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

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 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


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

Value
https://center6.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