UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002343 |
|---|---|
| Receipt number | R000002873 |
| Scientific Title | Randomized phase II clinical study on preventive effects of GPS, healthy food on the incidence of infection cases in stomach and colon cancer patients before and after the abdominal surgery |
| Date of disclosure of the study information | 2009/08/17 |
| Last modified on | 2010/08/17 13:36:09 |
* 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
Randomized phase II clinical study on preventive effects of GPS, healthy food on the incidence of infection cases in stomach and colon cancer patients before and after the abdominal surgery
Acronym
Preventive effects of GPS on the incidence of infection cases in cancer patients before and after surgery
Scientific Title
Randomized phase II clinical study on preventive effects of GPS, healthy food on the incidence of infection cases in stomach and colon cancer patients before and after the abdominal surgery
Scientific Title:Acronym
Preventive effects of GPS on the incidence of infection cases in cancer patients before and after surgery
Region
| Japan |
Condition
Condition
stomach and colon cancer patients
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Preventive effects on infection incidence and recovery effects of physical and mental defects due to surgical stress by administration of GPS, immune enhancing yeast glucopolysaccharide to stomach and colon cancer patients before and after surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
incidence of Surgical Site Infection
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
GPS group
250mg of GPS (a cupsel contain 125mg of GPS) are orally taken continuously for 3 days before operation and for 27days after opperation.
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who are going to take surgical operation on stomac or colon cancer.
Key exclusion criteria
1. Sevier compromised patient(more than PS3)
2. Patient of SHOWKAKAN KYOUSAKU or breading
3. SHINKOUSEI infectious patient
4. Urgent operation patient
5. ZOUKIFUZEN patient
6. Uncontrollable patients together with diabetes mellitus and treated with insulin
7. Suspected cases allergic to yeasts
8. Patient who has been treated with chemotherapy
9. Other patients who are considered to be ruled out by the doctor concerned
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Professor Kenji Ogawa |
Organization
Tokyo wemen college of medicine,
East clinical center
Division name
Surgicaldepartment
Zip code
Address
2-1-10 Nishioku,akawa-ku,Tokyo 1160-8567,Japan
TEL
03-3810-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsunesuke Kajimoto, Ph.D. |
Organization
Nippon Biothera Co., Ltd.
Division name
Healthcare Division
Zip code
Address
2-3-26 Kudanminami,Chiyoda-ku,Tokyo 102-00074,Japan
TEL
03-5276-0212
Homepage URL
t.kajimoto@nipponbiothera.co.jp
Sponsor or person
Institute
Research institute of cancer chemotherapy
Institute
Department
Personal name
Funding Source
Organization
Nippon Biothera Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2009 | Year | 08 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 17 | Day |
Last modified on
| 2010 | Year | 08 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002873
