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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000018205
Receipt No. R000021079
Scientific Title Efficacy of elemental diet (Elental) on diarrhea in patients with gynecologic malignancies treated with pelvic radiotherapy
Date of disclosure of the study information 2015/07/10
Last modified on 2018/03/23

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Basic information
Public title Efficacy of elemental diet (Elental) on diarrhea in patients with gynecologic malignancies treated with pelvic radiotherapy
Acronym Efficacy of elemental diet (Elental) on diarrhea in patients treated with pelvic radiotherapy
Scientific Title Efficacy of elemental diet (Elental) on diarrhea in patients with gynecologic malignancies treated with pelvic radiotherapy
Scientific Title:Acronym 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
1st name
Middle name
Last name Fumiaki ISOHASHI
Organization Osaka University Graduate School of Medicine
Division name Department of Radiation Oncology
Zip code
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
1st name
Middle name
Last name Fumiaki ISOHASHI
Organization Osaka University Graduate School of Medicine
Division name Department of Radiation Oncology
Zip code
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)

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
2015 Year 07 Month 10 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 Terminated
Date of protocol fixation
2014 Year 12 Month 19 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000021079

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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