UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of using Synbiotics during neoadjuvant chemotherapy in pancreatic and biliary cancer patients
Title of the study (Brief title)	Synbiotics during neoadjuvant chemotherapy in pancreatic and biliary cancer
Region	Japan

Condition
Condition	pancreatic cancer, biliary cancer
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of synbiotics in nutritional parameter during neoadjuvant chemoradiotherapy in patients with pancreatic and biliary cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Nutritional parameter
Key secondary outcomes	Incidence of adverse events during chemoradiotherapy, Incidence of postoperative infectious complications, fecal microflora, fecal organic acid

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine Food
Interventions/Control_1	Synbiotics treatment during chamoradiotherapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients with pancreatic and biliary cancer, who are scheduled to receive neoadjuvant chemoradiotherapy -Performance status is 0-2 -No serious abnormality in heart, lung, bone marrow, liver, and renal functions
Key exclusion criteria	patients who reject to be enrolled in this study Patients who are judged inappropriate for the entry into the study by the investigater
Target sample size	25

Research contact person
Name of lead principal investigator	Masahiko Yano
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Surgery
Address	1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL	06-6972-1181
Email	yano-ma@mc.pref.osaka.jp

Public contact
Name of contact person	Kunihito Gotoh
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Surgery
Address	1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, Japan
TEL	06-6972-1181
Homepage URL
Email	gotou-ku@mc.pref.osaka.jp

Sponsor
Institute	Department of surgery, Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Yakult Central Institute for Microbiological Research
Name of secondary funｄer(s)

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 06 Month 12 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2011 Year 07 Month 29 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2012 Year 06 Month 12 Day
Last modified on	2016 Year 06 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009601