UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010747 |
|---|---|
| Receipt number | 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 19:40:10 |
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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
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
hidekatsu115@yahoo.co.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012116
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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