Suvorexant for Delirium Prevention in Cancer Patients

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mayo Clinic

Must not be taking: CYP3A4 modulators, Benzodiazepines

Disqualifiers: Pregnancy, Delirium, Narcolepsy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 3-7 days

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. ^{1 2 3 4 5}

Is 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. ^{1 2 3 4 5}

How 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. ^{1 2 3 4 6}

Research Team

Regina M. Mackey, MD

Principal Investigator

Mayo Clinic in Rochester

Eligibility 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

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

Anticipated hospital course of at least 3 days post randomization as judged by the patient's primary inpatient team

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Patients receive suvorexant and standard of care for hospital associated insomnia for 3-7 days

3-7 days

Daily visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Suvorexant

Trial Overview 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.

Participant Groups

Group I: Arm I (suvorexant, standard of care) Experimental Treatment 5 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 Control 4 Interventions

Patients receive standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Findings from Research

In a study of nine cancer patients with delirium and insomnia, the use of suvorexant significantly reduced the severity of delirium symptoms, as measured by the DRS-R98 scale (from 10 to 6.66, p=0.0031).

Suvorexant was found to be safe, with no harmful effects reported, suggesting it could be a beneficial treatment option for managing delirium in hospitalized cancer patients experiencing sleep disturbances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Usefulness of Suvorexant for Complicated Delirium in Cancer Patients Who Experience Sleep Disturbance during Hospitalization]. Kessoku, T., Kusakabe, A., Matsuura, T., et al.[2019]

Suvorexant, administered at doses of 15 to 20 mg, effectively reduces the incidence and onset time of delirium in acutely hospitalized patients, potentially leading to shorter hospital stays.

The treatment was well tolerated, with adverse effects comparable to those of a placebo, indicating a favorable safety profile for suvorexant in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of suvorexant in the prevention of delirium during acute hospitalization: A systematic review. Adams, AD., Pepin, MJ., Brown, JN.[2021]

In a study of 1,255 ICU patients, suvorexant significantly reduced the incidence of delirium when administered at any time before delirium onset, showing an unadjusted hazard ratio of 0.16, indicating a strong protective effect.

However, when analyzing patients who received suvorexant within 72 hours of admission, the protective effect diminished and lost statistical significance after adjusting for confounding factors, suggesting that timing of administration is crucial for efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing the effect of immortal time bias affects the analysis of prevention of delirium by suvorexant in critically ill patients: A retrospective cohort study. Shiotsuka, J., Uchino, S., Sasabuchi, Y., et al.[2023]

In a study of 70 critically ill patients in the ICU, those treated with suvorexant experienced a significantly longer time to onset of delirium compared to those receiving conventional treatment, suggesting its potential effectiveness in preventing delirium.

The study indicates that suvorexant could be a promising option for preventing delirium in ICU patients, as it was administered over a 7-day period with no significant differences in demographic or clinical characteristics between the groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ability of suvorexant to prevent delirium in patients in the intensive care unit: a randomized controlled trial. Azuma, K., Takaesu, Y., Soeda, H., et al.[2022]

A meta-analysis of seven studies involving 402 patients treated with suvorexant showed a significant reduction in the incidence of delirium (odds ratio of 0.30) and a delay in the onset of delirium (standardized mean difference of 0.44) compared to control treatments.

Suvorexant did not show significant benefits on secondary outcomes such as length of hospital stay, time on ventilation, or mortality, indicating its primary effectiveness lies in preventing delirium rather than improving overall hospital metrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suvorexant for the prevention of delirium: A meta-analysis. Xu, S., Cui, Y., Shen, J., et al.[2021]

Suvorexant, both alone and in combination with ramelteon, significantly reduces the incidence of delirium in hospitalized adults, based on a meta-analysis of 2594 patients across various studies.

When benzodiazepines are used, the combination of suvorexant and ramelteon is particularly effective in preventing delirium, while suvorexant alone does not show significant benefits in this context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Suvorexant with or without ramelteon to prevent delirium: a systematic review and meta-analysis. Tian, Y., Qin, Z., Han, Y.[2022]

References

1. Japan pubmed.ncbi.nlm.nih.gov

[Usefulness of Suvorexant for Complicated Delirium in Cancer Patients Who Experience Sleep Disturbance during Hospitalization]. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

The role of suvorexant in the prevention of delirium during acute hospitalization: A systematic review. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

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]

4. United States pubmed.ncbi.nlm.nih.gov

Ability of suvorexant to prevent delirium in patients in the intensive care unit: a randomized controlled trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Suvorexant for the prevention of delirium: A meta-analysis. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Suvorexant with or without ramelteon to prevent delirium: a systematic review and meta-analysis. [2022]