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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017288
Receipt No. R000020057
Scientific Title Efficacy of enteral nutrition enriched with eicosapentaenoic acid (Prosure) for the treatment of chemoradiotherapy for head and neck cancer
Date of disclosure of the study information 2015/04/27
Last modified on 2018/11/28

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Basic information
Public title Efficacy of enteral nutrition enriched with eicosapentaenoic acid (Prosure) for the treatment of chemoradiotherapy for head and neck cancer
Acronym Efficacy of enteral nutrition enriched with eicosapentaenoic acid (Prosure) for the treatment of chemoradiotherapy for head and neck cancer
Scientific Title Efficacy of enteral nutrition enriched with eicosapentaenoic acid (Prosure) for the treatment of chemoradiotherapy for head and neck cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Satoshi Fukuda
Organization Hokkaido University Graduate School of Medicine
Division name otolaryngology-head and neck surgery
Zip code
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
1st name
Middle name
Last name Takatsugu Mizumachi
Organization Hokkaido University Hospital
Division name otorhinolaryngology
Zip code
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)

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 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

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 Completed
Date of protocol fixation
2013 Year 10 Month 21 Day
Date of IRB
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

Other
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

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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