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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016918
Receipt No. 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

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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
Email 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
Email yogata@med.kurume-u.ac.jp

Sponsor
Institute Kurume University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019637

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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