UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effects of oral nutritional supplement (ONS) during chemoradiotherapy in patients with pancreatic and/or esophageal cancer
Title of the study (Brief title)	The effects of ONS during chemoradiotherapy in patients with pancreatic and/or esophageal cancer
Region	Japan

Condition
Condition	Patients with pancreatic and/or esophageal cancer, who are scheduled to receive chemoradiotherapy
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of ONS (Oral Nutritional Supplement) during chemoradiotherapy for patients with pancreatic and/or esophageal cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	To evaluate the effects of Oral Nutritional Supplement (before chemoradiotherapy, 3 weeks after the beginning of chemoradiotherapy and 1 week after chemoradiotherapy) using the Prognostic Nutrition Index (PNI)
Key secondary outcomes	Serum albumin level Lymphocyte count Arm circumference(AC) Triceps subcutaneous fat(TSF) Body weight and body composition Amount of food intake QOL(EORTC QLQ-C30)

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	For the interventional group, an amount of 500ml/day of oral nutritional supplement(Ensure)is administered for patients who receive chemoradiotherapy(CRT)This nutrition intervention is performed from the start of chemoradiotherapy to the completion of chemoradiotherapy.
Interventions/Control_2	For the control group, diet therapy alone and oral nutritional supplement(Ensure) is administered after onset of anorexia
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. Patients with pancreatic and/or esophageal cancer, who are scheduled to receive chemoradiotherapy 2.Histologically confirmed pancreatic and/or esophageal cancer 3.Patients of age =>20 4.Life expectancy more than 2 months 5.Performance Status: 0-2 (ECOG) 6.Written informed consent
Key exclusion criteria	1.Patients on TPN [total parenteral nutrition] 2.Patients with milk protein allergy 3.Patients with Dysphagia 4.Patients who are judged inappropriate for the entry into the study by the investigater
Target sample size	50

Research contact person
Name of lead principal investigator	Tatsuya Ioka
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Medical Oncology
Address	3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
TEL	06-6972-1181
Email	ioka-ta@mc.pref.osaka.jp

Public contact
Name of contact person	Tatsuya Ioka
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of Medical Oncology
Address	3-3 Nakamichi 1cho-me, Higashinari-ku Osaka, Japan
TEL	06-6972-1181
Homepage URL
Email	ioka-ta@mc.pref.osaka.jp

Sponsor
Institute	Osaka Medical Center for Cancer and Cardiovascular Diseases Department of Medical Oncology
Institute
Department

Funding Source
Organization	Osaka Prefecture
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2011 Year 10 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2010 Year 05 Month 01 Day
Anticipated trial start date	2010 Year 06 Month 01 Day
Last follow-up date	2017 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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

Management information
Registered date	2011 Year 09 Month 02 Day
Last modified on	2017 Year 05 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000006019