UMIN-CTR Clinical Trial

Basic information
Public title	Effectiveness of oral elemental nutritional supplement for patients with unresectable pancreatic cancer; a prospective cohort study
Acronym	Effectiveness of oral elemental nutritional supplement for patients with unresectable pancreatic cancer; a prospective cohort study (AOE study)
Scientific Title	Effectiveness of oral elemental nutritional supplement for patients with unresectable pancreatic cancer; a prospective cohort study
Scientific Title:Acronym	Effectiveness of oral elemental nutritional supplement for patients with unresectable pancreatic cancer; a prospective cohort study (AOE study)
Region	Japan

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

Objectives
Narrative objectives1	Effectiveness of oral elemental nutritional supplement
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	Serum albumin at 3 months compare with historical control
Key secondary outcomes	compare with historical control below 1.serum total protein at 3 months 2.how long days patients could receive chemotherapy 3.over all survival 4.progression free survival 5.body weight at 3 month 6.how long days patients could drink elemental nutritional supplement

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	1.previously untreated and histopathologically confirmed unresectable pancreatic cancer patients 2.provided written informed consent
Key exclusion criteria	1.severe complication 2.disability of oral intake 3.Inflammatory bowel disease 4.ECOG scale of performance status 3-4
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Ryo Middle name Last name Harada
Organization	Japanese Red Cross Okayama Hospital
Division name	Department of Gastroenterology
Zip code	700-8607
Address	2-1-1 Aoe, Kita-ku, Okayama City, Okayama, Japan
TEL	086-222-8811
Email	oka-rcgh@okayama-med.jrc.or.jp

Public contact
Name of contact person	1st name Ryo Middle name Last name Harada
Organization	Japanese Red Cross Okayama Hospital
Division name	Department of Gastroenterology
Zip code	700-8607
Address	2-1-1 Aoe, Kita-ku, Okayama City, Okayama, Japan
TEL	086-222-8811
Homepage URL
Email	oka-rcgh@okayama-med.jrc.or.jp

Sponsor
Institute	Department of Gastroenterology, Japanese Red Cross Okayama Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Japanese Red Cross Okayama Hospital
Address	2-1-1 Aoe, Kita-ku, Okayama City, Okayama, Japan
Tel	0862228811
Email	oka-rcgh@okayama-med.jrc.or.jp

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	岡山大学病院（岡山県）

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 01 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	50
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	2017 Year 01 Month 13 Day
Date of IRB	2017 Year 01 Month 06 Day
Anticipated trial start date	2017 Year 02 Month 13 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry	2022 Year 04 Month 01 Day
Date trial data considered complete	2022 Year 04 Month 01 Day
Date analysis concluded	2022 Year 04 Month 01 Day

Other
Other related information	Two centers, open-label, prospective cohort study. Between February 1, 2017, and December 31, 2019, consecutive patients with unresectable pancreatic cancer who met inclusion criteria.

Management information
Registered date	2017 Year 02 Month 02 Day
Last modified on	2022 Year 07 Month 09 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029785