UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003991 |
|---|---|
| Receipt number | 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 20:29:32 |
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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
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
Sponsor or person
Institute
Department of Complementary & Alterative Medicine at Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004801
