Clinical Study Evaluating the Role of Vitamin D Supplement in Patients With Colorectal Cancer Receiving Chemotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- The change in the serum concentrations of the measured biological markers
研究概览
简要总结
The aim of this work is to assess the of role of Vitamin D supplement on tumor response, inflammation and apoptosis in patients with stage II or III colorectal cancer receiving chemotherapy using BAX protein and Tumor necrosis factor - alpha (TNF- α) both are measured at baseline and after 6 months.
详细描述
This randomized, controlled parallel study will be conducted on 44 patients with Stage II or III colorectal cancer. Patients will be recruited from Clinical Oncology
Department, Menoufia university Hospital, Menoufia, Egypt. The patients will be randomized using sealed envelope method into the following two groups:
Group I (Control group; n=22) which will receive FOLFOX (leucovorin, fluorouracil, and oxaliplatin) or XELOX (capecitabine and oxaliplatin).
Group II: (Vitamin D group; n=22) which will receive the same chemotherapy regimen plus Vitamin D for 6 months.
Markers to be measured:
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
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with histologically and radiologically confirmed diagnosis of stage II or III colorectal cancer.
- •Performance status 0-1 according to the Eastern Cooperative Oncology Group (ECOG).
- •Patients who received FOLFOX or XELOX as first line chemotherapy.
- •Both genders.
- •Patients with adequate hematologic parameters (white blood cell count ≥3000/mm3, granulocytes ≥1500/mm3, platelets ≥100,000/mm3, hemoglobin ≥ 8 gm/l).
- •Patients with normal renal functions.
- •Patients with normal hepatic functions.
- •Patients with sufficient 25(OH) Vitamin D level (30-100 ng/mL).
排除标准
- •Patients with metastatic colorectal cancer (CRC).
- •Patients with parathyroid disorders.
- •Patients who are taking vitamin D-containing supplements (>800 IU/day) unless they discontinued vitamin D supplementation at least 2 months prior to enrollment.
- •Patients had a history of hypercalcemia.
研究组 & 干预措施
Vitamin D group
(Vitamin D group; n=22) which will receive the same chemotherapy regimen plus Vitamin D for 6 months.
干预措施: Vitamin D (Drug)
结局指标
主要结局
The change in the serum concentrations of the measured biological markers
时间窗: 6 months
* BAX protein as a marker for apoptosis * Tumor necrosis factor - alpha (TNF- α) as a marker of inflammation
次要结局
未报告次要终点
研究者
Menna Allah Ayman Aboelenean
Clinical pharmacist, principal investigator
Tanta University