A Pilot Randomized, Open Label Trial of Orexin Receptor Antagonist for Insomnia in Hospitalized Patients With Cancer to Prevent Delirium
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- Mayo Clinic
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Recruitment
研究概览
简要总结
This phase IV trial compares suvorexant with standard of care to standard of care alone for improving difficulty sleeping (insomnia) and reducing confusion (delirium) in hospitalized cancer patients. Delirium can lengthen hospitalization, increase the delay of cancer treatment and can even increase the risk of premature death. Suvorexant is in a class of medications called orexin receptor antagonists. It works by blocking the action of a certain natural substance in the brain that causes wakefulness. Giving suvorexant with standard of care to treat insomnia may be more effective compared to standard of care alone in reducing the development of delirium in hospitalized cancer patients.
详细描述
PRIMARY OBJECTIVE:
I. Feasibility of a subsequent full scale randomized clinical trial (RCT) conducted at Mayo Clinic using the same methodology as outlined in this protocol (as this study is a pilot).
SECONDARY OBJECTIVE:
I. To generate preliminary data to determine if inpatient standard of care (i.e. sleep enhancement) is followed in both a study arm receiving standard of care alone and one receiving standard of care plus suvorexant.
EXPLORATORY OBJECTIVES:
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
- 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
- •Presence of advanced active malignancy and insomnia despite nonpharmacologic management
- •Anticipated hospital course of at least 3 days post randomization as judged by the patient's primary inpatient team
- •One or more of the following risk factors of delirium:
- •Age 75 or above
- •Hearing impairment
- •Vision impairment
- •Initiation of 8 or new medications since start of hospitalization
- •Chronic kidney disease III or greater
- •Congestive heart failure
- •Hospitalization for 14 or more days
- •Dehydration requiring ongoing use of intravenous (IV) hydration
- •Electrolyte imbalance requiring ongoing correction
排除标准
- •Inability to consent
- •Current pregnancy
- •Women of childbearing potential (defined as women under age 55 without a personal history of surgical or chemotherapy-induced sterility)
- •Current or prior delirium in the active hospitalization
- •Concurrent use of strong/moderate CYP3A4 inducers and inhibitors (including but not limited to -azole antifungals, amiodarone, phenytoin, carbamazepine, etc.)
- •Use of any benzodiazepine, benzodiazepine receptor modulator, or first generation antihistamine class medication within 72 hours prior to enrollment
- •Personal history of narcolepsy
- •Personal history of other primary sleep disorders including obstructive sleep apnea
- •Personal history of alcohol use disorder
- •Personal history of substance use disorder
- •Personal history of cirrhosis
- •Transaminitis more than 3 times the upper limit of normal
- •History of obstructive lung disease other than asthma
研究组 & 干预措施
Arm I (suvorexant, standard of care)
Patients receive suvorexant PO QD at bedtime and standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.
干预措施: Best Practice (Other)
Arm I (suvorexant, standard of care)
Patients receive suvorexant PO QD at bedtime and standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.
干预措施: Electronic Health Record Review (Other)
Arm I (suvorexant, standard of care)
Patients receive suvorexant PO QD at bedtime and standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.
干预措施: Interview (Other)
Arm I (suvorexant, standard of care)
Patients receive suvorexant PO QD at bedtime and standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Arm I (suvorexant, standard of care)
Patients receive suvorexant PO QD at bedtime and standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.
干预措施: Suvorexant (Drug)
Arm II (standard of care)
Patients receive standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.
干预措施: Best Practice (Other)
Arm II (standard of care)
Patients receive standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.
干预措施: Electronic Health Record Review (Other)
Arm II (standard of care)
Patients receive standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.
干预措施: Interview (Other)
Arm II (standard of care)
Patients receive standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Recruitment
时间窗: Up to 1 year
Feasibility will be defined as the ability to recruit 14 patients to the study with 20% or less study attrition.
次要结局
- Adherence to standard of care(Baseline (enrollment), assessed 3-7 days while in the hospital or until discharged, whichever comes first)
- Change in Insomnia Severity Index score(Baseline (enrollment), assessed 3-7 days while in the hospital or until discharged, whichever comes first)