UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022709 |
|---|---|
| Receipt number | R000026165 |
| Scientific Title | Clinical research on effectiveness of amino acids supplementation on the severity of mucositis during chemoradiotherapy in oral cancer patients. |
| Date of disclosure of the study information | 2016/06/13 |
| Last modified on | 2023/12/19 09:35:21 |
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Basic information
Public title
Clinical research on effectiveness of amino acids supplementation on the severity of mucositis during chemoradiotherapy in oral cancer patients.
Acronym
Clinical research on effectiveness of amino acids supplementation on the severity of mucositis during chemoradiotherapy in oral cancer patients.
Scientific Title
Clinical research on effectiveness of amino acids supplementation on the severity of mucositis during chemoradiotherapy in oral cancer patients.
Scientific Title:Acronym
Clinical research on effectiveness of amino acids supplementation on the severity of mucositis during chemoradiotherapy in oral cancer patients.
Region
| Japan |
Condition
Condition
Oral cancer
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of amino acids supplementation on the severity of mucositis and other adverse events during chemoradiotherapy in oral cancer patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The severity of mucositis
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is considered as a block.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Test foods containing of amino acids is administered by orally or gavage, twice daily (morning and evening) from the start day of the chemotherapy to 14 days after the chemoradiotherapy.
Interventions/Control_2
Placebo is administered by orally or gavage, twice daily (morning and evening) from the start day of the chemotherapy to 14 days after the chemoradiotherapy
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients (men and women aged from 20 to 90 years old) undergo chemoradiotherapy as preoperative treatment
2) Patients from whom written informed consent is obtained
3) Patients deemed suitable by the principal investigator, investigators of the research project or investigators of the sub institution.
Key exclusion criteria
1) Patients who have the severe complications
2) Patients who have the history of severe hypersensitivity
3) Patients who have the history of aminoacidopathy
4) Patients included in other clinical studies within 3 months or in process.
5) Patients with other conditions whom principal investigator, the investigator of this project and the investigator of sub institution consider inadequate such as routine users of similar food (e.g. amino acid supplement)
6) Patients who have renal dysfunction that creatinine clearance are less than 30 ml/min
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Nakamura |
Organization
Division of Maxillofacial Diagnostic and Surgical Sciences, Faculty of Dental Science, Kyushu University
Division name
Section of Oral and Maxillofacial Oncology
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-6447
seiji@dent.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazunari |
| Middle name | |
| Last name | Oobu |
Organization
Kyushu University Hospital
Division name
Department of Oral Surgery
Zip code
812-8582
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, Japan
TEL
092-642-6447
Homepage URL
kazunari@dent.kyushu-u.ac.jp
Sponsor or person
Institute
KYOWA HAKKO BIO CO., LTD
Institute
Department
Personal name
Funding Source
Organization
KYOWA HAKKO BIO CO., LTD
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
Ethics committee of Kyushu University Hospital
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka, 812-8582, Japan
Tel
092-642-5774
byskenkyu@jimu.kyushu-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
九州大学病院（福岡県）、鹿児島大学医学部・歯学部附属病院（鹿児島県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 06 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 04 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 30 | 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
| 2016 | Year | 06 | Month | 12 | Day |
Last modified on
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026165
