A Randomized Double Blinded Placebo Controlled Oral Selenium Therapy for the Prevention of Mucositis in Patients Undergoing High Dose Chemotherapy With Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 1 期
- 入组人数
- 76
- 试验地点
- 1
- 主要终点
- The grade of oral mucositis after bone marrow transplantation
研究概览
简要总结
Selenium as an antioxidant and anti-inflammatory agent could be effective in prevention of mucositis induced by chemotherapy and radiotherapy. Other agents such as vitamin E, Zinc sulfate, amifostine, beta carotene and benzidamine are indicated for prevention of mucositis and positive effects are seen. Our purpose in this double blinded randomized study is to evaluate the selenium effect on mucositis prevention in patient with acute myeloid leukemia (AML) & acute lymphoblastic leukemia (ALL) whose received Busulfan and/or Cyclophosphamide before Hematopoietic stem cell transplantation (HSCT).
详细描述
Patients with AML or ALL diagnosis, candidates for high dose chemotherapy with stem cell transplantation will be screened for enrollment in the study.
Patients will be randomized in two groups with balanced block randomization method. One group will receive selenium tablet twice per day and another group will receive placebo two times per day.Therapy will start on the morning before starting chemotherapy and will continue until the first of either discharge day or day +21.
Response assessment will include:
- Mucositis assessment using WHO grading and OMAS scores- to be done from baseline and until day +21 or discharge day if before day +21.
- Evaluation of selenium and glutathione peroxidase levels in the serum, - to be done at baseline, day +7 and day +14.
- Collection of clinical outcome data regarding infectious complications including- presence and length of febrile neutropenia, use of antibacterial and antifungal medications
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with AML or ALL undergoing high dose chemotherapy with stem cell transplantation
- •Adequate renal and hepatic function
排除标准
- •Taking selenium supplement before admission
研究组 & 干预措施
Experimental
Oral selenium therapy arm
干预措施: Oral selenium (Drug)
Placebo
Oral placebo
干预措施: Oral placebo (Drug)
结局指标
主要结局
The grade of oral mucositis after bone marrow transplantation
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 3 weeks
The effect of oral selenium on prevention of mucositis in patients undergoing bone marrow transplantation
次要结局
- Evaluation of selenium concentration and glutathione peroxidase level in serum(up to 3 weeks)
- Total days of mucositis after BMT(Participants will be followed for the duration of hospital stay, an expected average of 3 weeks)