UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Feasibility study about supportive therapy with elemental diet, "elental", for chemotherapy induced oral mucositis in patients with gastorointestinal cancer.
Title of the study (Brief title)	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	Yutaka Ogata
Organization	Kurume University
Division name	Department of surgery
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	Yutaka Ogata
Organization	Kurume University Medical Center
Division name	Department of surgery
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.

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

Progress
Recruitment status	Completed
Date of protocol fixation	2010 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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