UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005885 |
|---|---|
| Receipt number | R000006951 |
| Scientific Title | Effects of monosodium glutamate (MSG) on taste function, expression of taste receptor mRNA of tongue and malnutorition in patients with head and neck cancer after chemotherapy. |
| Date of disclosure of the study information | 2011/06/29 |
| Last modified on | 2022/03/04 11:05:17 |
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Basic information
Public title
Effects of monosodium glutamate (MSG) on taste function, expression of taste receptor mRNA of tongue and malnutorition in patients with head and neck cancer after chemotherapy.
Acronym
Effects of MSG on taste, taste receptor gene expression and malnutorition in patients with head and neck cancer.
Scientific Title
Effects of monosodium glutamate (MSG) on taste function, expression of taste receptor mRNA of tongue and malnutorition in patients with head and neck cancer after chemotherapy.
Scientific Title:Acronym
Effects of MSG on taste, taste receptor gene expression and malnutorition 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
In the present study, an attempt was made to examine effects of monosodium glutamate (MSG) on taste function, the expression of taste receptor mRNA of the tongue and malnutrition in patients with head and neck cancer after chemotherapy. For this purpose, we test the function of taste including umami using taste disc method, measure their expression of umami receptor mRNA of the tongue using real-time PCR and evaluate their nutrition status by measuring their body weight, serum levels of total protein and albumin and QOL concerning about nutrition.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The function of taste including umami and the expression of taste receptor mRNA of the tongue
Key secondary outcomes
Body weight, levels of total protein and albumin in the serum and QOL concerning about nutrition.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Self-supplementation of MSG on hospital meal
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients with head and neck cancer that is pathologically diagnosed complaining of chemotherapy-induced poor appetite of which grade over I estimated by Common Terminology Criteria for Adverse Events (version 4).
Key exclusion criteria
1) Patients who have ever suffered from adverse event of MSG.
2) Patients who was excluded by investigators.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Kitamura |
Organization
University of Tokushima School of Medicine
Division name
Department of Otolaryngology
Zip code
770-8503
Address
3-18-15
TEL
088-633-7169
ykitamura@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Kitamura |
Organization
University of Tokushima School of Medicine
Division name
Department of Otolaryngology
Zip code
770-8503
Address
3-18-15 Kuramoto, Tokushima 770-8503, Japan
TEL
088-633-7169
Homepage URL
ykitamura@tokushima-u.ac.jp
Sponsor or person
Institute
University of Tokushima
Institute
Department
Personal name
Funding Source
Organization
University of Tokushima
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
Committees for Medical Ethics of Tokushima University Hospital
Address
Kuramoto, Tokushima, Japan
Tel
088-633-9294
first-ec@clin.med.tokushima-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
| 2011 | Year | 06 | Month | 29 | 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
| 2011 | Year | 06 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2011 | 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
| 2011 | Year | 06 | Month | 29 | Day |
Last modified on
| 2022 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006951
