UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010165 |
|---|---|
| Receipt number | 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 14:03:23 |
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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
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
Sponsor or person
Institute
Yokohama City University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011903
