Suvorexant for Delirium Prevention in Cancer Patients
Recruiting in Palo Alto (17 mi)
Overseen ByRegina M. Mackey, MD
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Mayo Clinic
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial requires that you stop using any benzodiazepines, benzodiazepine receptor modulators, or first-generation antihistamines at least 72 hours before joining. Also, you cannot use strong or moderate CYP3A4 inducers and inhibitors during the trial.
What data supports the effectiveness of the drug Suvorexant for preventing delirium in cancer patients?
Research shows that Suvorexant helped reduce delirium symptoms in cancer patients with sleep problems, as their delirium severity scores significantly decreased after taking the drug. Additionally, a meta-analysis suggests that Suvorexant, known for treating insomnia, may also help prevent delirium, although more consensus is needed.
12345Is suvorexant safe for use in humans?
Suvorexant has been studied for its safety in preventing delirium in hospitalized patients, including those with cancer, and has not shown any harmful effects in these studies.
12345How does the drug suvorexant differ from other treatments for preventing delirium in cancer patients?
Suvorexant is unique because it is primarily used as a sleep aid and works by blocking orexin receptors, which are involved in wakefulness. This mechanism may help prevent delirium, especially in cancer patients who experience sleep disturbances, making it different from other treatments that do not target sleep-related pathways.
12346Eligibility Criteria
This trial is for hospitalized cancer patients experiencing insomnia, which may lead to delirium. Participants should meet the study's inclusion criteria and not have any conditions that would exclude them from participating as per the trial's exclusion criteria.Inclusion Criteria
I have advanced cancer and suffer from insomnia despite trying non-drug treatments.
Exclusion Criteria
I have been diagnosed with a sleep disorder like sleep apnea.
I am not taking any strong medications like certain antifungals or seizure drugs.
I have a history of lung disease, but not asthma.
I am unable to give consent for medical procedures.
I have experienced confusion or delirium during my current hospital stay.
I have a history of cirrhosis.
Participant Groups
The trial compares suvorexant combined with standard care versus standard care alone in treating insomnia and preventing delirium in hospitalized cancer patients. Suvorexant is a medication that blocks brain substances causing wakefulness.
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm I (suvorexant, standard of care)Experimental Treatment5 Interventions
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.
Group II: Arm II (standard of care)Active Control4 Interventions
Patients receive standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
References
[Usefulness of Suvorexant for Complicated Delirium in Cancer Patients Who Experience Sleep Disturbance during Hospitalization]. [2019]We investigated the usefulness of suvorexant for complicated delirium in patients with cancer who experience sleep disturbance during hospitalization. Nine patients with malignant tumors complicated with symptoms of delirium and insomnia were included in this study; their palliative care was managed by the palliative care team of our hospital for a period of one year from April 2016 to March 2017. A retrospective follow-up study was then conducted. The Japanese version of DRS-R98 was used to evaluate the severity of the patient's delirium. The total severity score of DRS-R98 significantly decreased after the administration of suvorexant when compared to the score before its administration(6.66±1.73 vs 10±3.20, p=0.0031). In addition, suvorexant did not exhibit any harmful effects. Our results indicate that suvorexant was useful in alleviating delirium symptoms in cancer patients who experience sleep disturbance.
The role of suvorexant in the prevention of delirium during acute hospitalization: A systematic review. [2021]To assess the efficacy and safety of suvorexant for the prevention of delirium during acute hospitalization.
Reducing the effect of immortal time bias affects the analysis of prevention of delirium by suvorexant in critically ill patients: A retrospective cohort study. [2023]Studies assessing the effect of suvorexant on delirium prevention included patients treated before development of delirium, which can introduce immortal time bias. The objective of the present study was to evaluate the effect of suvorexant on delirium, comparing patients treated before the onset of delirium with patients treated within 72h of admission using the same dataset.
Ability of suvorexant to prevent delirium in patients in the intensive care unit: a randomized controlled trial. [2022]There are no effective, tolerable, and established medications for preventing delirium in critically ill patients admitted to the intensive care unit (ICU). We investigated whether suvorexant was effective in preventing ICU delirium.
Suvorexant for the prevention of delirium: A meta-analysis. [2021]Delirium is a frequently encountered complication, which is associated with increased mortality. Suvorexant, an approved agent for the treatment of insomnia, is recently suggested to be also effective for prevention of delirium by some authors. However, a consensus has yet to be reached. The goal of this study was to perform a meta-analysis to overall estimate the effectiveness of suvorexant in preventing delirium and its related consequences.
Suvorexant with or without ramelteon to prevent delirium: a systematic review and meta-analysis. [2022]Delirium is a common and serious neurobehavioral syndrome, associated with prolonged hospital stays, and increased morbidity and mortality. As it remains unclear whether suvorexant with or without ramelteon prevents delirium in elderly hospitalized patients, we conducted a systematic review and meta-analysis to evaluate, searching the PubMed, Cochrane Library, Web of Science, EMBASE, and EBSCOhost databases for all randomized controlled trials (RCTs), case-control studies, and cohort studies that investigated the effects of suvorexant with or without ramelteon on delirium in adult hospitalized patients. The primary outcome was the incidence of delirium. Two randomized controlled trials, 7 cohort studies and 2 case-control studies involving 2594 patients were included in this meta-analysis. The results showed that both suvorexant alone (odds ratio (OR) = 0.30, 95% confidence interval (CI): 0.14-0.65, P = 0.002) and suvorexant with ramelteon (OR = 0.39, 95% CI 0.23-0.65, P = 0.0003) reduced the incidence of delirium in adult hospitalized patients. Six studies involved the use of benzodiazepines; subgroup analysis performed separately in the suvorexant alone and suvorexant with ramelteon groups indicated that when benzodiazepine was administered, suvorexant with ramelteon was effective at reducing the incidence of delirium (OR = 0.53, 95% CI 0.37-0.74, P = 0.0002), but no significant difference was observed for suvorexant alone (OR = 0.40, 95% CI 0.11-1.53, P = 0.18). The current literature thus supports the effectiveness of suvorexant with or without ramelteon for delirium prevention, although suvorexant alone failed to significantly reduce the incidence of delirium when benzodiazepine was administered. The present study was limited by the significant heterogeneity among the included studies, and caution should be exercised when interpreting the results. This study was registered in the PROSPERO database (CRD4202017964).