UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001235 |
|---|---|
| Receipt number | 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 20:40:57 |
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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
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
meguro@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine First Department of Surgery
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001447
