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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007844
Receipt No. R000009244
Scientific Title Evaluation of effects of oral nutrition enriched with Eicosapentaenoic acid(EPA) in patients underwent neoadjuvant chemo therapy for head and neck cancer.
Date of disclosure of the study information 2012/05/01
Last modified on 2013/04/27

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Basic information
Public title Evaluation of effects of oral nutrition enriched with Eicosapentaenoic acid(EPA) in patients underwent neoadjuvant chemo therapy for head and neck cancer.
Acronym Evaluation of effects of oral nutrition enriched with Eicosapentaenoic acid(EPA) in patients underwent neoadjuvant chemo therapy for head and neck cancer.
Scientific Title Evaluation of effects of oral nutrition enriched with Eicosapentaenoic acid(EPA) in patients underwent neoadjuvant chemo therapy for head and neck cancer.
Scientific Title:Acronym Evaluation of effects of oral nutrition enriched with Eicosapentaenoic acid(EPA) in patients underwent neoadjuvant chemo therapy for head and neck cancer.
Region
Japan

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

Objectives
Narrative objectives1 To examine the effect of oral nutrition enriched EPA in patients who receiving neoadjuvant chemotherapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes transition of nutritional condition and inflammatory reaction.
Key secondary outcomes length of hostpitalization
adverse event
rate of completion for radical therapy
survival rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation
Institution consideration
Blocking NO
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 EPA-enriched oral nutrition of 2 packs and oral nutrition with EHA of 250ml was taken 6 to 7 weeks duraing neoadjuvant chemotherapy.
Interventions/Control_2 oral nutrition with EHA of 250ml was taken 6 to 7 weeks duraing neoadjuvant chemotherapy.
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 daiagnosed SCC
2.patients had untreatement head and neck squamous cell carcinoma who needs neoadjuvant chemotherapy
3. ECOG PS of 0, 1 or 2 and the patients who can attend a hospital as a outpatient
4.Written informed consent
5.Sufficient oral or enteral intake
6.Confirmed by the following data
white blood cell count 3000-9000/mm3.
platelet count over 100,000/mm3.
hemoglobin count over 9.0g/dl.
serum creatinine below 1.2mg/dl.
creatinine clearance over 60 ml/min


Key exclusion criteria 1.with incurable other cancer
2.with obvious infectious disease
3.Uncontrollable diabetes mellitus
4.oral administration of steroid
5.with cardiac, liver, or renal failure
6.with allergy of milk and soybean
7.pregnant, lactating women or women of childbearing potential
8.with chronic inflammatory disease
9.lack of agreement
10.incidence of cerebral hemorrhage or subarachnoid hemorrhage within 1 month before registration
11.oral administration of EPA before registration
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jyunkichi Yokoyama
Organization Juntendo University school of medicine
Division name Department of Otolaryngology, head and neck surgery
Zip code
Address 2-1-1, Hongo, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Juntendo University school of medicine
Division name Department of Otolaryngology, head and neck surgery
Zip code
Address
TEL 03-3813-3111
Homepage URL
Email

Sponsor
Institute Juntendo University school 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
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

Other administrative information
Date of disclosure of the study information
2012 Year 05 Month 01 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 Open public recruiting
Date of protocol fixation
2012 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 05 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 04 Month 26 Day
Last modified on
2013 Year 04 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009244

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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