UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034613 |
|---|---|
| Receipt number | R000039464 |
| Scientific Title | The Exploratory Study about Efficacy and Safety of Ninjin'yoeito for Fatigue and Malaise Expressed in Postoperative Patients with Colorectal Cancer |
| Date of disclosure of the study information | 2018/11/15 |
| Last modified on | 2018/10/24 00:59:55 |
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Basic information
Public title
The Exploratory Study about Efficacy and Safety of Ninjin'yoeito for Fatigue and Malaise Expressed in Postoperative Patients with Colorectal Cancer
Acronym
The Exploratory Study about Efficacy and Safety of Ninjin'yoeito in Postoperative Patients with Colorectal Cancer
Scientific Title
The Exploratory Study about Efficacy and Safety of Ninjin'yoeito for Fatigue and Malaise Expressed in Postoperative Patients with Colorectal Cancer
Scientific Title:Acronym
The Exploratory Study about Efficacy and Safety of Ninjin'yoeito in Postoperative Patients with Colorectal Cancer
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy and safety of Ninjin'yoeito for fatigue and malaise expressed in postoperative elderly patients with colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fatigue and Malaise: The Evaluation by Chaludder fatigue questionnaire
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The administration of Ninjin'yoeito
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
| 80 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients with resected colorectal cancer (clinical stage I to IIIb)
2) Patients with Grade 1 or higherfatigue or malaise after surgery (CTCAE ver. 4.0)
3) Patients with ECOG PS 0 to 2
4) Patients whose main organ functions are adequately maintained
5) Age: over 80 years old (when acquiring consent)
6) Category of examination: Outpatient and hospitalization
7) Patients who can be orally administered
8) Patients who wrote consent form to participate in this study
Key exclusion criteria
1) Patients with active other cancers
2) Patients with severe complications (such as liver disease, renal disease, heart disease, blood disease or metabolic disease) or mental disease
3) Patients taking drugs banned in this study or Ninjin'yoeito within 4 weeks before the start of the study
4) Patients who have a history of allergies to traditional Chinese medicine
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fujii Tsutomu |
Organization
Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama
Division name
Department of Surgery and Science
Zip code
Address
2630, Sugitani, Toyama
TEL
076-434-7331
surgery2@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Baba Hayato |
Organization
Graduate School of Medicine and Pharmaceutical Sciences, University of Toyama
Division name
Department of Surgery and Science
Zip code
Address
2630, Sugitani, Toyama
TEL
076-434-7331
Homepage URL
hayato.bb@gmail.com
Sponsor or person
Institute
University of Toyama
Institute
Department
Personal name
Funding Source
Organization
University of Toyama
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
| 2018 | Year | 11 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 11 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 01 | Month | 01 | 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 | 10 | Month | 24 | Day |
Last modified on
| 2018 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039464
