UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024403 |
|---|---|
| Receipt number | R000028086 |
| Scientific Title | Reduce the acute adverse event of head and neck radiotherapy by an amino acid: prospective clinical trials |
| Date of disclosure of the study information | 2016/10/14 |
| Last modified on | 2022/04/19 11:24:35 |
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Basic information
Public title
Reduce the acute adverse event of head and neck radiotherapy by an amino acid: prospective clinical trials
Acronym
Reduce the acute adverse event of head and neck radiotherapy by an amino acid: prospective clinical trials
Scientific Title
Reduce the acute adverse event of head and neck radiotherapy by an amino acid: prospective clinical trials
Scientific Title:Acronym
Reduce the acute adverse event of head and neck radiotherapy by an amino acid: prospective clinical trials
Region
| Japan |
Condition
Condition
head and neck cancer
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We analyze the occurrence of adverse event situation in the patients who received radiotherapy (carbon ion radiotherapy, X-rays) that gave an amino acid for head and neck cancer prospectively.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Dermatitis / mucositis
(From beginning of an amino acid to four weeks after end of treatment.)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Abound (amino acid)
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Pathological type is head and neck cancer.
2) Will irradiation patients.
3) 18 years-old <=.
4) Performance status is 0-2.
5) The notice of the name of disease is accomplished and the person has ability for agreement.
Key exclusion criteria
1) Irradiation history
2) After the treatment to other sites tumor for four weeks.
3) Infections
4) Serious complication
5) Cessation of radiation therapy
6) And so on
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Nakano |
Organization
Gunma university graduate school of medicine
Division name
Radiation oncology
Zip code
3718511
Address
3-39-15 showa-machi maebashi gunma
TEL
0272208378
tnakano@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Musha |
Organization
Gunma university graduate school of medicine
Division name
Radiation oncology
Zip code
3718511
Address
3-39-15 showa-machi maebashi gunma
TEL
0272208378
Homepage URL
musha@gunma-u.ac.jp
Sponsor or person
Institute
Gunma university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Gunma university graduate school of medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gunma University Hospital Clinical Research Review Board
Address
3-39-15 Showa-machi, Maebashi, Gunma
Tel
027-220-8740
ciru_hitotaisho-irb@ml.gunma-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
| 2016 | Year | 10 | Month | 14 | 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
| 2016 | Year | 10 | Month | 13 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 10 | Month | 14 | Day |
Last modified on
| 2022 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028086
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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