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临床试验/NCT04488237
NCT04488237Unknown不适用

Effect of Vitamin D Administration on Methotrexate Adverse Effects in Patients With Acute Lymphoblastic Leukemia

Assiut University0 个研究点目标入组 50 人开始时间: 2020年9月最近更新:
适应症
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试验速览

阶段
不适用
入组人数
50
主要终点
Effect of vitamin D administration on methotrexate adverse effects in patients with acute lymphoblastic leukemia

研究概览

简要总结

Since methotrexate toxicity represents a major problem in patients treating with cancer and there are few studies about the role of vitamin D in the pathogenesis of this toxicity, so the aim of the present study is investigation of the effect of vitamin D administration on methotrexate toxicity such as oral ulcerations, bone marrow toxicity as well as renal and hepatic toxicity also the role of inflammatory mediators and oxidative stress markers in methotrexate toxicity will be evaluated, taking in consideration the dose of leucovorin rescue.

详细描述

Leukemia is a type of blood cancer that affects the body's white blood cells (WBCs). White blood cells help fight infection and protect the body against disease, but in leukemia, some of the white blood cells turn cancerous and don't work as they should. As more cancerous cells form in the blood and bone marrow (spongy tissue inside the bones), there's less room for healthy cells .

The different types of leukemia can be either acute (fast growing) or chronic (slow growing). Acute lymphoblastic leukemia (ALL) happens when the body makes too many lymphoblasts (a type of white blood cell). It's the most common type of childhood cancer.

Treatment outcome of acute leukemia has been improved recently using Methotrexate . Side effects of methotrexate usually in the form of ulcerative stomatitis, leukopenia (lower amount of white blood cells), nausea, abdominal discomfort, and elevated liver and kidney function tests. Identifying risk factors leading to these side effects would be valuable to develop preventive interventions and improve quality of life for these young patients.

Studies revealed a relationship between vitamin D deficiency and adverse reactions of chemotherapy in cancer patients. This vitamin is important in many physiological processes in the body as bone mineralization and immune regulations . A human body produces vitamin D as a response to sun exposure. A person can also boost their vitamin D intake through certain foods or supplements. .

Previous literature showed that receptors for vitamin D expressed in the mucosa and so there is a relationship between vitamin D deficiency and increase inflammation and impairment of mucosa .

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
1 Year 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients with acute lymphoblastic leukemia who do not start treatment course with methotrexate.
  • Both sex will be included.
  • Age group (1 -12 years)

排除标准

  • Patients with other type of cancer beside ALL.
  • Patients with renal, hepatic or hematological diseases.

结局指标

主要结局

Effect of vitamin D administration on methotrexate adverse effects in patients with acute lymphoblastic leukemia

时间窗: 1 to 2 years according to the availability of the cases

Since methotrexate toxicity represents a major problem in patients treating with cancer and there are few studies about the role of vitamin D in the pathogenesis of this toxicity, so the aim of the present study is investigation of the effect of vitamin D administration on methotrexate toxicity such as oral ulcerations, bone marrow toxicity as well as renal and hepatic toxicity also the role of inflammatory mediators and oxidative stress markers in methotrexate toxicity will be evaluated, taking in consideration the dose of leucovorin rescue.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Magy Ibrahim Anis Rizkallah

Demonstrator of cancer biology

Assiut University

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