UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of L-glutamine on oral mucositis induced by chemoradiotherapy in patients with head and neck cancer.
Title of the study (Brief title)	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	Mika Kurihara
Organization	Shiga University of Medical Science Hospital
Division name	Clinical nutrition
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	Mai Inoue
Organization	Shiga University of Medical Science Hospital
Division name	Clinical nutrition
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)

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

Progress
Recruitment status	Recruiting
Date of protocol fixation	2016 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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