UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027256 |
|---|---|
| Receipt number | R000031222 |
| Scientific Title | Improvement of nutritional condition of the patients with inoperable pancreatic cancer by Kestose |
| Date of disclosure of the study information | 2017/05/24 |
| Last modified on | 2017/05/06 23:37:45 |
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Basic information
Public title
Improvement of nutritional condition of the patients with inoperable pancreatic cancer by Kestose
Acronym
Treatment with Kestose for inoperable pancreatic cancer
Scientific Title
Improvement of nutritional condition of the patients with inoperable pancreatic cancer by Kestose
Scientific Title:Acronym
Treatment with Kestose for inoperable pancreatic cancer
Region
| Japan |
Condition
Condition
inoperable pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of Kestose to improve nutritional condition in the patients with inoperable pancreatic cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of nutritional condition in the patients with inoperable pancreatic cancer
Key secondary outcomes
1.Changes of Performance status(KPS)
2.Changes of The European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire(EURTC-QLQ-C30)
3.Changes of total energy expenditure(TEE)
4.Changes of short-chain fatty acid(Butyric acid,Acetic acid,Prorionic acid etc.)
5.Changes of Rapid turnover protein
6.Correlation of gut microbiota and therapeutic effect
7.Metabolome,bile acid and protein analysis of metabolite in feces
8.Correlation between expiratory noble gases,gut microbiota and pancreatic cancer
9.Successful execution rate of Chemotherapy
10.Frequency and degree of side effect
11.Prognosis of inoperable pancreatic cancer
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Kestose
Interventions/Control_2
placebo
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed as inoperable pancreatic cancer
Key exclusion criteria
1.Women with pregnancy or possible pregnancy
2.Patients with severe renal failure and heart failure
3.Patient who is considered to be inappropriate for entry into the trial by the investigator
4.Patients with substantial alcohol consumption(20g/day for women or >30g/day for men
5.Patient who is poor in ingestion
6.Patient with other pancreas disease or other cancer
7.Patient who receive other treatments such as chemotherapy,radiotherapy and operation
8.Patients who take nonabsorbable antibiotics
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiki Hirooka |
Organization
Nagoya Nuiversity Hospital
Division name
Department of Endoscopy
Zip code
Address
65,Tsuruma-cho,Showa-ku,Nagoya
TEL
+81-52-744-2602
hirooka@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Sakai |
Organization
Nagoya University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
65,Tsuruma-cho,Showa-ku,Nagoya
TEL
+81-52-744-2602
Homepage URL
sakai@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya Nuiversity Hospital
Institute
Department
Personal name
Funding Source
Organization
B Food Science Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2017 | Year | 05 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2017 | Year | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 15 | 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
| 2017 | Year | 05 | Month | 06 | Day |
Last modified on
| 2017 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031222
