UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051786 |
|---|---|
| Receipt number | R000059099 |
| Scientific Title | Efficacy of Ramelteon for preventing delirium in cancer patients: a systematic review |
| Date of disclosure of the study information | 2023/08/01 |
| Last modified on | 2023/08/31 19:38:09 |
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Basic information
Public title
Efficacy of Ramelteon for preventing delirium in cancer patients: a systematic review
Acronym
Efficacy of Ramelteon for preventing delirium in cancer patients: a systematic review
Scientific Title
Efficacy of Ramelteon for preventing delirium in cancer patients: a systematic review
Scientific Title:Acronym
Efficacy of Ramelteon for preventing delirium in cancer patients: a systematic review
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Hematology and clinical oncology | Psychiatry |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify the efficacy of Ramelteon for preventing delirium in patients with cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Delirium incidence
Key secondary outcomes
delirium severity, somnolence, tumbling and falls
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
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
Eligibility
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 Ramelteon 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.Duplicate publications
2.Conference proceedings
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Saho |
| Middle name | |
| Last name | Wada |
Organization
National Cancer Cente
Division name
Division of Quality Assurance Programs
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan.
TEL
03-3542-2511
sawada@ncc.go.jp
Public contact
Name of contact person
| 1st name | Saho |
| Middle name | |
| Last name | Wada |
Organization
National Cancer Center
Division name
Division of Quality Assurance Programs
Zip code
104-0045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo, Japan.
TEL
03-3542-2511
Homepage URL
sawada@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
N/A
Address
N/A
Tel
N/A
N/A
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
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
Progress
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
Other related information
Data sources and search strategy.
We will conduct a systematic review of randomized clinical trials to verify the effectiveness of Ramelteon for preventing delirium in cancer patients. This systematic review will search the following four databases: the Ichushi-Web of the Japan Medical Abstracts Society ver.5, Cochrane Library, EMBASE and MEDLINE, on 0831 2023. The search will include all relevant terms such as "Delirium,""Ramelteon," and"Melatonin receptor agonist*."
Selection of studies and Assessment of risk of bias in included studies.
Two review authors will independently check to ensure that studies meet the inclusion criteria. Two review authors will independently assess trial quality according to the Minds 2020 manual. If the raters disagree, the final rating will be made by consensus with the involvement, if necessary, of another review author.
Management information
Registered date
| 2023 | Year | 08 | Month | 01 | Day |
Last modified on
| 2023 | Year | 08 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059099
