Effect of Vitamin D and Calcium Supplementation on Letrozole-induced Musculoskeletal Side Effects in Breast Cancer Egyptian Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Osteocalcin level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed breast cancer patients.
- •Postmenopausal hormone receptor positive.
- •Patients receiving letrozole for more than two months
- •Gender: Female.
- •Age: ≥ 50 years old.
排除标准
- •Patients with bone metastasis.
- •History of renal stones.
- •Serum calcium >11mg/L.
- •Patients with renal insufficiency.
- •Patients taking steroid hormone replacement therapy.
- •Second Malignancy.
研究组 & 干预措施
Control Group
20 patients will receive Letrozole only for 12 weeks.
干预措施: Letrozole 2.5mg (Drug)
VitD/Ca group
20 patients will receive Letrozole in addition to 2000 IU vitamin D3 and 1000 mg of calcium per day for 12 weeks.
干预措施: Letrozole + vitamin D3 and calcium (Drug)
结局指标
主要结局
Osteocalcin level
时间窗: 12 weeks
Osteocalcin level at base line and 12 weeks
次要结局
未报告次要终点
研究者
Mai Abo Elyazeed Hassan Hamouda
Clinical Pharmacist
Tanta University