UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012740 |
|---|---|
| Receipt number | R000014886 |
| Scientific Title | Pilot study about nutritional effect of elemental diet supplementation during chemoradiotherapy for head and neck cancer. |
| Date of disclosure of the study information | 2014/01/01 |
| Last modified on | 2016/05/17 11:00:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Pilot study about nutritional effect of elemental diet supplementation during chemoradiotherapy for head and neck cancer.
Acronym
Pilot study of nutritional effect of elemental diet by the difference in regimen of chemoradiotherapy for head and neck cancer.
Scientific Title
Pilot study about nutritional effect of elemental diet supplementation during chemoradiotherapy for head and neck cancer.
Scientific Title:Acronym
Pilot study of nutritional effect of elemental diet by the difference in regimen of chemoradiotherapy 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 investigate the nutritional effect of elemental diet in the patient during chemoradiotherapy for head and neck cancer. At the same time, to investigate whether the nutritional effect of the elemental diet changes by the difference in regimen of the chemotherapeutic agent.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Change of nutritional status during chemoradiotherapy, serum albumin, rapid turnover protein and CRP
Key secondary outcomes
1)Physical examination, blood biochemistries
2)Adverse events
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Elemental diet (300kcal/day) administration for at least 2 weeks from start of chemotherapy containing 5-FU
Interventions/Control_2
Elemental diet (300kcal/day) administration for at least 2 weeks from start of chemotherapy without 5-FU
Interventions/Control_3
No administration of elemental diet
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with head and neck cancer who will undergo chemotherapy.
2.Patient age at the time of obtaining informed consent is 20 years of age or older.
3.Written informed consent.
Key exclusion criteria
1.Past history of serious drug hypersensitivity.
2.Severe diabetes or possibility of glucose metabolism abnormality due to high-dose steroid treatment.
3.Abnormality in amino acid metabolism.
4.Pregnant or nursing women and those with the possibility of pregnancy.
5.Participation judged by physician to be inadvisable.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kiyoaki Tsukahara |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Otorhinoryngology, Head and Neck surgery
Zip code
Address
1163 Taktemachi Hachioji-shi Tokyo
TEL
042-665-5611
tsuka@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kiyoaki Tsukahara |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Otorhinoryngology, Head and Neck surgery
Zip code
Address
1163 Taktemachi Hachioji-shi Tokyo
TEL
042-665-5611
Homepage URL
tsuka@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University Hachioji Medical Center
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
東京医科大学八王子医療センター（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | 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
Completed
Date of protocol fixation
| 2011 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 09 | 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
| 2013 | Year | 12 | Month | 31 | Day |
Last modified on
| 2016 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014886
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
