UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000010165
Receipt No. R000011903
Scientific Title A prospective cohort study to search for a risk factor of chemotherapy induced nausea and vomiting in patients with colorectal cancer.
Date of disclosure of the study information 2013/03/05
Last modified on 2013/03/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title A prospective cohort study to search for a risk factor of chemotherapy induced nausea and vomiting in patients with colorectal cancer.
Acronym A prospective cohort study to search for a risk factor of chemotherapy induced nausea and vomiting in patients with colorectal cancer.
Scientific Title A prospective cohort study to search for a risk factor of chemotherapy induced nausea and vomiting in patients with colorectal cancer.
Scientific Title:Acronym A prospective cohort study to search for a risk factor of chemotherapy induced nausea and vomiting in patients with colorectal cancer.
Region
Japan

Condition
Condition colorectal cancer
Classification by specialty
Gastroenterology Hematology and clinical oncology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We search for a risk factor of chemotherapy induced nausea and vomiting in the colorectal cancer patient who performed standard antiemetic therapy.
Basic objectives2 Others
Basic objectives -Others To search for a risk factor of chemotherapy induced nausea and vomiting in the colorectal cancer patient who performed standard antiemetic therapy.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Complete response rate during 24 to 120 hours (delay phase) after an anticancer agent dosage start
Key secondary outcomes 1. Complete response rate during 0 to 24 hours (acute phase) and 0 to 120 hours (all phase ) after an anticancer agent dosage start
2. Complete control rate during acute phase and delay phase and all phase after an anticancer agent dosage start
3. Grade of nausea during acute phase and delay phase and all phase after an anticancer agent dosage start

Base
Study type Observational

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. The patient who plans the medication of the following anticancer agents as colorectal cancer chemotherapy
CPT-11 or oxaliplatin
2. The patient whom an anticancer agent is not given to or an anticancer agent of low emetic risk has been given to in the past
3. The planned patient who gives the following antiemetic drugs in the time giving an anticancer agent
day 1 palonosetron (0.75mg) i.v.
dexamethasone (9.9mg) i.v.
day 2, 3 dexamethasone (8mg) p.o.
4. Age at the time of the registration is a patient 20 years or older
5. The patient who can fill in a diary with a symptom exactly
6. Given written informed consent
Key exclusion criteria 1. The patient who experienced nausea or vomiting within 24 hours before giving an anticancer agent
2. Any other inadequacy for this study
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Itaru Endo
Organization Yokohama city university graduate school of medicine
Division name Department of gastroenterological surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuki Watanabe
Organization Yokohama City University Hospital
Division name Department of gastroenterological surgery
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL
Homepage URL
Email

Sponsor
Institute Yokohama City University Hospital
Institute
Department

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
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 横浜市立大学附属病院
横浜市立大学附属市民総合医療センター
国立病院横浜医療センター
横浜市立市民病院
藤沢市民病院
横須賀共済病院
横須賀市立市民病院
横浜市立みなと赤十字病院
済生会横浜市南部病院
済生会若草病院
横浜船員保険病院
横浜掖済会病院
長津田厚生総合病院
NTT東日本関東病院
市立伊東市民病院

Other administrative information
Date of disclosure of the study information
2013 Year 03 Month 05 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 Open public recruiting
Date of protocol fixation
2013 Year 02 Month 26 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective study

Management information
Registered date
2013 Year 03 Month 05 Day
Last modified on
2013 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011903

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.