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