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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01809171
• Other study ID #: s55283
• Secondary ID: 2013-001064-27
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: March 8, 2013
• Last updated: October 20, 2015
• Start date: October 2013
• Est. completion date: August 2015

Study information

• Verified date: October 2015
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 15
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Musculoskeletal Disease
• Musculoskeletal Diseases

Intervention

Drug:
• Vitamin D3
ampoule
• Placebo
ampoule

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in musculoskeletal pain and 250HD levels		3 monthly during one year	No
Secondary	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	No