Placebo-controlled Trial With Vitamin D to Prevent Worsening/Relieve Aromatase Inhibitor-induced Musculoskeletal Symptoms in Breast Cancer Patients

Phase 2

Terminated

• Conditions: Breast Cancer; Musculoskeletal Disease
• Interventions: Drug: Placebo; Drug: Vitamin D3

• Registration Number: NCT01809171
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

The third generation oral aromatase inhibitors (AIs) are increasingly being used in the management of estrogen receptor positive breast cancer. One of the issues related with administration of oral AIs is their side effects, particularly on the musculoskeletal system. Although the prevalence and importance of arthralgia and myalgia occurring in BC patients receiving adjuvant AIs are evident, the mechanisms clearly explaining these invalidating symptoms are unknown.

In this project, we aim to unravel the interaction between vitamin D and musculoskeletal adverse events experienced by AI users. We will also evaluate how vitamin D supplementation affects AI-induced musculoskeletal symptoms in breast cancer patients, by means of a randomized placebo-controlled double blind clinical trial. We will assess changes in the musculoskeletal system by using magnetic resonance imaging of joints, hand grip strength and also monitor serum IGF-I and estrogen levels together with bone resorption and formation markers.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-03-08
• Study First Submitted QC: 2013-03-11
• Study First Posted: 2013-03-12
• Study Start: 2013-10
• Primary Completion: 2015-08
• Study Completion: 2015-08
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-20
• Last Update Posted: 2015-10-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

• Postmenopausal status
• Currently being treated with an AI in the adjuvant setting (minimum for 8 weeks)
• AIMSS as determined by new or worsened musculoskeletal complaints following AI therapy
• Vitamin D deficiency (<30ng/ml)
• Caucasian

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Exclusion Criteria

• Hormone replacement therapy last 6 months
• Current use or in the last 12 months of bisphosphonates
• Tamoxifen use in last 6 months
• History of kidney stones
• History of hypercalcemia/hypercalciuria or hyperthyroidism
• Paget's disease of the bone
• Current use of Digitalis/digoxin or thiazide diuretics
• Current use of vitamin D (or multivitamin) supplementation should be stopped

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	1000 mg Ca2+/ 800IU vitamin D3 daily + 25000IU placebo every week during 6 months
vitamin D3	Vitamin D3	1000 mg Ca2+/800IU vitamin D3 daily + 25 000IU vitamin D3 weekly during 6 months

Primary Outcome Measures

Name	Time	Method
Change from baseline in musculoskeletal pain and 250HD levels	3 monthly during one year

Secondary Outcome Measures

Name	Time	Method
Change from baseline in bone parameters, estrogen and IGF-I levels and fluid accumulation and tendon pathologies, as seen on MRI	3 monthly during 1 year, MRI at baseline and 3 months

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium