UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000007960
Receipt number R000008400
Scientific Title Prophylactic effect of elemental diet (Elental) on stomatitis in chemo(-radio)therapy to patients with advanced or recurrent esophageal cancer
Date of disclosure of the study information 2012/05/15
Last modified on 2015/10/11 13:19:15

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Basic information

Public title

Prophylactic effect of elemental diet (Elental) on stomatitis in chemo(-radio)therapy to patients with advanced or recurrent esophageal cancer

Acronym

Prophylactic effect of Elental on stomatitis in chemo(-radio)therapy for esophageal cancer

Scientific Title

Prophylactic effect of elemental diet (Elental) on stomatitis in chemo(-radio)therapy to patients with advanced or recurrent esophageal cancer

Scientific Title:Acronym

Prophylactic effect of Elental on stomatitis in chemo(-radio)therapy for esophageal cancer

Region

Japan


Condition

Condition

Esophageal cancer

Classification by specialty

Gastroenterology Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Frequency or severity of oral erosion
Nutrition

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The grade of stomatitis by NCI-CTCAE ver. 4.0
Serum total protein, albimin, T-cholesterol, trigriceride, hemoglobin

Key secondary outcomes

QOL by 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

NO

Dynamic allocation

YES

Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Elental

Interventions/Control_2

Sodium gualenate hydrate

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

1.Histologically confirmed esophageal cancer
2.over 20 and under 80 years of age
3. PS 0-2
4. No prior chemo(-radio)therapy within 6 months
5. Adequate oragn functions
6. Written informed consent

Key exclusion criteria

1. Active infection
2. Presence of ileus
3. Treatment with intravenous hyperalimentation
4. Receiving other enteral alimentation
5. Presence of uncorolled diabetes
6. Inappropriate cases

Target sample size

36


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Satoshi Kokura

Organization

Graduate School of Medical Science, Kyoto Prefectural University of Medicine

Division name

Molecular Gastroenterology and Hepatology

Zip code


Address

Kwaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan

TEL

075-251-5519

Email

s-kokura@koto.kpu-m.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Ishikawa

Organization

Graduate School of Medical Science, Kyoto Prefectural University of Medicine

Division name

Molecular Gastroenterology and Hepatology

Zip code


Address

Kwaramachi-Hirokoji, Kamigyo-ku, Kyoto 602-8566, Japan

TEL

075-251-5519

Homepage URL


Email

iskw-t@koto.kpu-m.ac.jp


Sponsor or person

Institute

Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Cancer Immuno Cell

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


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 05 Month 15 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 11 Month 07 Day

Date of IRB


Anticipated trial start date

2012 Year 01 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2012 Year 05 Month 15 Day

Last modified on

2015 Year 10 Month 11 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008400


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name