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

NCT01809171 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2015-10-21

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Vitamin D3

ampoule

DRUG

Placebo

ampoule

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Belgium

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01809171 on ClinicalTrials.gov