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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004287
Receipt No. R000005135
Scientific Title Double-Blind , Placebo-Controlled Randomized Phase II Study of Hangeshashinto for Prevention of Oral Mucositis in Colorectal Cancer Patients Receiving Chemotherapy (HANGESHA-C Study).
Date of disclosure of the study information 2010/10/01
Last modified on 2018/09/20

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Basic information
Public title Double-Blind , Placebo-Controlled Randomized Phase II Study of Hangeshashinto for Prevention of Oral Mucositis in Colorectal Cancer Patients Receiving Chemotherapy (HANGESHA-C Study).
Acronym Placebo-Controlled RPII Study of Hangeshashinto for Prevention of Oral Mucositis in CRC Pts Receiving Chemotherapy(HANGESHA-C Study).
Scientific Title Double-Blind , Placebo-Controlled Randomized Phase II Study of Hangeshashinto for Prevention of Oral Mucositis in Colorectal Cancer Patients Receiving Chemotherapy (HANGESHA-C Study).
Scientific Title:Acronym Placebo-Controlled RPII Study of Hangeshashinto for Prevention of Oral Mucositis in CRC Pts Receiving Chemotherapy(HANGESHA-C Study).
Region
Japan

Condition
Condition Colorectal Cancer
Classification by specialty
Gastroenterology Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of Hangeshashinto for prevention and treatment of oral mucositis in colorectal cancer patients receiving chemotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Incidence of oral mucositis. grade>=2
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of Hangeshashinto 7.5g/day t.i.d. after meals.
Interventions/Control_2 Oral administration of Placebo 7.5g/day t.i.d. after meals.
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)Receiving chemotherapy.
(2)Oral mucositis in previous chemotherapy course.
(3)ECOG P.S. of 0 or 1.
(4)age of 20 years or older.
(5)A life expectancy of more than 12 weeks.
(6)Adequate function of vital organs, laboratory data within 7 days.
WBC >=3,000/mm3 and <=12,000mm3.
Neutrophil >=1,500/mm3
platelet >=100,000/mm3
AST and ALT
<=2.5 ULN or <=5.0 ULN if the patient has liver metastasis aspartate aminotransferase and alanine
T-Bil <=1.5 ULN
Cr <=UNL
(7)Written informed consent.
Key exclusion criteria (1)blood transfusion or hemopoietic factors (e.g.G-CSF) within 7 days .
(2)Not using traditional Japanese medicines (Kampo) within 2 weeks.
(3)Serious drug allergy..
(4)Current analgesic treatment.
(5)Neuropathy or sensory dysfunction.
(6)Active double cancer.
(7)Uncontrolled pleural effusion or ascites.
(8)Clinically significant infection.
(9)Brain metastasis.
(10)Clinically significant electrocardiographic abnormality.
(11)Clinically significant heart disease (myocardial infarction within 12 months, etc.).
(12)Clinically significant pulmonary disease
(13)Gastrointestinal bleeding that requires medication or transfusion.
(14)Watery diarrhea..
(15)Myelosuppresion.
(16)Ileus or bowel obstruction.
(17)Central nervous system disorders.
(18)Dementia.
(19)Serious psychological disease.
(20)Uncontrolled diabetes mellitus with or without diabetic neuropathy.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mishima Hideyuki
Organization Aichi Medical University
Division name Cancer Center
Zip code
Address 1-1, Yazakokarimata, Nagakute, Aichi
TEL 0561-62-3311
Email hmishima@aichi-med-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chigusa Abe
Organization Epidemiological and Clinical research Information Network (ECRIN)
Division name Data Center
Zip code
Address 21-7 Shogoinn Sakyo-ku, Kyoto
TEL 075-762-1227
Homepage URL
Email chigusa.abe@ecrin.or.jp

Sponsor
Institute NPO Epidemiological and Clinical Research Information Network (ECRIN)
Institute
Department

Funding Source
Organization NPO Epidemiological and Clinical Research Information Network (ECRIN)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2010 Year 10 Month 01 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
2010 Year 08 Month 24 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
2012 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 09 Month 28 Day
Last modified on
2018 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005135

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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