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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000016240
Receipt No. R000018846
Scientific Title Efficacy of elemental diet on chemo-radiatiotherapy for patients with oral cancer
Date of disclosure of the study information 2015/02/12
Last modified on 2020/07/21

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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/ctr_e/ctr_view.cgi?recptno=R000018846

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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