UMIN-CTR Clinical Trial

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
Email	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
Email	harako@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi university school of medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018846