UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016918 |
|---|---|
| Receipt number | R000019637 |
| Scientific Title | Feasibility study about supportive therapy with elemental diet, "elental", for chemotherapy induced oral mucositis in patients with gastorointestinal cancer. |
| Date of disclosure of the study information | 2015/03/26 |
| Last modified on | 2016/10/28 13:47:52 |
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Basic information
Public title
Feasibility study about supportive therapy with elemental diet, "elental", for chemotherapy induced oral mucositis in patients with gastorointestinal cancer.
Acronym
KSCOG CR-05
Scientific Title
Feasibility study about supportive therapy with elemental diet, "elental", for chemotherapy induced oral mucositis in patients with gastorointestinal cancer.
Scientific Title:Acronym
KSCOG CR-05
Region
| Japan |
Condition
Condition
cancer chemotherapy induced oral mucositis
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Study about availability of nutritional therapy with elemental diet as supportive treatment against cancer chemotherapy induced oral mucositis or neutropenia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
improvement of oral mucositis
Key secondary outcomes
change of oral intake
serological change
frequency and degree of adverse event
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients received the same chemotherapy regimen as during the previous treatment in addition received more than 80 g of elemental diet "Elental"
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with colorectal cancer experiencing stomatitis(grade 1-3 on CTC-AE ver3.0) after a course of FOLFOX or FOLFIRI based chemotherapy
1)age over 20 years and under 80 years
2)Performance status(ECOG) 0 - 2
3)life expetancy > 3months
4)without serious disorder in hematopoietic,hepatic and renal function
5)written informed consent
Key exclusion criteria
1)cannot recovered from side effect of adjuvant chemotherapy
2)active infection
3)uncontrollable hypertention
4)uncontrollable diabete
5)clinically considerable cardiac disease
6)serious pulmonaly dissease
7)experience of clinically considerable psychological dysfunction or central nerve dysfunction
8)serious diarrhea
9)continuous systemic steroid treatment
10)pregnant women, nursing mother or women with childbearing intentions
11)participate in other clinical study
12)difficult to oral intake
13)physician judged inadequate for this study
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yutaka Ogata |
Organization
Kurume University
Division name
Department of surgery
Zip code
Address
155-1 Kokubu-machi, Kurume-shi 839-0863, Fukuoka JAPAN
TEL
0942-22-6111
yogata@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yutaka Ogata |
Organization
Kurume University Medical Center
Division name
Department of surgery
Zip code
Address
155-1 Kokubu-machi, Kurume-shi 839-0863, Fukuoka JAPAN
TEL
0942-22-6111
Homepage URL
yogata@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Ajinomoto Pharmaceuticals Co.,Inc.
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
久留米大学、久留米大学医療センター、くるめ病院、社会保険田川病院、公立八女総合病院、大牟田市立病院、済生会大牟田病院、久留米総合病院、朝倉医師会病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 26 | 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
| 2010 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 26 | Day |
Last modified on
| 2016 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019637
