UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study on reduction of mucous membrane inflammation by the nutritional supplement Elental in concurrent chemoradiotherapy for head and neck squamous cell carcinoma
Title of the study (Brief title)	Reduction of mucous membrane inflammation by Elental in concurrent chemoradiotherapy
Region	Japan

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

Objectives
Narrative objectives1	Concurrent chemoradiotherapy (CCRT) is effective in treating head and neck cancer, but adverse effects, ie, inflammation of oral and pharyngeal mucosa, are common. A treatment to prevent such inflammation during CCRT has not been established. The nutritional supplement "Medicine Combined With Elental" (hereafter Elental) inhibits mucous membrane inflammation via the action of amino acids (ie, glutamine, histidine), and may thus be useful in reducing such inflammation during cancer treatment. We examined the effect of Elental on oral/pharyngeal mucosal inflammation during CCRT for head and neck cancer.
Basic objectives2	Pharmacodynamics
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	CTCAE score for inflammation of oral/pharyngeal mucosa
Key secondary outcomes	Rate of CCRT completion, duration of cessation of oral-intake, duration and dosage of opioids, days of Elental administration, days of hospitalization after CCRT, body weight, total protein, albumin decrease (%)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is considered as adjustment factor in dynamic allocation.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Elental (1 pack per day) from day 1 to 7 days after end of radiation therapy
Interventions/Control_2	No administration of Elental
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	1) Pathologic or cytologic diagnosis of head and neck squamous cell carcinoma treated with radical CCRT, ie, 3 courses of CDDP every 3 weeks plus whole-neck irradiation, including bilateral levels II-IV 2) Initial chemotherapy 3) Measurable or evaluable lesions 4) Performance status (PS) 0-1 5) Age 20-75 years 6) No complications that might affect treatment 7) No other cancer 8) Normal liver, kidney, and marrow function White blood cells >3,000/mm3 Neutrophils >1,500/mm3 Blood platelet >100,000mm3 Total bilirubin normal AST and ALT normal Creatinine normal Ccr or eGFR >60 ml/min 9) Written informed consent
Key exclusion criteria	1) Past history of serious drug hypersensitivity 2) Presence of other cancer 3) Clinically problematic infectious disease 4) >1 complication that might affect treatment 5) Nonradical treatment indicated 6) Pregnant or nursing women and those with the possibility of pregnancy 7) Mental or neurologic disease that might affect participation 8) Abnormality in amino acid metabolism 9) Severe diabetes or possibility of glucose metabolism abnormality due to high-dose steroid treatment 10) Participation judged by physician to be inadvisable
Target sample size	50

Research contact person
Name of lead principal investigator	Hiroshi Matsuyama
Organization	Niigata University, Faculty of Medicine
Division name	Otolaryngology, Head and Neck
Address	1-757 Asahimachi-dori, Chuo-ku, Niigata-shi, Niigata-ken
TEL	+81-25-227-2306
Email	matsuhiroshi@med.niigata-u.ac.jp

Public contact
Name of contact person	Hiroshi Matsuyama
Organization	Niigata University, Faculty of Medicine
Division name	Otolaryngology, Head and Neck
Address	1-757 Asahimachi-dori, Chuo-ku, Niigata-shi, Niigata-ken
TEL	+81-25-227-2306
Homepage URL
Email	matsuhiroshi@med.niigata-u.ac.jp

Sponsor
Institute	Niigata University, Faculty of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Niigata Cancer Center Hospital Niigata City General Hospital Nagaoka Red Cross Hospital
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	新潟大学医歯学総合病院（新潟県） 新潟県立がんセンター新潟病院（新潟県） 新潟市民病院（新潟県） 長岡赤十字病院（新潟県）

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 04 Month 01 Day
Anticipated trial start date	2015 Year 03 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 08 Month 31 Day
Date trial data considered complete	2017 Year 08 Month 31 Day
Date analysis concluded	2017 Year 08 Month 31 Day

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 03 Month 31 Day
Last modified on	2018 Year 04 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012135