Advanced Malignant Solid NeoplasmPhase 4NCT06834386
Suvorexant for Insomnia to Prevent Delirium in Hospitalized Cancer Patients
A Phase 4 study testing Best Practice, Electronic Health Record Review and Interview in people with Advanced Malignant Solid Neoplasm and Delirium, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Neoplasm, Delirium, Hematopoietic and Lymphatic System Neoplasm
- What is being tested?
- Best Practice, Electronic Health Record Review and Interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2025to 24 Apr 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: A Pilot Randomized, Open Label Trial of Orexin Receptor Antagonist for Insomnia in Hospitalized Patients With Cancer to Prevent Delirium
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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:
- 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.
- Conditions
- Advanced Malignant Solid Neoplasm, Delirium, Hematopoietic and Lymphatic System Neoplasm, Insomnia
- Being tested
- Best Practice, Electronic Health Record Review, Interview, Questionnaire Administration, Suvorexant
- Medical subject headings
- Delirium, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive standard of care
Electronic Health Record ReviewOther
Ancillary studies
InterviewOther
Ancillary studies
Questionnaire AdministrationOther
Ancillary studies
SuvorexantDrug
Also called Belsomra, MK-4305
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I (suvorexant, standard of care) | Experimental | 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. Receives: Other: Best Practice; Other: Electronic Health Record Review; Other: Interview; Other: Questionnaire Administration; Drug: Suvorexant |
| Arm II (standard of care) | Active comparator | Patients receive standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity. Receives: Other: Best Practice; Other: Electronic Health Record Review; Other: Interview; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Feasibility will be defined as the ability to recruit 14 patients to the study with 20% or less study attrition.
Measured: Up to 1 year
Secondary outcomes (2)
Adherence to standard of care
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.
Measured: Baseline (enrollment), assessed 3-7 days while in the hospital or until discharged, whichever comes first
Change in Insomnia Severity Index score
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).
Measured: Baseline (enrollment), assessed 3-7 days while in the hospital or until discharged, whichever comes first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start26 Feb 2025
- Primary completion24 Apr 2025
- Study completion24 Apr 2025
Why it stopped: low/slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Regina M. Mackey, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834386
- Sponsor's protocol ID
- 24-005893
- Other IDs
- NCI-2025-00771, 24-005893
- Status last verified
- Apr 2025
- First submitted
- 14 Feb 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Randomized, Open Label Trial of Orexin Receptor Antagonist for Insomnia in Hospitalized Patients With Cancer to Prevent Delirium
- ClinicalTrials.gov ID
- NCT06834386
- Acronym / sponsor ID
- 24-005893
- Conditions
- Advanced Malignant Solid Neoplasm, Delirium, Hematopoietic and Lymphatic System Neoplasm, Insomnia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: low/slow accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 26 Feb 2025 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 24 Apr 2025 (actual)
- First posted
- 19 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (suvorexant, standard of care) | Experimental | Other: Best Practice, Other: Electronic Health Record Review, Other: Interview, Other: Questionnaire Administration, Drug: SuvorexantPatients receive suvorexant PO QD at bedtime and standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity. |
| Arm II (standard of care) | Active comparator | Other: Best Practice, Other: Electronic Health Record Review, Other: Interview, Other: Questionnaire AdministrationPatients receive standard of care for hospital associated insomnia for 3-7 days in the absence of unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (13 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive standard of care | Other | Arm I (suvorexant, standard of care), Arm II (standard of care) |
| Electronic Health Record ReviewAncillary studies | Other | Arm I (suvorexant, standard of care), Arm II (standard of care) |
| InterviewAncillary studies | Other | Arm I (suvorexant, standard of care), Arm II (standard of care) |
| Questionnaire AdministrationAncillary studies | Other | Arm I (suvorexant, standard of care), Arm II (standard of care) |
| SuvorexantAlso: Belsomra, MK-4305Given PO | Drug | Arm I (suvorexant, standard of care) |
Primary outcome
Recruitment
Time frame: Up to 1 year
Feasibility will be defined as the ability to recruit 14 patients to the study with 20% or less study attrition.
2 secondary outcomes
Adherence to standard of care
Time frame: Baseline (enrollment), assessed 3-7 days while in the hospital or until discharged, whichever comes first
Change in Insomnia Severity Index score
Time frame: Baseline (enrollment), assessed 3-7 days while in the hospital or until discharged, whichever comes first
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
Related trials for Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
RecruitingPhase 1/2
A Study of Neladalkib (NVL-655) in Patients With Advanced NSCLC and Other Solid Tumors Harboring ALK Rearrangement or Activating ALK Mutation (ALKOVE-1)
Locally Advanced Solid Tumor, Metastatic Solid Tumor
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingObservational study
Clinical Experience and Real-world Safety and Effectiveness of Envafolimab: Patient Access Program
Advanced Solid Tumor
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Regina M. Mackey, MD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Best Practice, Electronic Health Record Review and Interview in people with Advanced Malignant Solid Neoplasm and Delirium, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025.