UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000011092
Receipt No. R000012909
Scientific Title A clinical study of the efficacy of 5HT3 receptor antagonist (palonocetron) in malignant lymphoma patients treated with (R-)CHOP regimen
Date of disclosure of the study information 2013/08/01
Last modified on 2019/12/11 (Ver. 5)

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Basic information
Public title A clinical study of the efficacy of 5HT3 receptor antagonist (palonocetron) in malignant lymphoma patients treated with (R-)CHOP regimen
Acronym A clinical study of the efficacy of palonocetron in patients treated with (R-)CHOP regimen
Scientific Title A clinical study of the efficacy of 5HT3 receptor antagonist (palonocetron) in malignant lymphoma patients treated with (R-)CHOP regimen
Scientific Title:Acronym A clinical study of the efficacy of palonocetron in patients treated with (R-)CHOP regimen
Region
Japan

Condition
Condition Malignant Lymphoma
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 we intent to evaluate the efficacy of palonocetron to prevent nausea and vomiting in patients treated with (R-)CHOP regimen
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of nausea, vomiting, and anorexia
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Behavior,custom
Interventions/Control_1 we use palonosetron as anti-emesis drug, and ask patients to fill out an emesis diary
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)The patients who are historically confirmed as Non-Hodgikin Lymphoma, and planed to treat with (R-)CHOP regimen
2)The patients who don't have nausea or vomiting
3)The patients who have not been treated with chemotherapy
4)The patients who are expected to survive more than 3 months
5)The patients whose ECOG performance status are 0 to 2
6)The patients who are able to fill out an emesis diary
7)The patients who are more than 18 years old, and agree to participate in this study with document
Key exclusion criteria 1)The patients who will have nausea and vomiting except for chemotherapy
2)The patients who have contraindication to use palonocetron
3)The patients who need to reduce CHOP regimen
4)The patients who need to reduce or stop to use prednisolone
5)The patients who are HIV antibody positive, HBs antigen positive, or HCV antibody positive
6)The patients whose doctor judge as ineligible
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironobu Minami
Organization Department of Medicine, Kobe University Graduate School of Medicine
Division name Division of Medical Oncology/Hematology
Zip code
Address 7-5-1, Kusunoki-Cho, Chuo-ku, Kobe city, Hyogo prefecture, Japan
TEL 078-382-5820
Email yhmiyata@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiharu Miyata
Organization Department of Medicine, Kobe University Graduate School of Medicine
Division name Division of Medical Oncology/Hematology
Zip code
Address 7-5-1, Kusunoki-Cho, Chuo-ku, Kobe city, Hyogo prefecture, Japan
TEL 078-382-5820
Homepage URL
Email yhmiyata@med.kobe-u.ac.jp

Sponsor
Institute Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine, Kobe, Japan
Institute
Department

Funding Source
Organization Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine, Kobe, Japan
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
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
2013 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://link.springer.com/article/10.1007%2Fs12185-016-2089-9
Number of participants that the trial has enrolled 50
Results 
The primary endpoint was the overall occurrence rate of nausea, vomiting, and anorexia; these rates were 56%, 12%, and 62%, respectively, including all grades.
Results date posted
2019 Year 12 Month 11 Day
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
2013 Year 07 Month 17 Day
Date of IRB
2013 Year 07 Month 24 Day
Anticipated trial start date
2013 Year 08 Month 01 Day
Last follow-up date
2015 Year 05 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 07 Month 02 Day
Last modified on
2019 Year 12 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012909