UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018205 |
|---|---|
| Receipt number | 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 15:10:59 |
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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
| Obstetrics 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
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
isohashi@radonc.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021079
