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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000002343
Receipt No. 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

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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
Email

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
Email t.kajimoto@nipponbiothera.co.jp

Sponsor
Institute Research institute of cancer chemotherapy
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002873

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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