UMIN-CTR Clinical Trial

Basic information
Public title	Prophylactic effect of rikkunshito on bodyweight loss accompanied with anorexia after esophagectomy
Acronym	Effect of rikkunshito on anorexia after esophagectomy
Scientific Title	Prophylactic effect of rikkunshito on bodyweight loss accompanied with anorexia after esophagectomy
Scientific Title:Acronym	Effect of rikkunshito on anorexia after esophagectomy
Region	Japan

Condition
Condition	esophageal cancer
Classification by specialty	Surgery in general
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the prophylactic effect of rikkunshito on bodyweight loss and malnutrition accompanied with anorexia after esophagectomy
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change of bodyweight
Key secondary outcomes	BMI, QOL serum albumin, prealbumin

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	rikkunshi-to
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1)patients with esophagealcancer who undergo esophagectomy with gastric conduit 2)an age of 20 years or older, 80 years or younger 3)PS(ECOG):0-2 4) written informed consent
Key exclusion criteria	1)serious comcomitant diseases 2)multiple primary cancer 3)impossible oral intake 4)adiminstration of Kampo within two weeks
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masaki Nakamura
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code
Address	Kimiidera, Wakayama, Japan
TEL	073-441-0613
Email	twins@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Masaki Nakamura
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code
Address	Kimiidera, Wakayama, Japan
TEL	073-441-0613
Homepage URL
Email	twins@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
Institute
Department

Funding Source
Organization	Tsumura
Organization
Division
Category of Funding Organization	Profit organization
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	2011 Year 12 Month 28 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	No longer recruiting
Date of protocol fixation	2011 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date	2011 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 12 Month 27 Day
Last modified on	2019 Year 07 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008222