UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of enteral nutrition enriched with eicosapentaenoic acid (Prosure) for the treatment of chemoradiotherapy for head and neck cancer
Title of the study (Brief title)	Efficacy of enteral nutrition enriched with eicosapentaenoic acid (Prosure) for the treatment of chemoradiotherapy for head and neck cancer
Region	Japan

Condition
Condition	oropharyngeal carcinoma hypopharyngeal carcinoma
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate of the efficacy of enteral nutrition enriched with eicosapentaenoic acid (Prosure) for the treatment of chemoradiotherapy for head and neck cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the maximam body weight loss during the treatment
Key secondary outcomes	the ratio of the patients with mucositis and dermatitis during the treatment

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	enteral nutrition enriched with eicosapentaenoic acid (Prosure)
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	The patients with oropharyngeal and hypopharyngeal carcinoma treated with chemoradiotherapy using concomitant cisplatin
Key exclusion criteria	The patients with severe comobility
Target sample size	17

Research contact person
Name of lead principal investigator	Satoshi Fukuda
Organization	Hokkaido University Graduate School of Medicine
Division name	otolaryngology-head and neck surgery
Address	Kita 15-jo Nishi 7-chome,Kita-ku,Sapporo
TEL	011-706-5958
Email	safukuda@med.hokudai.ac.jp

Public contact
Name of contact person	Takatsugu Mizumachi
Organization	Hokkaido University Hospital
Division name	otorhinolaryngology
Address	Kita 14-jo Nishi 5-chome,Kita-ku,Sapporo
TEL	011-706-5958
Homepage URL
Email	mizumati@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital otorhinolaryngology
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
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	北海道大学病院（北海道）

Other administrative information
Date of disclosure of the study information	2015 Year 04 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 21 Day
Anticipated trial start date	2013 Year 10 Month 21 Day
Last follow-up date	2015 Year 11 Month 30 Day
Date of closure to data entry	2015 Year 11 Month 30 Day
Date trial data considered complete	2015 Year 11 Month 30 Day
Date analysis concluded	2016 Year 11 Month 30 Day

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

Management information
Registered date	2015 Year 04 Month 27 Day
Last modified on	2018 Year 11 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020057