UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013158 |
|---|---|
| Receipt number | 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 12:57:34 |
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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
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
tsuka@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University Hachioji Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015345
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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