UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009298 |
|---|---|
| Receipt number | R000010921 |
| Scientific Title | Phase II study of elental for chemotherapy induced mucositis oral and nutritional disturbance |
| Date of disclosure of the study information | 2012/11/09 |
| Last modified on | 2013/11/09 09:17:42 |
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Basic information
Public title
Phase II study of elental for chemotherapy induced mucositis oral and nutritional disturbance
Acronym
Phase II study of elental for chemotherapy induced mucositis oral and nutritional disturbance
Scientific Title
Phase II study of elental for chemotherapy induced mucositis oral and nutritional disturbance
Scientific Title:Acronym
Phase II study of elental for chemotherapy induced mucositis oral and nutritional disturbance
Region
| Japan |
Condition
Condition
cancer chemotherapy induced mucositis oral and nutritional disturbance
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of elental for cancer chemotherapy induced mucositis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
response rate of oral mucositis
Key secondary outcomes
persistency of elental
efficacy for nutrition
change of body weight
change of oral intake
safety
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
elental
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)having cancer chemotherapy induced oral mucosits
2)Performance status(ECOG) 0 or 1
3)age 20 years over
4)life expetancy > 3months
5)adequate organ function
6)written informed consent
Key exclusion criteria
1)severe symptom with cancer
2)difficult to take elental due to other gastro intestinal symptoms
3)recieve other treatment for oral mucositis
4)physician judged inadequate
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | masato nakamura |
Organization
Aizawa Hospital
Division name
Aizawa comprehensive cancer center
Zip code
Address
2-5-1 Honjo, Matsumoto city,. Nagano
TEL
0263-33-8600
geka-dr7@ai-hosp.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | masato nakamura |
Organization
Aizawa Hospital
Division name
Aizawa comprehensive cancer center
Zip code
Address
2-5-1 Honjo, Matsumoto city,. Nagano
TEL
0263-33-8600
Homepage URL
geka-dr7@ai-hosp.or.jp
Sponsor or person
Institute
Aizawa Hospital
Institute
Department
Personal name
Funding Source
Organization
Aizawa Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2012 | Year | 11 | Month | 09 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 11 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 09 | 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
| 2012 | Year | 11 | Month | 09 | Day |
Last modified on
| 2013 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010921
