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

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Keywords

Abstract

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.

Dates

Last Verified:	09/30/2015
First Submitted:	03/07/2013
Estimated Enrollment Submitted:	03/10/2013
First Posted:	03/11/2013
Last Update Submitted:	10/19/2015
Last Update Posted:	10/20/2015
Actual Study Start Date:	09/30/2013
Estimated Primary Completion Date:	07/31/2015
Estimated Study Completion Date:	07/31/2015

Condition or disease

Breast Cancer

Musculoskeletal Disease

Intervention/treatment

Drug: vitamin D3

Drug: Placebo

Phase

Phase 2/Phase 3

Arm Groups

Arm	Intervention/treatment
Experimental: vitamin D3 1000 mg Ca2+/800IU vitamin D3 daily + 25 000IU vitamin D3 weekly during 6 months	Drug: vitamin D3 ampoule
Placebo Comparator: Placebo 1000 mg Ca2+/ 800IU vitamin D3 daily + 25000IU placebo every week during 6 months	Drug: Placebo ampoule

Eligibility Criteria

Ages Eligible for Study	18 Years To 18 Years
Sexes Eligible for Study	Female
Accepts Healthy Volunteers	Yes
Criteria	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

Outcome

Primary Outcome Measures

1. Change from baseline in musculoskeletal pain and 250HD levels [3 monthly during one year]

Secondary Outcome Measures

1. 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]

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

Keywords

breast neoplasms

neoplasms

bone resorption

myalgia

arthralgia