UMIN-CTR Clinical Trial

Basic information
Public title	A clinical trial of the effect of the elemental diet (Elental) on adverse events of DCF therapy (Docetaxel plus 5-fluorouracil and cisplatin) in patients with esophageal cancer.
Acronym	A clinical trial of the effect of the elemental diet on adverse events of DCF therapy in patients with esophageal cancer.
Scientific Title	A clinical trial of the effect of the elemental diet (Elental) on adverse events of DCF therapy (Docetaxel plus 5-fluorouracil and cisplatin) in patients with esophageal cancer.
Scientific Title:Acronym	A clinical trial of the effect of the elemental diet on adverse events of DCF therapy in patients with esophageal cancer.
Region	Japan

Condition
Condition	esophageal cancer
Classification by specialty	Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of supportive care by the elemental diet (Elental) against gastrointestinal toxicity from DCF therapy in patients with esophageal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase III

Assessment
Primary outcomes	The incidence of gastrointestinal toxicity (grade 2 or higher) during three courses of DCF therapy
Key secondary outcomes	The following are assesed during three courses of DCF therapy, 1) Incidence of adverse events 2) Nutritional condition s(body weght, muscle mass, blood test, urine analysis, N-balance) 3) Quality of Life 4) Response rate

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Patients of this trial group will take two packs of the elemental diet (Elental) a day as long as possible after initiation of DCF therapy. When taking two packs is difficult, the dosage of the elemental diets (Elental) will be reduced suitable for the patient condition..
Interventions/Control_2	Patients of this control group will take regular diet only.
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	The following patients (1) patients with histological squamous cell carcinoma (2) patients in stage II/III/IV (UICC ver.7) (3) patients receiving DCF therapy (DTX750mg/m2,day1), CDDP(75mg/m2,day1), 5-FU(750mg/m2,day1-5) (4) 20<=age of patient <=80years-old (5) patients having PS=0,1,2 (6) patients being able to take the elemental diet (Elental) (7) patients who agreed with written informed consent
Key exclusion criteria	The following patients (1) patients considered inadequate for inclusion in this trial by the physician (2) patients with the past history of hypersensitivity to Elental
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Wasaburo Koizumi
Organization	Kitasato University School of Medicine
Division name	Gastroenterology
Zip code
Address	1-15-1 Kitasato, Sagamihara, Kanagawa
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Chikatoshi Katada
Organization	Kitasato University School of Medicine
Division name	Gastroenterology
Zip code
Address	1-15-1 Kitasato, Sagamihara, Kanagawa
TEL	042-778-8111
Homepage URL
Email	ckatada@med.kitasato-u.ac.jp

Sponsor
Institute	Department of Gastroenterology Kitasato University School of Medicine
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	None
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2012 Year 03 Month 30 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	2011 Year 12 Month 21 Day
Date of IRB	2011 Year 12 Month 21 Day
Anticipated trial start date	2012 Year 03 Month 01 Day
Last follow-up date	2019 Year 02 Month 01 Day
Date of closure to data entry	2019 Year 02 Month 01 Day
Date trial data considered complete	2019 Year 02 Month 01 Day
Date analysis concluded	2019 Year 02 Month 10 Day

Other
Other related information

Management information
Registered date	2012 Year 03 Month 29 Day
Last modified on	2021 Year 04 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008985