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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005268
Receipt No. R000006265
Scientific Title Efficacy of palonosetoron compared with granisetron for prevention of chemotherapy-induced nausea and vomiting (CINV) using MASCC antiemetic tool
Date of disclosure of the study information 2011/03/17
Last modified on 2013/10/17

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Basic information
Public title Efficacy of palonosetoron compared with granisetron for prevention of chemotherapy-induced nausea and vomiting (CINV) using MASCC antiemetic tool
Acronym Efficacy of palonosetoron compared with granisetron for prevention of CINV using MAT
Scientific Title Efficacy of palonosetoron compared with granisetron for prevention of chemotherapy-induced nausea and vomiting (CINV) using MASCC antiemetic tool
Scientific Title:Acronym Efficacy of palonosetoron compared with granisetron for prevention of CINV using MAT
Region
Japan

Condition
Condition Lung cancer, Colon cancer, Breast cancer
Classification by specialty
Pneumology Hematology and clinical oncology Gastrointestinal surgery
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate efficacy of Palonosetoron compared with granisetoron using MAT and FLIE in HEC or MEC.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Score of delayed CINV in MAT
Key secondary outcomes 1)Score of nausea in FLIE
2)Score of vomiting in FLIE
3)Number of delayed vomiting
4)Number of acute vomiting
5)Number of acute nausea
6)Number of acute vomiting
7)Plasma concentration of 5-HIAA, Substance P and ghrelin

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Paronosetoron 0.75mg d.i.v. 30 min prior to chemotherapy on Day1
Interventions/Control_2 Granisetoron 3mg d.i.v. 30 min prior to chemotherapy on Day1
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patient receiving HEC or MEC defined by Japan Society of Clinical Oncology guideline 2010, ver 1
2)ECOG performance status of 0-2
3)Acquisition of written informed consent
Key exclusion criteria 1)Patient with dementia
2)Concurrent brain radiotherapy
3)Serious infections
4)Clinical brain metastasis
5)Massive pericardial, pleural effusion, or ascites
6)Vestibular disorder
7)Clinical hypercalcaemia or hyponatremia
8)Clinical uremia
9)Ireus or sub-ireus
10)Serious clinical probrems
11)Previous drug allergy
12)Hoped to be pregnant/ nursing
13)Those judged to be not suitable by the attending physician

Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukari Tsubata
Organization Shimane University Faculty of Medicine
Division name Division of Clinical Oncology and Respiratory Medicine
Zip code
Address 89-1, Enya-cho, Izumo, Shimane
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Shimane University Faculty of Medicine
Division name Division of Clinical Oncology and Respiratory Medicine
Zip code
Address 89-1, Enya-cho, Izumo, Shimane
TEL
Homepage URL
Email

Sponsor
Institute Shimane University Faculty of Medicine
Division of Clinical Oncology and Respiratory Medicine
Institute
Department

Funding Source
Organization Shimane University Faculty of Medicine
Division of Clinical Oncology and Respiratory Medicine
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2011 Year 03 Month 17 Day

Related information
URL releasing protocol
Publication of results Published

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
2011 Year 07 Month 28 Day
Date of IRB
Anticipated trial start date
2011 Year 08 Month 01 Day
Last follow-up date
2013 Year 08 Month 31 Day
Date of closure to data entry
2013 Year 08 Month 31 Day
Date trial data considered complete
2013 Year 08 Month 31 Day
Date analysis concluded
2013 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2011 Year 03 Month 17 Day
Last modified on
2013 Year 10 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006265

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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