UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000027256
Receipt No. 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

* 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 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
Email 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
Email sakai@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya Nuiversity Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031222

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.