UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Double-Blind , Placebo-Controlled Randomized Phase II Study of Hangeshashinto for Prevention of Oral Mucositis in Colorectal Cancer Patients Receiving Chemotherapy (HANGESHA-C Study).
Title of the study (Brief title)	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	Mishima Hideyuki
Organization	Aichi Medical University
Division name	Cancer Center
Address	1-1, Yazakokarimata, Nagakute, Aichi
TEL	0561-62-3311
Email	hmishima@aichi-med-u.ac.jp

Public contact
Name of contact person	Chigusa Abe
Organization	Epidemiological and Clinical research Information Network (ECRIN)
Division name	Data Center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 08 Month 24 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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