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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010747
Receipt No. R000012116
Scientific Title Randomized cross-over trial of rikkunshito for emesis and anorexia in patients receiving chemotherapy for esophageal cancer
Date of disclosure of the study information 2013/05/17
Last modified on 2019/08/01

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Basic information
Public title Randomized cross-over trial of rikkunshito for emesis and anorexia in patients receiving chemotherapy for esophageal cancer
Acronym The efficacy of rikkunshito on emesis and anorexia in patients receiving chemotherapy for esophageal cancer
Scientific Title Randomized cross-over trial of rikkunshito for emesis and anorexia in patients receiving chemotherapy for esophageal cancer
Scientific Title:Acronym The efficacy of rikkunshito on emesis and anorexia in patients receiving chemotherapy for esophageal cancer
Region
Japan

Condition
Condition esophageal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of rikkunshito on emesis and anorexia in patients receiving chemotherapy involving cisplatin for esophageal cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Food intake
(rate of decreased calorie intake (%))
Key secondary outcomes 1)The number of times that patients could not eat a meal at all.
2) VAS of appetite
3) QOL score for emesis (Functional Living index Emesis(FLIE) scale)
4) QOL score (EORTC scale)
5) Grade of CTCAE
6) Plasma ghrelin level(acyl-ghrelin and desacyl-ghrelin)
7) Adverse events
8) Side effects

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of rikkunshito
(2.5g t.i.d) before meals for 2weeks
Interventions/Control_2 standard 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
20 years-old <=
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria Selection criterion at enrollment

1)Patients who were diagnosed as esophageal cancer according to pathology and cytology
2)Patients who will recieve chemotherapy involving cisplatin more than once.
3)Performance status is 0 to 1
4)Gender: no specification
5)Age>20,<75
6)Hospital admission or outpatient department
7)Adequate organ function
8)Agreement to sigh an informed consent
Key exclusion criteria 1)Patients who underwent gastrectomy
2)Patients for whom oral administration was impossible
3)Patients who have another active malignancy
4)Patients with cachexia
5)Patients who does not have an estimated life expectancy of more 3 month
6)Patients who were administered durgs prohibited or KAMPO medicine 2 weeks before entry
7)Drug allergy for Rikkunshito
8)Patients who are pregnant,considering pregnancy or lactaing
9)Patients who are regarded in eligible by the doctor who participates in this study
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Morihito Okada
Organization Hiroshima University
Division name Surgical Oncology
Zip code
Address 1-2-3 Kasumi,Minami-ku,Hiroshima,Hiroshima
TEL 082-257-5869
Email morihito@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomoharu Yoshiya
Organization Hiroshima University
Division name Surgical Oncology
Zip code
Address 1-2-3 Kasumi,Minami-ku,Hiroshima,Hiroshima
TEL 082-257-5869
Homepage URL
Email hidekatsu115@yahoo.co.jp

Sponsor
Institute Hiroshima University
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization None

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
2013 Year 05 Month 17 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 Completed
Date of protocol fixation
2013 Year 05 Month 15 Day
Date of IRB
2013 Year 05 Month 15 Day
Anticipated trial start date
2013 Year 06 Month 01 Day
Last follow-up date
2016 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 05 Month 17 Day
Last modified on
2019 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012116

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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