UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011092 |
|---|---|
| Receipt number | 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 17:32:12 |
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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
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
yhmiyata@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Medical Oncology/Hematology, Department of Medicine, Kobe University Graduate School of Medicine, Kobe, Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012909
| Research Plan | |
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