UMIN-CTR Clinical Trial

Basic information
Public title	Diet Counseling with ONS for advanced esophageal and gastric cancer: pilot randomized controlled trial with feasibility study.
Acronym	DiCON study
Scientific Title	Diet Counseling with ONS for advanced esophageal and gastric cancer: pilot randomized controlled trial with feasibility study.
Scientific Title:Acronym	DiCON study
Region	Japan

Condition
Condition	advanced esophageal and gastric cancer
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate appropriate amount of oral nutritional supplement(ONS) to keep body weight for patients with advanced esophageal and gastric cancer who needs systemic chemotherapy.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Changes in the ratio of prealbumin before and after administration of ONS
Key secondary outcomes	Compliance of ONS, Changes in the ratio of various nutritional index before and after administration of ONS

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
Blocking	YES
Concealment	Numbered container method

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	only Diet Counseling
Interventions/Control_2	administration ONS once a day for 14 days
Interventions/Control_3	administration ONS twice a day for 14 days
Interventions/Control_4	administration ONS three times a day for 14 days
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)advanced gastric cancer or esophageal cancer 2)patients who plans 1st line chemotherapy or chemoradiotherapy 3)patients who can eat more than 50% 4)An age of over 20 5)PS ECOG performance status score 0-1 6)Major organs are in normal conditions in 14 days of administration neutrophil count => 1,500/mm3 Hemoglobin => 8.0g/dL Platelet count => 100,000/mm3 Serum bilirubin <= 1.5 mg/dL AST<=100 IU/L ALP<=100 IU/L Serum creatinine <= 2.0 mg/dL Written informed consent must be taken by patients
Key exclusion criteria	1)ileus or subileus symptom 2)Active infectious diseases(except local infection) 3)massive ascites 4)weight loss more than 10% 5)plans triplet chemotherapy for 1st line chemotherapy 6)allergy for ONS 7)Uncontrollable DM 8)Pregnant or lactation women, or women with the possibility of the pregnancy 9)need systemic steroid therapy 10)Severe mental disorders, neurological disease 11)Dementia 12)Patients who are judged inappropriate for the entry into this study by the investigator
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Ichimura
Organization	Cancer Institute Hospital
Division name	Gastroenterological Chemotherapy Department
Zip code	1358550
Address	3-8-31 Ariake, Koto-ku, Tokyo, 135-8550
TEL	03-3520-0111
Email	takashi.ichimura@jfcr.or.jp

Public contact
Name of contact person	1st name Yukiko Middle name Last name Izawa
Organization	Cancer Institute Hospital
Division name	Department of Nutrition
Zip code	1358550
Address	3-8-31 Ariake, Koto-ku, Tokyo, 135-8550
TEL	03-3520-0111
Homepage URL
Email	yukiko.izawa@jfcr.or.jp

Sponsor
Institute	Cancer Institute Hospital Gastroenterological Chemotherapy Department
Institute
Department

Funding Source
Organization	Cancer Institute Hospital Gastroenterological Chemotherapy Department
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Cancer Institute Hospital
Address	3-8-31 Ariake, Koto-ku, Tokyo, 135-8550
Tel	03-3570-0210
Email	med.shinsa@jfcr.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

Other administrative information
Date of disclosure of the study information	2017 Year 05 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
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 03 Month 09 Day
Date of IRB	2017 Year 06 Month 01 Day
Anticipated trial start date	2017 Year 07 Month 25 Day
Last follow-up date	2019 Year 10 Month 01 Day
Date of closure to data entry	2019 Year 10 Month 01 Day
Date trial data considered complete	2019 Year 10 Month 31 Day
Date analysis concluded	2019 Year 12 Month 30 Day

Other
Other related information

Management information
Registered date	2017 Year 03 Month 26 Day
Last modified on	2019 Year 10 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030404