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UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000024045
Receipt No. R000027690
Scientific Title The effect of L-glutamine on oral mucositis induced by chemoradiotherapy in patients with head and neck cancer.
Date of disclosure of the study information 2016/10/01
Last modified on 2016/09/14

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

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

Objectives
Narrative objectives1 To evaluate of efficacy of enteral supplementation product enriched with L-glutamine in patients with head and neck cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes CTCAE score for inflammation of oral pharyngeal mucosa.
Key secondary outcomes 1)Physical measurement
Body weight, Lean body weight, body fat mass, Grip strength
2)Digestive symptom
oral mucositis, taste disturbance, diarrhea, appetite
3)score of Quality of life(QOL)
EORT-QLQ-C30
4)Blood test
Alb,TP,PA,RBP,serum diamine oxidase activity,IL-6,active ghrelin
5)Amount of total Energy
by oral feeding, enteral feeding, parenteral nutrition
6)Duration and dosage of opioid.
7)Rate of CRT completion.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants 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 L-glutamine group: L-glutamine(1-3 pack per day) from 4days before to end of CRT.
Interventions/Control_2 Control group: Placebo(1-3 pack per day) from 4days before to end of CRT.
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) Aged >= 20
2) Patients with head and neck cancer.
3) Patients who receive chemoradiotherapy.
4) Recovered from previous chemotherapy and radiotherapy toxicities.
5) Patients who obtained the consent.
Key exclusion criteria 1)Unable intake glutamine formulations per oral or per enteral tube.
2)major impairment of liver
3)major impairment of kidney
4)allergic to L-glutamine
5)pregnant,lactating
6)presence of other cancer under treatment.
7)severe psychosis or psychiatric symptoms
8)paticipation judged by physician to be inadvisable
9)paticipation not taking opioids
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mika Kurihara
Organization Shiga University of Medical Science Hospital
Division name Clinical nutrition
Zip code
Address Seta Tsukinowa-cho, Otsu-city, Shiga, Japan 520-2192
TEL 077-548-2519
Email kuri@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mai Inoue
Organization Shiga University of Medical Science Hospital
Division name Clinical nutrition
Zip code
Address Seta Tsukinowa-cho, Otsu-city, Shiga, Japan 520-2192
TEL 077-548-2519
Homepage URL
Email maiapril@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science Hospital
Institute
Department

Funding Source
Organization Aido Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
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
2016 Year 10 Month 01 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
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 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
2016 Year 09 Month 14 Day
Last modified on
2016 Year 09 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027690

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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