Vitamin D and Calcium Supplementation in Breast Cancer

Phase 2

Recruiting

• Conditions: Breast Cancer
• Interventions: Drug: Letrozole 2.5mg; Drug: Letrozole + vitamin D3 and calcium

• Registration Number: NCT05523609
• Lead Sponsor: Tanta University

Brief Summary

This study aims at assessing the vitamin Dstatus in breast cancer patients who receive letrozole for more than two months and to evaluate effects of vitamin D3 and calcium supplementation on arthalgia caused by letrozole on these patients.

Detailed Description

Background: Vitamin D deficiency (\< 10 ng/mL) and insufficiency (10-30 ng/mL) may contribute to musculoskeletal symptoms observed in patients taking letrozole. This study was undertaken to assess the vitamin D status in breast cancer patients who received letrozole for \> 6 months and to evaluate the effects of vitamin D3 and calcium supplementation on them.

Methods: Forty breast cancer patients were included. They were divided into 2 equal groups: Control group received Letrozole only, and VitD/Ca group received Letrozole in addition to 2000 IU vitamin D3 and 1000 mg of calcium per day for 12 weeks. Baseline serum 25-hydroxy vitamin D concentrations were assayed and standard health assessment questionnaire was completed to assess the disability caused by musculoskeletal symptoms.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-08-25
• Study First Submitted QC: 2022-08-29
• Study First Posted: 2022-08-31
• Study Start: 2022-11-01
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-30
• Last Update Posted: 2023-12-01
• Primary Completion: 2024-09
• Study Completion: 2024-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Newly diagnosed breast cancer patients.
• Postmenopausal hormone receptor positive.
• Patients receiving letrozole for more than two months
• Gender: Female.
• Age: ≥ 50 years old.

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Exclusion Criteria

• Patients with bone metastasis.
• History of renal stones.
• Serum calcium >11mg/L.
• Patients with renal insufficiency.
• Patients taking steroid hormone replacement therapy.
• Second Malignancy.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Letrozole 2.5mg	20 patients will receive Letrozole only for 12 weeks.
VitD/Ca group	Letrozole + vitamin D3 and calcium	20 patients will receive Letrozole in addition to 2000 IU vitamin D3 and 1000 mg of calcium per day for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Osteocalcin level	12 weeks	Osteocalcin level at base line and 12 weeks

Trial Locations

Locations (1)

Tanta Cancer Center; 🇪🇬 Tanta, El-Gharbia, Egypt