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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000021755
Receipt No. R000025090
Scientific Title Effect of EPA on chemoradiotherapy in local advvanced head and neck cancer
Date of disclosure of the study information 2016/04/03
Last modified on 2019/04/06

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Basic information
Public title Effect of EPA on chemoradiotherapy in local advvanced head and neck cancer
Acronym Effect of EPA on chemoradiotherapy in local advvanced head and neck cancer
Scientific Title Effect of EPA on chemoradiotherapy in local advvanced head and neck cancer
Scientific Title:Acronym Effect of EPA on chemoradiotherapy in local advvanced head and neck cancer
Region
Japan

Condition
Condition lacal advanced head and neck squamous cell carcinoma
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We evaluate the effect of eicosapentaenoic acid(EPA) on chemoradiotherapy in local advanced head and neck squamous carcinoma.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II,III

Assessment
Primary outcomes Transition of nutritional status and inflammatory response
Key secondary outcomes Treatment completion rate, Treatment completion dates, Length of stay in hospital, Progression-free survival, Overall survival

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 The patient starts the oral ingestion of half-digested state nutritional supplement(300 kcal equivalent) with/without EPA from the start date of chemical radiation therapy every day.
Interventions/Control_2 The patient requires calorie intake maintenance of the day by tube feeding including PEG in case of difficlt of oral intake.
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Histologically proven squamous cell carcinoma in resected specimen
2) Primary lesion located at oropharynx, hypopharynx, or larynx
3) Pathological stage III, IVA or IVB
4) Enable to PEG manufacture
5) No prior radiation therapy, chemotherapy, nor hormonal therapy
6) No fistule formation at the primary tumor and cervical lymph nodes
7) No distant metastasis
8) ECOG performance status (PS) of 0 or 1
9) Adequate organ functions
10)Written informed consent
Key exclusion criteria 1) Women during pregnancy, possible pregnancy, or breast-feeding
2) Simultaneous or metachronous (within 3 months) double cancers
3) Psychiatric disease
4) Patients unsuitable for registration by decision of physicians
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Ichiro
Middle name
Last name Ota
Organization Nara Medical University
Division name Otolaryngology-Head and Neck Surgery
Zip code 634-8522
Address 840 Shijo-cho Kashihara Nara, JAPAN
TEL 0744-22-3051
Email iota@naramed-u.ac.jp

Public contact
Name of contact person
1st name Ichiro
Middle name
Last name Ota
Organization Nara Medical University
Division name Otolaryngology-Head and Neck Surgery
Zip code 6348522
Address 840 Shijo-cho Kashihara Nara, JAPAN
TEL 0744-22-3051
Homepage URL
Email iota@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization Nara Medical University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nara Medical University Ethics Committee
Address 840 Shijo-cho Kashihara Nara, JAPAN
Tel 0744-22-3051
Email icats@naramed-u.ac.jp

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 奈良県立医科大学

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 03 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 No longer recruiting
Date of protocol fixation
2013 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 20 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2018 Year 03 Month 31 Day
Date analysis concluded
2018 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 04 Month 03 Day
Last modified on
2019 Year 04 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025090

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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