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

NCT ID: NCT01809171

Last Updated: 2015-10-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2015-08-31

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.

Conditions

Breast Cancer; Musculoskeletal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

vitamin D3

1000 mg Ca2+/800IU vitamin D3 daily + 25 000IU vitamin D3 weekly during 6 months

Group Type: EXPERIMENTAL

Vitamin D3

Intervention Type: DRUG

ampoule

Placebo

1000 mg Ca2+/ 800IU vitamin D3 daily + 25000IU placebo every week during 6 months

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

ampoule

Interventions

Vitamin D3

ampoule

Intervention Type: DRUG

Placebo

ampoule

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospitals Leuven

Leuven, , Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 35005781 (View on PubMed)

Other Identifiers

2013-001064-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

s55283

Identifier Type: -

Identifier Source: org_study_id