Advanced Malignant Solid Neoplasm, Delirium, Hematopoietic and Lymphatic System Neoplasm, Insomnia
Conditions
Brief summary
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.
Detailed description
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: I. To collect preliminary data to investigate the hypotheses that use of suvorexant in addition to standard of care for hospitalized adults with cancer will result in a decreased incidence of delirium, increased time to onset of delirium, and decreased number of delirium days in hospital as compared to standard of care alone. II. To build a data collection and analysis infrastructure for a full scale RCT at Mayo Clinic if feasibility is demonstrated. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive suvorexant orally (PO) once daily (QD) at bedtime and standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity. ARM II: Patients receive standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.
Interventions
OTHERBest Practice
Receive standard of care
OTHERElectronic Health Record Review
Ancillary studies
OTHERInterview
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
DRUGSuvorexant
Given PO
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment | Up to 1 year | Feasibility will be defined as the ability to recruit 14 patients to the study with 20% or less study attrition. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to standard of care | Baseline (enrollment), assessed 3-7 days while in the hospital or until discharged, whichever comes first | Adherence to standard of care will be compared within each arm and between arms. Will be monitored with adequate adherence being defined as at 5/7 patients in each group and a between-group difference of no more than 2. |
| Change in Insomnia Severity Index score | Baseline (enrollment), assessed 3-7 days while in the hospital or until discharged, whichever comes first | Reduction of at least two points will be defined as clinical improvement. The Insomnia Severity Index consists of 7 items related to current (i.e., last 2 weeks0 severity of insomnia problems. Three items are rated on a scale of 0-4 where 0=none; 1=mild; 2=moderate; 3=severe; and 4=very severe. The remaining items are answered on similar scales of 0-4 (e.g., 0=not at all; 1=a little; 2=somewhat; 3=much; 4=very much). |
Countries
United States
Outcome results
None listed