UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016085 |
|---|---|
| Receipt number | R000018685 |
| Scientific Title | Phase I study of the preventive effect of Kampo medicine on oxaliplatin-induced peripheral neurotoxicity |
| Date of disclosure of the study information | 2014/12/29 |
| Last modified on | 2019/01/18 16:35:49 |
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Basic information
Public title
Phase I study of the preventive effect of Kampo medicine on oxaliplatin-induced peripheral neurotoxicity
Acronym
The preventive effect of Kampo medicine on oxaliplatin-induced peripheral neurotoxicity
Scientific Title
Phase I study of the preventive effect of Kampo medicine on oxaliplatin-induced peripheral neurotoxicity
Scientific Title:Acronym
The preventive effect of Kampo medicine on oxaliplatin-induced peripheral neurotoxicity
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This is the phase I study of the preventive effect of Kampo medicine on oxaliplatin-induced peripheral neurotoxicity as to adjuvant chemotherapy for patients with stage II and III colorectal cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Decision of DLT, MTD, RD of Kampo medicine (TJ-3023, TJ-18)
Key secondary outcomes
Decision of RDI of oxaliplatin, Examination for oxaliplatin-induced peripheral neurotoxicity (neurosensory test, QOL)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
During XELOX regimen, Kampo medicine is administered as follows: Level 1(TJ-18 7.5g, TJ-3023 0g), Level 2(TJ-18 7.5g, TJ-3023 1.5g), Level 3(TJ-18 7.5g, TJ-3023 3.0g)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.histopathological colorectal cancer
2.stage II or III
3.adjuvant chemotherapy using oxaliplatin
4. more than 20 yeras old
5. ECOG Performance Status 0-1
6.no organ failure
7.no chemotherapy
8.informed consent
Key exclusion criteria
1.having resistance for using Kampo
2. chemotherapy using oxaliplatin has been performed
3.having double cancer
4.having serious sensory disturbance
5.having serious drug hypersensitivity
6. having serious infection
7. having serious psycho-neurologic disease
8.having serious complication as follows: uncontrorable diabetes mellitus, uncontrorable hypertension, interstitial pneumonia or pulmonary fibrosis, ileus, and serious heart disease
9. inappropriate judgment for study by clinical investigator
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsukasa Hotta |
Organization
Wakayama Medical University,
School of Medicine
Division name
Second Department of Surgery
Zip code
Address
811-1, Kimiidera, Wakayama 641-8510, Japan
TEL
073-441-0613
hotta@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsukasa Hotta |
Organization
Wakayama Medical University, School of Medicine
Division name
Second Department of Surgery
Zip code
Address
811-1, Kimiidera, Wakayama 641-8510, Japan
TEL
073-441-0613
Homepage URL
hotta@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University,
School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University,
School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
| 2014 | Year | 12 | Month | 29 | 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
| 2014 | Year | 05 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | Month | 29 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 29 | Day |
Last modified on
| 2019 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018685
