UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050958 |
|---|---|
| Receipt number | R000057909 |
| Scientific Title | Palonosetron for prevention of delayed chemotherapy-induced nausea and vomiting in pediatric patients: a meta-analysis |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2024/04/15 08:33:20 |
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Basic information
Public title
Palonosetron for prevention of delayed chemotherapy-induced nausea and vomiting in pediatric patients: a meta-analysis
Acronym
Palonosetron for prevention of delayed chemotherapy-induced nausea and vomiting in pediatric patients: a meta-analysis
Scientific Title
Palonosetron for prevention of delayed chemotherapy-induced nausea and vomiting in pediatric patients: a meta-analysis
Scientific Title:Acronym
Palonosetron for prevention of delayed chemotherapy-induced nausea and vomiting in pediatric patients: a meta-analysis
Region
| Japan |
Condition
Condition
Chemotherapy-induced nausea and vomiting
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the efficacy of palonosetron for CINV in pediatric patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Complete response (CR: defined as no emesis and no rescue medication) rate for delayed CINV, defined as occurring CINV after 24 hours from chemotherapy, between palonosetron and first-generation 5-HT3 receptor antagonist in pediatric patients.
Key secondary outcomes
CR for overall CINV
CR for acute CINV, defined as CINV occurring within 24 hours from chemotherapy
Incidence of adverse events
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
| Not applicable |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
We will include randomized controlled trials (RCT) comparing palonosetron with first-generation 5-HT3 receptor antagonists for CINV, evaluating CR in pediatric patients.
Key exclusion criteria
Exclude the following
1. Clinical trials comparing different combination regimens including 5-HT3 receptor antagonists and other antiemetics.
2. Incomplete information or data.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Hokkaido University Hospital
Division name
Department of Pharmacy
Zip code
060-8648
Address
Kita-14-jo, Nishi-5-chome, Kita-ku, Sapporo, Japan
TEL
011-706-5681
y-atsushi@huhp.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Yamaguchi |
Organization
Hokkaido University Hospital
Division name
Department of Pharmacy
Zip code
060-8648
Address
Kita-14-jo, Nishi-5-chome, Kita-ku, Sapporo, Japan
TEL
011-706-5681
Homepage URL
y-atsushi@huhp.hokudai.ac.jp
Sponsor or person
Institute
Department of Pharmacy, Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Not applicable.
Address
Not applicable
Tel
Not applicable
Not applicable
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 | 05 | 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
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 12 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 12 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 12 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We will perform a meta-analysis according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) statement. We will develop a search strategy to identify related records, with no language restriction, for MEDLINE/PubMed, Embase, Cochrane Library, Web of Science from database inception to March 31, 2023. The search terms will include palonosetron, chemotherapy-induced nausea and vomiting, and randomized controlled trial. Screening and data extraction will be conducted two individuals. We will extract the following data: author, publication year, study design, intervention, CR, incidence of adverse events. Data will be analyze using Review Manager 5.4 software and R. Meta-analysis will be performed using the fixed or random effects model and the Mantel-Haenszel (M-H) method. We will calculate the odds ratio (OR) and 95% confidence interval (95% CI). Statistical significance will be defined as a Z index p-value<0.05. The heterogeneity among studies will be assessed using the Cochran Q test (Chi2) and the I2 statistics: Chi2 p-value <0.1 will correlate high heterogeneity; I2<25%, 25%-50%, and >50% will indicate low, moderate, and high heterogeneity, respectively. To explore the possibility of publication bias, we will generate funnel plots (visual inspection) and will perform Begg's test (rank correlation) and Egger's test (linear regression); an asymmetric funnel plot and a p-value<0.1 implied potential publication bias. Bias risk will be assess using Cochrane Risk of Bias (RoB) Tool.
Management information
Registered date
| 2023 | Year | 04 | Month | 28 | Day |
Last modified on
| 2024 | Year | 04 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057909
