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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001235
Receipt No. R000001447
Scientific Title Clinical study to examine the effectiveness of Juzentaihoto in postoperative recovery for colorectal cancer patients - A research investigating the role of cell-mediated immunity in recovery
Date of disclosure of the study information 2008/07/08
Last modified on 2012/04/02

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Basic information
Public title Clinical study to examine the effectiveness of Juzentaihoto in postoperative recovery for colorectal cancer patients - A research investigating the role of cell-mediated immunity in recovery
Acronym Clinical study to examine the effectiveness of Juzentaihoto in postoperative recovery for colorectal cancer patients - A research investigating the role of cell-mediated immunity in recovery
Scientific Title Clinical study to examine the effectiveness of Juzentaihoto in postoperative recovery for colorectal cancer patients - A research investigating the role of cell-mediated immunity in recovery
Scientific Title:Acronym Clinical study to examine the effectiveness of Juzentaihoto in postoperative recovery for colorectal cancer patients - A research investigating the role of cell-mediated immunity in recovery
Region
Japan

Condition
Condition Colorectal Cancer
Classification by specialty
Surgery in general Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To explore the effects of Juzentaihoto on postoperative recovery of colorectal cancer patients by evaluating ECOG's Performance Status, weight, QOL-ACD, blood cell components, serum albumin level, cell-mediated immune response and blood cytokine level.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 1.ECOG's Performance Status (ECOG=Eastern Cooperative Oncology Group)
2.Weight
3.QOL-ACD (The QOL Questionnaire for Cancer Patients Treated with Anticancer Drugs)
4.Hematological test (RBC, Hb, Ht, WBC, differential leukocyte count, PLT)
5.Serum albumin
6.Cell-mediated immunity (HLA-DR/CD3, CD11b/CD8, NK-cell activity)
7.Blood cytokine (IL-6, IL-10, IL-12, IL-18, TGF-beta, IFN-gamma)
8.Carcinoembryonic antigen (CEA)
9.Recurrence of cancer
10.Metastasis of cancer
11.Duration of anticancer drug therapy
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Juzentaihoto is administered orally 7.5g/day in 2-3 dosages, before or between meals
Total duration of test: 24 weeks starting from one week after surgery
Interventions/Control_2 Juzentaihoto is not administered.
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
79 years-old >=
Gender Male and Female
Key inclusion criteria 1.Patients with stage II or III colorectal cancer (confirmed histologically and cytologically) who had surgical resection
2.Patients who do not have concomitant, active double or multiple cancer
3.Age (at the time of informed consent): between 20 and 79 years old
4.Gender: no specification
5.Consultation division: no specification
6.Patients who have signed a written, informed consent
Key exclusion criteria 1.Patients who did not have complete resection of their bowels
2.Patients who took Traditional Japanese Medicine within four weeks of their surgery
3.Patients who are unable to take the test medication one week after the surgery
4.Patients with preoperative laboratory values falling within the ranges as described below, and their main organs (bone marrow, heart, lungs, kidneys and liver) show advanced, functional disorders:
*WBC<or=4,000/mm3 or 12,000/mm3<or=WBC
*Platelets<or=100,000/mm3
*Hemoglobin<or=10g/dl
*AST (SGOT serum glutamic-oxaloacetic transaminase) > 2x above upper normal range
*ALT (SGPT serum glutamic-pyruvic transaminase) > 2x above upper normal range
*Serum total bilirubin>or=2.0mg/dl
*BUN<or=25mg/dl
*Serum creatinine >or=1.5mg/dl
5.Patients who have serious, postoperative complications including infection, diarrhea (watery stool), tube paralysis, bowel obstruction with pleural effusion, ascites or hydropericardium
6.Patients who have clinically active inflammation or complication
7.Patients who are pregnant or are possibly pregnant
8.Patients who fail to meet the eligibility criteria for the study
9.Patients who are unable to sign a written consent
10. Patients who are determined to be unfit for the study by the physician in charge of the research
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Meguro
Organization Sapporo Medical University School of Medicine
Division name First Department of Surgery
Zip code
Address South-1, West-16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL 011-611-2111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Meguro
Organization Sapporo Medical University School of Medicine
Division name First Department of Surgery
Zip code
Address South-1, West-16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL 011-611-2111
Homepage URL
Email meguro@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University School of Medicine First Department of Surgery
Institute
Department

Funding Source
Organization Tsumura Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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
2008 Year 07 Month 08 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 Completed
Date of protocol fixation
2008 Year 04 Month 07 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 01 Day
Last follow-up date
2011 Year 09 Month 01 Day
Date of closure to data entry
2011 Year 09 Month 01 Day
Date trial data considered complete
2011 Year 10 Month 01 Day
Date analysis concluded
2011 Year 10 Month 01 Day

Other
Other related information

Management information
Registered date
2008 Year 07 Month 08 Day
Last modified on
2012 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001447

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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