UMIN-CTR Clinical Trial

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
Email	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
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)

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028086