UMIN-CTR Clinical Trial

Basic information
Public title	Effect of Goreisan in preventing or reducing diarrhea in patients receiving concurrent chemoradiotherapy for cervical cancer
Acronym	Effect of Goreisan in preventing or reducing chemoradiation-induced diarrhea
Scientific Title	Effect of Goreisan in preventing or reducing diarrhea in patients receiving concurrent chemoradiotherapy for cervical cancer
Scientific Title:Acronym	Effect of Goreisan in preventing or reducing chemoradiation-induced diarrhea
Region	Japan

Condition
Condition	cervical cancer
Classification by specialty	Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to investigate the efficacy and safety of Goreisan for preventing diarrhea during radiation therapy in patients with cervical cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Occurrence rate of >grade 2 diarrhea as measured by the Common Terminology Criteria for Adverse Events v4.0.
Key secondary outcomes	1) Protection period of diarrhea (total treatment duration - total days of >grade 2 diarrhea / total treatment duration); 2) Time to the first occurrence of >grade 2 diarrhea from the first day of treatment; 3) Adverse effects; 4) Frequency of diarrhea and transition of the grade of diarrhea.

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	Goreisan 7.5g per day
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	20 years-old <
Age-upper limit	70 years-old >
Gender	Female
Key inclusion criteria	1) Histologically confirmed uterine cervical cancer of clinical stage IB2-IVa in whom cisplatin-based CCRT was planned as both primary and adjuvant treatments 2) Age >20 years, <75 years; 3) Performance status =<2; 4) With written informed consent obtained before participation; 5) No prior radiother
Key exclusion criteria	1) Inflammatory bowel disease such as Crohn disease and ulcerative colitis 2) Severe hepatic dysfunction (aspartate aminotransferase or alanine aminotransferase >=100 U/L) 3) Severe renal dysfunction (serum creatinine >=1.5 mg/dL or blood urea nitrogen >=25 mg/dL) 4) Mental illness that may require the administration of antipsychotics, and dementia 5) Current use of other oriental medicine 6) A history of the hypersensitivity that is serious for the study medicine, or drug allergy 7) Any case that the chief physician judges to be inadequate.
Target sample size	40

Research contact person
Last name of lead principal investigator	1st name AKIRA Middle name Last name Mitsuhashi
Organization	Graduate School of Medicine, Chiba University
Division name	Reproductive Medicine
Zip code	260-8670
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL	043-222-7171
Email	antira@faculty.chiba-u.jp

Public contact
1st name of contact person	1st name Sinsuke Middle name Last name Hanawa
Organization	Chiba University Hospital
Division name	Gynecology
Zip code	260-8670
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
TEL	043-222-7171
Homepage URL
Email	hanawa-shinsuke@chiba-u.jp

Sponsor
Institute	Chiba University Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Chiba University Hospital Institutional Review Board
Address	1-8-1 Inohana, Chuo-ku, Chiba 260-8670, Japan
Tel	043-222-7171
Email	hanaoka.hideki@faculty.chiba-u.jp

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	2015 Year 03 Month 02 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	Terminated
Date of protocol fixation	2014 Year 10 Month 19 Day
Date of IRB	2014 Year 12 Month 17 Day
Anticipated trial start date	2015 Year 03 Month 02 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 03 Month 02 Day
Last modified on	2019 Year 04 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000019357