UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007844 |
|---|---|
| Receipt number | 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 18:21:36 |
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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
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
Sponsor or person
Institute
Juntendo University school of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009244
