UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016240 |
|---|---|
| Receipt number | R000018846 |
| Scientific Title | Efficacy of elemental diet on chemo-radiatiotherapy for patients with oral cancer |
| Date of disclosure of the study information | 2015/02/12 |
| Last modified on | 2020/07/21 09:48:33 |
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Basic information
Public title
Efficacy of elemental diet on chemo-radiatiotherapy for patients with oral cancer
Acronym
Efficacy of elemental diet on chemo-radiatiotherapy
Scientific Title
Efficacy of elemental diet on chemo-radiatiotherapy for patients with oral cancer
Scientific Title:Acronym
Efficacy of elemental diet on chemo-radiatiotherapy
Region
| Japan |
Condition
Condition
oral cancer
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The present study was designed to evaluate the preventive effects of elemental diet, Elental on radiotherapy- or chemoradiotherapy-induced mucositis in patients with oral cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We compared the efficacy of Elental for the change of oral mucositis (size, reddish and pain) between CRT and RT alone.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Elental administration group one bottle per day every day during radiation
Interventions/Control_2
Elental non-administration group
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients who bear below criteria.
1) The patient who receive chemotherapy and/or radiotherapy against oral cancer.
2) The patient who is more than twenty years old when the patient obtained informed consent.
3) The patient who obtain informed consent.
Key exclusion criteria
The patients who bear below criteria.
1)The patients who has shown intolerance to the component of Elental.
2)The diabetic patients who need to inject insulin.
3)The patients who has disorders of amino acid metabolism.
4)The patients who is in pregnancy.
5)The patients who is not suitable for this clinical study by doctors.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshiya |
| Middle name | |
| Last name | Ueyama |
Organization
Yamaguchi university school of medicine
Division name
Oral and maxillofacial surgery
Zip code
755-8505
Address
1-1-1, minamikogusi, Ube, Yamaguchi
TEL
0836-22-2297
uyoshiya@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Koji |
| Middle name | |
| Last name | Harada |
Organization
Yamaguchi university school of medicine
Division name
Oral and maxillofacial surgery
Zip code
755-8505
Address
1-1-1, minamikogusi, Ube, Yamaguchi
TEL
0836-22-2299
Homepage URL
harako@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi university school of medicine
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto drug company
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
Yamaguchi university school of medicine clinical research center
Address
1-1-1, minamikogusi, Ube, Yamaguchi
Tel
0836-22-2428
clin_res@yamaguchi-u.ac.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 | 02 | Month | 12 | 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
| 2015 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 02 | Month | 12 | 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
| 2015 | Year | 01 | Month | 16 | Day |
Last modified on
| 2020 | Year | 07 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018846
| 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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| Registered date | File name |
