UMIN-CTR Clinical Trial

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
Email	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
Email	ykitamura@tokushima-u.ac.jp

Sponsor
Institute	University of Tokushima
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006951