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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024403
Receipt No. R000028086
Official scientific title of the study 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 2016/12/22

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Basic information
Official scientific title of the study Reduce the acute adverse event of head and neck radiotherapy by an amino acid: prospective clinical trials
Title of the study (Brief title) 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 Takashi Nakano
Organization Gunma university graduate school of medicine
Division name Radiation oncology
Address 3-39-15 showa-machi maebashi gunma
TEL 0272208378
Email tnakano@gunma-u.ac.jp

Public contact
Name of contact person Atsushi Musha
Organization Gunma university graduate school of medicine
Division name Radiation oncology
Address 3-39-15 showa-machi maebashi gunma
TEL 0272208378
Homepage URL
Email musha@gunma-u.ac.jp

Sponsor
Institute Gunma university graduate school of medicine
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2016 Year 10 Month 13 Day
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2016 Year 10 Month 14 Day
Last modified on
2016 Year 12 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028086

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
Registered date Registrant File name


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