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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013158
Receipt No. R000015345
Scientific Title Comparison trial to examine usefulness and safety of nutritional agents with differing fatty acid compositions in head and neck cancer surgery patients with free flaps reconstruction
Date of disclosure of the study information 2014/02/14
Last modified on 2014/02/14

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Basic information
Public title Comparison trial to examine usefulness and safety of nutritional agents with differing fatty acid compositions in head and neck cancer surgery patients with free flaps reconstruction
Acronym examine usefulness and safety of nutritional agents with differing fatty acid compositions in head and neck cancer surgery
Scientific Title Comparison trial to examine usefulness and safety of nutritional agents with differing fatty acid compositions in head and neck cancer surgery patients with free flaps reconstruction
Scientific Title:Acronym examine usefulness and safety of nutritional agents with differing fatty acid compositions in head and neck cancer surgery
Region
Japan

Condition
Condition head and neck cancer surgery patients with free flaps reconstruction
Classification by specialty
Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The objective of the present trial is to evaluate the usefulness and safety of Oxepa® with respect to outcome improvement in the case of head and neck cancer patients who have undergone highly invasive surgery with free flaps reconstruction.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in maximum body temperature; CRP; Procalcitonin
Key secondary outcomes Days in ICU; Days in hospital

Base
Study type

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oxepa
Interventions/Control_2 Ensure H
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
90 years-old >=
Gender Male and Female
Key inclusion criteria 1. At least 20 years of age, of either gender
2. Has undergone head/neck cancer surgery with free flaps reconstruction (excepting jejunum surgery cases, no laparotomy)
3. Possibility of nutritional supplementation via enteral nutrition beginning within 24 h of surgery, for at least 5 days
4. Wish to participate in present trial, written informed consent obtained from subject themselves or family member/relative

Patients must fulfill all of criteria 1 to 4 above for participation.
Key exclusion criteria 1. Pregnancy or lactation
2. Less than 20 years of age
3. Very short vital prognosis (expected to live less than 28 days due to uncontrolled cancer or other chronic or incurable terminal diseases)
4. Recent stroke or subarachnoid hemorrhage
5. Non-functioning ileus or intestinal tract
6. Significant immunosuppression (leukocytes<1000 cells/mm3)
7. Infection with human immunodeficiency virus
8. Hyperlipidemia (TG>500, T-cho>300)
9. Unsuitability for enteral nutrition
10.Recent gastrointestinal hemorrhage
11. Poorly controlled diarrhea
12. Congenital metabolism disorder
13. Milk protein intolerance
14. Acute nephritis, nephrosis, end-stage renal disease requiring
strict limitation of protein, electrolytes
15. Cardiac failure accompanied by nausea, vomiting, diarrhea
16. Participation in another trial within 30 days prior to
registration for present trial
17. Judged unsuitable by principal or sub-investigator for other
reasons
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsukahara Kiyoaki
Organization Tokyo Medical University Hachioji Medical Center
Division name Otolaryngology, Head and Neck Surgery
Zip code
Address 1163 Tatemachi, Hachioji, Tokyo, Japan
TEL 0426655611
Email tsuka@tokyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsukahara Kiyoaki
Organization Tokyo Medical University Hachioji Medical Center
Division name Otolaryngology, Head and Neck Surgery
Zip code
Address 1163 Tatemachi, Hachioji, Tokyo, Japan
TEL 0426655611
Homepage URL
Email tsuka@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University Hachioji Medical Center
Institute
Department

Funding Source
Organization Tokyo Medical University Hachioji Medical Center
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
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
2014 Year 02 Month 14 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
2009 Year 08 Month 26 Day
Date of IRB
Anticipated trial start date
2010 Year 01 Month 01 Day
Last follow-up date
2013 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 02 Month 14 Day
Last modified on
2014 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015345

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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