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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028659
Receipt No. R000032805
Scientific Title Comparison study of the effectiveness of elemental diet during chemotherapy in patients with advanced pancreatic cancer
Date of disclosure of the study information 2017/08/15
Last modified on 2018/02/13

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Basic information
Public title Comparison study of the effectiveness of elemental diet during chemotherapy in patients with advanced pancreatic cancer
Acronym Comparison study of the effectiveness of elemental diet during chemotherapy in patients with advanced pancreatic cancer
Scientific Title Comparison study of the effectiveness of elemental diet during chemotherapy in patients with advanced pancreatic cancer
Scientific Title:Acronym Comparison study of the effectiveness of elemental diet during chemotherapy in patients with advanced 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 evaluate the effectiveness of elemental diet during chemotherapy in patients with unresectable advanced pancreatic cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes overall survival
Key secondary outcomes Body weight, body composition, Plasma protein, CA 19-9, ECOG PS, QOL, Adverse events and tolerability of chemotherapy, Progression-free survival (PFS), Dietary Intake

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients administered elemental diet (1-2 packs per a day) for 3 month during chemotherapy
Interventions/Control_2 Patients administer chemotherapy without nutritional therapy
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 receiving chemotherapy for unresectable advance pancreatic cancer.
Patients gave a consent to participate in the study.
Key exclusion criteria 1. Age under 20 years
2. Allergy to Elental
3. Sever diabetes
4. Pregnant or breastfeeding women
5. Patients with amino acid disorder
6. Patients whom physician considered unqualifiable
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takuji Iwashita
Organization Gifu University Hospital
Division name First Dept. of Internal Medicine
Zip code
Address 1-1 Yanagido, Gifu 501-1194
TEL 058-230-6308
Email takuji@w7.dion.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinya Uemura
Organization Gifu University Hospital
Division name First Dept. of Internal Medicine
Zip code
Address 1-1 Yanagido, Gifu 501-1194
TEL 058-230-6308
Homepage URL
Email ueshin550621@gmail.com

Sponsor
Institute First Dept. of Internal Medicine, Gifu University Hospital
Institute
Department

Funding Source
Organization First Dept. of Internal Medicine, Gifu University Hospital
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

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 15 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 Open public recruiting
Date of protocol fixation
2017 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 08 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 08 Month 14 Day
Last modified on
2018 Year 02 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032805

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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