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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033589
Receipt No. R000038300
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
Date of disclosure of the study information 2018/08/01
Last modified on 2018/08/01

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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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
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