UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of elemental diet (Elental) on diarrhea in patients with gynecologic malignancies treated with pelvic radiotherapy
Title of the study (Brief title)	Efficacy of elemental diet (Elental) on diarrhea in patients treated with pelvic radiotherapy
Region	Japan

Condition
Condition	patients with gynecologic malignancies treated with pelvic radiotherapy
Classification by specialty	Obsterics and gynecology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study was to evaluate the efficacy of elemental die(Elental) on patients with gynecologic malignancies treated with pelvic radiotherapy.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	diarrhea (duration or grade) during radiotherapy
Key secondary outcomes

Base
Study type

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	Medicine
Interventions/Control_1	The group administered on Erental
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	Female
Key inclusion criteria	(1) The patients who receive pelvic radiotherapy against gynecologic malignancies. (2)The patients who is more than twenty years old. (3) The patients who obtain informed consent.
Key exclusion criteria	(1) The patients who has a history of gastrointestinal surgery. (2) The patients who has severe disorders of liver and kidney. (3)The patients who has uncontrolled diabetes. (4) the patients who has a history of another elemental diet. (5)The patients who has a history of Erental intake with 1 month. (6) The patients who is not suitable for this study by doctors.
Target sample size	24

Research contact person
Name of lead principal investigator	Fumiaki ISOHASHI
Organization	Osaka University Graduate School of Medicine
Division name	Department of Radiation Oncology
Address	2-2 (D10) Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3482
Email	isohashi@radonc.med.osaka-u.ac.jp

Public contact
Name of contact person	Fumiaki ISOHASHI
Organization	Osaka University Graduate School of Medicine
Division name	Department of Radiation Oncology
Address	2-2 (D10) Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3482
Homepage URL
Email	isohashi@radonc.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Ajinomoto Pharmaceuticals Co.,Inc
Organization
Division
Category of Funding Organization	Profit organization
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

Other administrative information
Date of disclosure of the study information	2015 Year 07 Month 10 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 12 Month 19 Day
Anticipated trial start date	2014 Year 12 Month 19 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	2015 Year 07 Month 06 Day
Last modified on	2018 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021079