

Placebo comparator

Standard Dose Vitamin D3DIETARY_SUPPLEMENT

Standard Dose Vitamin D3 (600 IU of vitamin D3 daily)

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Post-menopausal women newly diagnosed with early stage breast cancer, who would be treated with an aromatase inhibitor * Serum 25OHD levels \< 40 ng/ml Exclusion Criteria: * Severe or debilitating musculoskeletal pain * Known metastatic disease * History of renal stones * History of hypercalcemia or hyperthyroidism * Currently receiving adjuvant or neoadjuvant chemotherapy * Currently receiving other investigational agents

Locations (2)

University of Kansas Medical Center

Westwood, Kansas, United States

Cancer Centers of Kansas, P.A.

Wichita, Kansas, United States

Outcomes

Primary Outcomes

Number of Participants With Worsening of Musculoskeletal Symptoms (MS)

Worsening of Musculoskeletal Symptoms (MS) is defined as any one of the following three events: (a) an increase by at least 0.25 in the Health Assessment Questionnaire II (HAQ II, a measure of disability from joint pain) score, (b) an increase in patient reported severity of joint and/or muscle pain, or (c) discontinuation from trial prior to 24 weeks specifically because of problems with musculoskeletal symptoms.

Time frame: Change from Baseline to 24 Weeks

Data from ClinicalTrials.gov

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