UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031335 |
|---|---|
| Receipt number | R000035748 |
| Scientific Title | A randomized control trial of herbal medicine for cancer patients that examined influence of IL-6 and cachexy. |
| Date of disclosure of the study information | 2018/02/16 |
| Last modified on | 2018/02/16 16:17:49 |
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Basic information
Public title
A randomized control trial of herbal medicine for cancer patients that examined influence of IL-6 and cachexy.
Acronym
Influence of the herbal medicine
Scientific Title
A randomized control trial of herbal medicine for cancer patients that examined influence of IL-6 and cachexy.
Scientific Title:Acronym
Influence of the herbal medicine
Region
| Japan |
Condition
Condition
colorectal cancer, pancreatic cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Relative dose intensity of first line chemothrapy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MTD, RD,IL-6
Key secondary outcomes
QOL Nutritional assessment
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Hochuekkitou, gosyajinnkigan, keisibukuryogan
Interventions/Control_2
control
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
"(1) Histological proven adenocarcinoma
(2) possible oral intake
(3) unresectable corolectal and pancreatic cancer
(4) KRAS mutation untested or negative or positive
(5) PS 0-1
(6) Adequate organ function
(7) Written informed consent from patients
(8) Capcitabine + Oxalipltain + Bevacizumab regimen in patients with colorectal cancer
(9) Gemcitabine + Nab-paclitaxel in patients with pancreatic cancer
(10) Best surpotive care in study2"
Key exclusion criteria
"(1) Synchronous or metachronous (within 5 years) malignancies except for carcinoma in situ or mucosal tumors curatively treated with local therapy.
(2) Past history of severe hypersensitivity to drugs
(3) Body temperature of over 38 degrees Celsius or active infection
(4) serious bone marrow suppression, a renal damage or a liver damage
(5) Severe complications
(6) Pregnant women, women with the possibility of the pregnancy, or men who want their partners to become pregnant
(7) Psychological disorder
(8) Patients judged inappropriate for the study by the physicians
"
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Gotou |
Organization
Osaka Medical College Hospital
Division name
Chemotherapy Center
Zip code
Address
2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL
072-683-1221
in2030@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshifumi Yamaguchi |
Organization
Osaka Medical College Hospital
Division name
Chemotherapy Center
Zip code
Address
2-7 Daigaku-machi, Takatsuki City, Osaka, Japan
TEL
072-683-1221
Homepage URL
ctc008@osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College Hospital
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research
Organization
Division
Category of Funding Organization
Other
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
| 2018 | Year | 02 | Month | 16 | 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
| 2017 | Year | 12 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 12 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 16 | Day |
Last modified on
| 2018 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035748
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
