Clinical trial NCT01809171: Placebo-controlled Trial With Vitamin D to Prevent Worsening/Relieve Aromatase Inhibitor-induced Musculoskeletal Symptoms in Breast Cancer Patients
Official title: Placebo-controlled Trial With Vitamin D to Prevent Worsening/Relieve Aromatase Inhibitor-induced Musculoskeletal Symptoms in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Breast Cancer
Musculoskeletal Disease
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2013-03-12
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change from baseline in musculoskeletal pain and 250HD levels
timeFrame: 3 monthly during one year
Secondary outcomes:
measure: Change from baseline in bone parameters, estrogen and IGF-I levels and fluid accumulation and tendon pathologies, as seen on MRI
timeFrame: 3 monthly during 1 year, MRI at baseline and 3 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
Study officials:
References:
citation: Roberts KE, Adsett IT, Rickett K, Conroy SM, Chatfield MD, Woodward NE. Systemic therapies for preventing or treating aromatase inhibitor-induced musculoskeletal symptoms in early breast cancer. Cochrane Database Syst Rev. 2022 Jan 10;1(1):CD013167. doi: 10.1002/14651858.CD013167.pub2.