UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000985 |
|---|---|
| Receipt number | R000001141 |
| Scientific Title | Randomized controlled trial on the usefulness of hochuekkito for fatigue and anorexia during cancer chemotherapy |
| Date of disclosure of the study information | 2008/01/20 |
| Last modified on | 2014/01/19 09:20:39 |
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Basic information
Public title
Randomized controlled trial on the usefulness of hochuekkito for fatigue and anorexia during cancer chemotherapy
Acronym
Hochuekkito for the side effects of cancer chemotharapy
Scientific Title
Randomized controlled trial on the usefulness of hochuekkito for fatigue and anorexia during cancer chemotherapy
Scientific Title:Acronym
Hochuekkito for the side effects of cancer chemotharapy
Region
| Japan |
Condition
Condition
Cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Hematology and clinical oncology | Nephrology | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Chest surgery | Breast surgery |
| Obstetrics and Gynecology | Dermatology | Oto-rhino-laryngology |
| Urology | Oral surgery | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim is to clarify the usefulness of hochuekkito for fatigue and anorexia during cancer chemotherapy in a randomized controlled trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II,III
Assessment
Primary outcomes
Subjective symptoms such as fatigue and anorexia, and quality of life
Key secondary outcomes
Rate of treatment accomplishment, dose intensity, and median survival time
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
oral administration of hochuekkito
Interventions/Control_2
no treatment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosis: histologically-proven cancer patients of any organs
Disease duration: no limitation
Severity: no limitation of cancer stage, performance status (PS): 0-2, capable of outpatient setting
Key exclusion criteria
Present illness: no limitation
Past history: no limitation
Combined treatment: no limitation
Combined drugs: Kampo drugs other than hochuekkito, and vitamins etc can be continued. New addition of these drugs is prohibited.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiharu MOTOO |
Organization
Kanazawa Medical University
Division name
Multidisciplinary Cancer Center
Zip code
Address
1-1 Daigaku, Uchinada, Ishikawa 920-0293, Japan
TEL
076-286-2211
motoo@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiharu MOTOO |
Organization
Kanazawa Medical University
Division name
Multidisciplinary Cancer Center
Zip code
Address
1-1 Daigaku, Uchinada, Ishikawa 920-0293, Japan
TEL
076-286-2211
Homepage URL
http://www.kanazawa-med.ac.jp/
cancer@kanazawa-med.ac.jp
Sponsor or person
Institute
Multidisciplinary Cancer Center, Kanazawa Medical University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Foundation for Multidisciplinary Treatment of Cancer
Organization
Division
Category of Funding Organization
Non profit foundation
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
金沢医科大学病院
Other administrative information
Date of disclosure of the study information
| 2008 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2007 | Year | 12 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 07 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 10 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2008 | Year | 01 | Month | 19 | Day |
Last modified on
| 2014 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001141
