Vitamin D and Calcium Supplementation in Breast Cancer

Breast Cancer Clinical Trial

Official title:

Effect of Vitamin D and Calcium Supplementation on Letrozole-induced Musculoskeletal Side Effects in Breast Cancer Egyptian Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05523609
• Other study ID #: Vitamin D and breast cancer
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: November 1, 2022
• Est. completion date: October 2024

Study information

• Verified date: November 2023
• Source: Tanta University
• Contact: Mai A Elgebaly, Pharm D
• Phone: 01061412257
• Email: dr.mai.elgebaly[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Letrozole 2.5mg
20 patients will receive Letrozole only for 12 weeks
• Letrozole + vitamin D3 and calcium
20 patients will receive Letrozole in addition to 2000 IU vitamin D3 per day for 12 weeks.

Locations

Country	Name	City	State
Egypt	Tanta Cancer Center	Tanta	El-Gharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Osteocalcin level	Osteocalcin level at base line and 12 weeks	12 weeks