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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003991
Receipt No. R000004801
Scientific Title The effect of L-glutamine on chemoradiotherapy induced oral mucositis in patients with head and neck cancer
Date of disclosure of the study information 2010/08/03
Last modified on 2010/08/03

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Basic information
Public title The effect of L-glutamine on chemoradiotherapy induced oral mucositis in patients with head and neck cancer
Acronym The effect of L-glutamine on chemoradiotherapy induced oral mucositis in patients with head and neck cancer
Scientific Title The effect of L-glutamine on chemoradiotherapy induced oral mucositis in patients with head and neck cancer
Scientific Title:Acronym The effect of L-glutamine on chemoradiotherapy induced oral mucositis in patients with head and neck cancer
Region
Japan

Condition
Condition head and neck cancer
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of L-glutamine on chemoradiotherapy induced oral mucositis in patients with head and neck cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes to assess the severity of oral mucositis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 oral L-glutamine administration during the days of chemoradiotherapy
Interventions/Control_2 oral placebo administration during the days of chemoradiotherapy
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

Not applicable
Gender Male and Female
Key inclusion criteria 1.more than 20 years of age
2.scheduled to receive chemoradiotherapy
3.recovered from previous chemotherapy
and radiotherapy toxicities
4.informed written concent
Key exclusion criteria 1.major impairment of liver and/or
kidney
2.uncontrolled diabetes mellitus
3.receiving any other treatment
specifically targeting oral mucositis
4.active mouth or gingival sore
5.pregnant,lactating, or at risk of
pregnancy
6.allergic to L-glutamine
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshinori Ito
Organization Osaka University Graduate School of Medicine
Division name Department of Complementary & Alterative Medicine
Zip code
Address 2-2 Yamadaoka, Suita, Osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka University Graduate School of Medicine
Division name Department of Complementary & Alterative Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Department of Complementary & Alterative Medicine at Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2010 Year 08 Month 03 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 Enrolling by invitation
Date of protocol fixation
2009 Year 10 Month 16 Day
Date of IRB
Anticipated trial start date
2010 Year 08 Month 01 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
2010 Year 08 Month 03 Day
Last modified on
2010 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004801

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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