UMIN-ICDS Clinical Trial

Public title

Efficacy of orexin receptor antagonists for the prevention of delirium in cancer patients: a systematic review

Acronym

Efficacy of orexin receptor antagonists for the prevention of delirium in cancer patients: a systematic review

Scientific Title

Efficacy of orexin receptor antagonists for the prevention of delirium in cancer patients: a systematic review

Scientific Title:Acronym

Efficacy of orexin receptor antagonists for the prevention of delirium in cancer patients: a systematic review

Region

Japan

Condition

Cancer

Classification by specialty

Hematology and clinical oncology

Psychiatry

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To evaluate the efficacy of orexin receptor antagonists for the prevention of delirium in cancer patients

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Incidence of delirium

Key secondary outcomes

1. Severity of delirium
2. Somnolence
3. Tumbling and falls

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients with cancer (more than or equal to 80%)
2. Patients without delirium before intervention
3. Studies examining the efficacy or safety of orexin receptor antagonists for the prevention of delirium in adult cancer patients

The study design to be considered for inclusion is as follows:
1. If there were at least two randomized controlled trial (RCT)s, inclusion was completed.
2. If there were less than 2 RCTs, we included non-RCTs or observational studies with control groups.
3. If there were no RCTs/non-RCTs/observational studies with control groups, single-arm observational studies were considered for inclusion.

Key exclusion criteria

1. Duplicated publications
2. Conference proceedings
3. Reviews which are not based on systematic review
4. Study protocols
5. Case reports and case series
6. Articles written in languages other than English or Japanese

Target sample size

Name of lead principal investigator

1st name	Shuntaro
Middle name
Last name	Yasuda

Organization

Tokyo Medical and Dental University Hospital

Division name

Department of Pharmacy

Zip code

113-8519

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-3813-6111

Email

shun-yasuda@umin.ac.jp

Name of contact person

1st name	Shuntaro
Middle name
Last name	Yasuda

Organization

Tokyo Medical and Dental University Hospital

Division name

Department of Pharmacy

Zip code

113-8519

Address

1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan

TEL

03-3813-6111

Homepage URL

Email

shun-yasuda@umin.ac.jp

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

N/A

Address

N/A

Tel

N/A

Email

N/A

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

08

Month

03

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

07

Month

31

Day

Date of IRB

Anticipated trial start date

2023

Year

09

Month

01

Day

Last follow-up date

2024

Year

08

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1. Data sources and search strategy
We will conduct a systematic review to evaluate efficacy and safety of orexin receptor antagonists for the prevention of delirium in adult cancer patients. This systematic review will search the following four databases: PubMed, the Cochrane Central Register of Controlled Trial (CENTRAL), Cochrane Database of Systematic Reviews (CDSR) and Ichushi-Web of the Japan Medical Abstracts Society ver.5. The searches will be limited to articles published prior to August 31, 2023. The search will include all relevant terms such as "orexin receptor antagonists," "suvorexant," and "lemborexant," in combination with terms such as "delirium," "cancer," and "prevention". Additional articles were identified using a manual search.

2. Selection of studies and assessment of risk of bias in included studies
Two reviewers will independently screen the titles, abstracts and full-text articles to select studies that meet the inclusion criteria. Two reviewers will independently assess the included studies for risk of bias according to the Minds Manual for Guideline Development 2020 ver. 3.0. Any disagreement was resolved by discussion and consensus, with a referral to a third reviewer where necessary.

Registered date

2023

Year

08

Month

03

Day

Last modified on

2023

Year

09

Month

01

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059130