UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Retrospective and prospective study of Efficacy of nutrition intervention (HINEX) combined neoadjuvant chemotherapy for Esophageal Cancer
Title of the study (Brief title)	Efficacy of nutrition intervention (HINEX) combined neoadjuvant chemotherapy for Esophageal Cancer
Region	Japan

Condition
Condition	Esophageal cancer
Classification by specialty	Gastrointestinal surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To invstigate the efficacy of nutrition intervention (HINEX) combined neoadjuvant chemotherapy for Esophageal Cancer
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Incidence of preoperative sarcopenia
Key secondary outcomes	Nutritional assessment, Adverse events of chemotherapy, Antitumor effects, Inflammatory findings, Incidence of infectious complications

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Nutritional Intervention (oralintake of HINEX)
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	*Patients who undergo preoperative chemotherapy for resectable esophageal cancer *Be able to ingest orally *Age more over 20 years *No gender *Eastern Cooperative Oncology Group performance status (ECOG PS) of 1 or less *Adequate baseline organ function *written informed consent to participate in the study
Key exclusion criteria	*contraindications to HINEX *Major complications or active concurrent malignancies *Mental illness *Diabetes treated with insulin *History of drug allergy or difficulty ingesting 5-FU or Cicplatin *Pregnancy or lactation, or intending to conceive *Being assessed by the physician in charge as not appropriate to enter the study.
Target sample size	80

Research contact person
Name of lead principal investigator	Hiroaki Nagano
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Gastroenterological, Breast and Endocrine Surgery
Address	1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan.
TEL	0836-22-2264
Email	hnagano@yamaguchi-u.ac.jp

Public contact
Name of contact person	Shinsuke kanekiyo
Organization	Yamaguchi University Graduate School of Medicine
Division name	Department of Gastroenterological, Breast and Endocrine Surgery
Address	1-1-1 Minami-Kogushi, Ube, Yamaguchi 755-8505, Japan.
TEL	0836-22-2264
Homepage URL
Email	sin018@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi University Hospital
Institute
Department

Funding Source
Organization	Yamaguchi University
Organization
Division
Category of Funding Organization	Other
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	山口大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2018 Year 09 Month 18 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 08 Month 02 Day
Anticipated trial start date	2018 Year 10 Month 01 Day
Last follow-up date
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	2018 Year 09 Month 18 Day
Last modified on	2018 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038967