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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000985
Receipt No. 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

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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
Obsterics 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
Email 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/
Email cancer@kanazawa-med.ac.jp

Sponsor
Institute Multidisciplinary Cancer Center, Kanazawa Medical University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001141

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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