A Randomized Double Blind Placebo Controlled Clinical Trial Aim to Assess the Efficacy of Vitamin E Formulation (Tocopherol) in the Treatment of Chemotherapy Induced Stomatitis in Patients Undergoing Stem Cell Transplantation
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- To evaluate the tolerability and the safety of a Tocopherol formulation in the prevention or suppression of the serverity of oral mucositis induced by myeloablative agonist.
研究概览
简要总结
The present protocol is an attempt to prevent/treat mucositis in highly susceptible patients subjected to maximally tolerated doses of subsequently-myeloablative or myeloablative doses of chemoradiotherapy supported by autologous or allogeneic stem cell transplantation at the Department of Bone Marrow Transplantation. Mucositis is a major problem in the management of transplant recipients which subjects the patients to the risk of sepsis, need for parenteral nutrition and need of narcotics. We are planning a 2 arm study, comparing 2 safe vitamin E based formulations with placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and non-pregnant and non-lactating females, 18 years of age or older at the time of screening, who are to receive myeloablative agonists with or without total body irradiation (TBI) in preparation for either allogeneic or autologous HSCT. Patients who are to be hospitalized and are expected to remain hospitalized until marrow recovery.
- •Karnofsky performance status of 60 or greater or ECOG performance status of 2 or less.
- •Normal dental examination as assessed by the investigator.
排除标准
- •Clinically significant acute and active oral cavity infection.
- •Patients taking any investigational or other non-approved oral therapy for oral mucositis.
- •Known hypersensitivity to Vitamin E.
结局指标
主要结局
To evaluate the tolerability and the safety of a Tocopherol formulation in the prevention or suppression of the serverity of oral mucositis induced by myeloablative agonist.
次要结局
- To evaluate the toxicity and the safety of a Tocopherol formulation in the prevention or suppression of the serverity of oral mucositis induced by myeloablative agonist.