Vitamin D3 for Aromatase Inhibitor Induced Arthralgias

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Dietary Supplement: High Dose Vitamin D; Dietary Supplement: Placebo; Dietary Supplement: Standard Dose Vitamin D3; Drug: Letrozole 2.5mg

• Registration Number: NCT00867217
• Lead Sponsor: Qamar Khan

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-20
• Study First Submitted QC: 2009-03-20
• Study First Posted: 2009-03-23
• Primary Completion: 2011-01
• Study Completion: 2011-01
• Results First Submitted: 2016-03-14
• Status Verified: 2018-01
• Results First Submitted QC: 2018-01-11
• Last Update Submitted: 2018-01-11
• Results First Posted: 2018-02-09
• Last Update Posted: 2018-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Dose Vitamin D	Standard Dose Vitamin D3	High Dose Vitamin D3 capsule (3 x 10,000 IU capsules weekly). All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily).
Placebo	Letrozole 2.5mg	Placebo matched for High Dose Vitamin D3 capsules. All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily).
High Dose Vitamin D	Letrozole 2.5mg	High Dose Vitamin D3 capsule (3 x 10,000 IU capsules weekly). All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily).
Placebo	Standard Dose Vitamin D3	Placebo matched for High Dose Vitamin D3 capsules. All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily).
High Dose Vitamin D	High Dose Vitamin D	High Dose Vitamin D3 capsule (3 x 10,000 IU capsules weekly). All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily).
Placebo	Placebo	Placebo matched for High Dose Vitamin D3 capsules. All subjects also received standard dose vitamin D3 (600 IU daily) and letrozole (2.5 mg daily).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Worsening of Musculoskeletal Symptoms (MS)	Change from Baseline to 24 Weeks	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.

Trial Locations

Locations (2)

Cancer Centers of Kansas, P.A.; 🇺🇸 Wichita, Kansas, United States

University of Kansas Medical Center; 🇺🇸 Westwood, Kansas, United States