UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The feasibility of nutritional supportive care with an eicosapentaenoic acid (EPA)-enriched nutrition agent during pre-operative chemoradiotherapy for pancreatic cancer: prospective randomized control study
Title of the study (Brief title)	Nutrition support for PC patients with NACRT
Region	Japan

Condition
Condition	Resectable and borderline resectable pancreatic cancer pateints
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to clarify the fasibility of Eicosapentaenoic acid (EPA) enriched nutrition support during neoadjuvant chemoradiotherapy for pancreatic cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The before-to-after NACRT ratios (post/pre ratios) of skeletal muscle mass and psoas major muscle area (PMA)
Key secondary outcomes	The post/pre ratios of other nutritional parameters and treatment-related toxicities

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Patients assigned to the Nutrition intervention group received 2 bottles (440 ml) per day (560 kcal/day) of EPA-enriched nutritional supplement (Prosure; Abbott Japan, Tokyo, Japan) during the irradiation component of treatment (about 5 weeks).
Interventions/Control_2	Patients assigned to the Normal diet group have usual meal without special nutritional agent
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	Patients are enrolled in the study when they diagnose with untreated, histopathologically-confirmed, resectable pancreatic cancer (clinical stage IIA or IIB, according to TNM classification, 7th edition and scheduled to receive neoadjuvant chemoradiotherapy (NACRT)
Key exclusion criteria	Patients were excluded from the study when they don't met the following eligibility criteria: (1) an Eastern Cooperative Oncology Group performance status of 0-1; (2) adequate hepatic, renal, and bone-marrow reserves (AST and ALT levels below twice the normal levels; total serum bilirubin <3.0 mg/dl; creatinine level <1.3 mg/dl; leukocyte count>2,000/mm3; hemoglobin >10 g/dl; platelet count >100,000/mm3); (3) capable of oral intake, and (4) written informed consent provided before randomization.
Target sample size	60

Research contact person
Name of lead principal investigator	Hidenori Takahashi
Organization	Osaka International Cancer Institute
Division name	Department of Surgery
Address	3-1-69, Otemae, Chuo-ku, Osaka City, Osaka, 541-8567, JAPAN
TEL	06-6945-1181
Email	takahasi-hi@mc.pref.osaka.jp

Public contact
Name of contact person	Hidenori Takahashi
Organization	Osaka International Cancer Institute
Division name	Department of Surgery
Address	3-1-69, Otemae, Chuo-ku, Osaka City, Osaka, JAPAN
TEL	06-6945-1181
Homepage URL
Email	takahasi-hi@mc.pref.osaka.jp

Sponsor
Institute	Osaka International Cancer Institute
Institute
Department

Funding Source
Organization	The Osaka Foundation for The Prevention of Cancer and Life-style related Diseases
Organization
Division
Category of Funding Organization	Non profit foundation
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	大阪国際がんセンター(大阪府)

Other administrative information
Date of disclosure of the study information	2018 Year 08 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 03 Month 06 Day
Anticipated trial start date	2014 Year 06 Month 01 Day
Last follow-up date	2017 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded	2017 Year 09 Month 30 Day

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

Management information
Registered date	2018 Year 08 Month 01 Day
Last modified on	2018 Year 08 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038300