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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006951


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name