Vitamin D and Calcium Supplementation in Breast Cancer

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Letrozole 2.5mg
* Drug: Letrozole + vitamin D3 and calcium


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control Group<br>20 patients will receive Letrozole only for 12 weeks. | Drug: Letrozole 2.5mg<br>* 20 patients will receive Letrozole only for 12 weeks<br>|
| Experimental: VitD/Ca group<br>20 patients will receive Letrozole in addition to 2000 IU vitamin D3 and 1000 mg of calcium per day for 12 weeks. | Drug: Letrozole + vitamin D3 and calcium<br>* 20 patients will receive Letrozole in addition to 2000 IU vitamin D3 per day for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Osteocalcin level | Osteocalcin level at base line and 12 weeks | 12 weeks |