UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Randomized controlled study of the efficacy of pancreatic enzyme replacement therapy with pancrelipase for pancreatic exocrine insufficiency in patients with unresectable pancreatic cancer.
Title of the study (Brief title)	Randomized controlled study of the efficacy of pancreatic enzyme replacement therapy with pancrelipase for pancreatic exocrine insufficiency in patients with unresectable pancreatic cancer.
Region	Japan

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

Objectives
Narrative objectives1	To assess the efficacy of pancreatic enzyme replacement therapy with pancrelipase for pancreatic exocrine insufficiency in patients with unresectable pancreatic cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The change in body weight from baseline to 3 months
Key secondary outcomes

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	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Oral administration of pancrelipase (1800mg/day for 3 months)
Interventions/Control_2	Oral administration of pancreatin (3000mg/day for 3 months)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	(1)Patients with cytologically or histologically proven, unresectable adenocarcinoma of the pancreas (2)Age >= 20 years (3)ECOG Performance status of 0-1 (4)Written informed consent (5)Estimated prognosis >= 3 months (6)adequate oral intake (7)adequate organ function
Key exclusion criteria	(1)Gastrointestinal obstruction (2)Severe concurrent disease (3)Pregnant or lactating women (4)Hypersensitivity to porcine or bovine protein, or severe drug hypersensitibity (5)History of gastrointestinal tract surgery (6)Prior chemotherapy or radiotherapy (7)Mental disorder (8)Inadequate physical condition
Target sample size	80

Research contact person
Name of lead principal investigator	Taketo Yamaguchi
Organization	Chiba Cancer Center
Division name	Gastroenterology
Address	666-2 Nitona-cho, Chuo-ku, Chiba, Japan
TEL
Email

Public contact
Name of contact person
Organization	Chiba Cancer Center
Division name	Gastroenterology
Address
TEL	043-264-5431
Homepage URL
Email

Sponsor
Institute	Chiba Cancer Center
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	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2013 Year 01 Month 31 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 03 Month 15 Day
Anticipated trial start date	2013 Year 04 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	2013 Year 01 Month 30 Day
Last modified on	2016 Year 04 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011497