Feasibility of Prophylactic Haldol to Prevent Delirium in Cancer Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 主要终点
- Side Effects and Tolerability of Haldol in Patients With Undergoing Hematopoietic Stem Cell Transplant
研究概览
简要总结
This research study proposes to conduct an open label, feasibility study administering prophylactic oral haldol to patients undergoing a hematopoietic stem cell transplant (HSCT).
The study will address the following research aims: 1) To demonstrate the feasibility of enrolling HSCT patients in a prophylactic medication trial, 2) To determine the tolerability of oral haldol in HSCT patients and 2) To compare rates of delirium in HSCT patients who receive prophylactic haldol with an untreated historical control group.
详细描述
This is an open label, safety & feasibility, clinical drug trial. We will use historical controls from previous research with bone marrow transplant patients and delirium incidence at University of Iowa Hospitals and Clinics (UIHC) to evaluate the efficacy of prophylactic Haldol in the prevention of delirium. This study will recruit adult cancer patients undergoing hematopoietic stem cell transplant (HSCT) at UIHC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant must undergo an autologous or allogeneic bone marrow or stem cell transplant
- •The participant is 18 years of age or older
- •The participant provides written consent
排除标准
- •The participant has a QTc of >450 msec at the time of enrollment
- •The participant used any antipsychotic medications within the last 30 days
- •The participant has any significant allergies or past intolerance to Haloperidol
- •The participant has a history of major neurological, metabolic, psychiatric, or cardiovascular disease, cerebrovascular event, or substance abuse
- •The participant has a history of mental retardation or learning disability that, at the discretion of the investigator, could affect their ability to complete study assessments.
研究组 & 干预措施
Oral Haldol in patients undergoing HSCT
Prior to stem cell transplant participants will receive 5mg of liquid or pill form, oral Haldol. Every other day visits will take place following the first administration of the study drug until 14 days after the transplant.
干预措施: Haldol (Drug)
结局指标
主要结局
Side Effects and Tolerability of Haldol in Patients With Undergoing Hematopoietic Stem Cell Transplant
时间窗: Daily, up to 14 days following transplant
Categorize and quantify adverse events from start of drug (day 1) to end of study drug per (CTCAE) version 4.0
次要结局
未报告次要终点
研究者
Michelle Weckmann
Clinical Assistant Professor
University of Iowa