UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016542
Receipt number R000016491
Scientific Title Effects of pancrelipase capules on nutrtional condition of chemotherapy patients with unresectable pancreatic cancer:A Randomized Controlled Trial
Date of disclosure of the study information 2015/02/14
Last modified on 2023/02/21 06:03:54

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Basic information

Public title

Effects of pancrelipase capules on nutrtional condition of chemotherapy patients with unresectable pancreatic cancer:A Randomized Controlled Trial

Acronym

Pancrelipase study:RCT

Scientific Title

Effects of pancrelipase capules on nutrtional condition of chemotherapy patients with unresectable pancreatic cancer:A Randomized Controlled Trial

Scientific Title:Acronym

Pancrelipase study:RCT

Region

Japan


Condition

Condition

unresectable pancreatic cancer

Classification by specialty

Medicine in general Hepato-biliary-pancreatic medicine Adult

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effects of pancrelipase capsules on nutritional condition of patients with unresectable pancreatic cancer,by a randomized contraolled trial.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

The nutritional condition of patients with unresectable pancreatic cancer,8weeks after started chemotherapy.

Key secondary outcomes

prognosis,adverse event


Base

Study type


Study design

Basic design

Single arm

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

No treatment

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking


Concealment

Central registration


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

medication/non medication

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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients with unresectable pancreatic cancer who received chemotherapy at first time.

Key exclusion criteria

patient receiving pancreatectomy,pateint with poor oral intake

Target sample size

88


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kenji Hirano

Organization

Graduate School of Medicine,The University of Tokyo

Division name

Department of Gastroenterology

Zip code


Address

7-3-1 Hongo,Bunkyo-ku,Tokyo

TEL

03-3815-5411

Email

khirano-tky@umin.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomotaka Saito

Organization

Graduate School of Medicine,The University of Tokyo

Division name

Department of Gastroenterology

Zip code


Address

7-3-1 Hongo,Bunkyo-ku,Tokyo

TEL

03-3815-5411

Homepage URL


Email

tomsaito623@gmail.com


Sponsor or person

Institute

Department of Gastroenterology,Graduate School of Medicine,The University of Tokyo

Institute

Department

Personal name



Funding Source

Organization

Department of Gastroenterology,Graduate School of Medicine,The University of Tokyo

Organization

Division

Category of Funding Organization

Self funding

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

東京大学医学部附属病院(東京都)、せんぽ高輪病院(東京都)、日本赤十字社医療センター(東京都)、JR東京総合病院(東京都)、関東中央病院(東京都)、東京警察病院(東京都)、三井記念病院(東京都)、杏雲堂病院(東京都)、東芝病院(東京都)


Other administrative information

Date of disclosure of the study information

2015 Year 02 Month 14 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

Completed

Date of protocol fixation

2014 Year 01 Month 20 Day

Date of IRB

2014 Year 02 Month 10 Day

Anticipated trial start date

2014 Year 05 Month 23 Day

Last follow-up date

2017 Year 01 Month 07 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2015 Year 02 Month 14 Day

Last modified on

2023 Year 02 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016491


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name