UMIN-CTR Clinical Trial

Basic information
Public title	Inhibitory effects of dietary glucosylceramides on head and neck squamous cell carcinogenesis and metastasis
Acronym	Carcinogenesis inhibitory effects of glucosylceramide
Scientific Title	Inhibitory effects of dietary glucosylceramides on head and neck squamous cell carcinogenesis and metastasis
Scientific Title:Acronym	Carcinogenesis inhibitory effects of glucosylceramide
Region	Japan

Condition
Condition	head and neck cancer
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate inhibitory effect of dietary glucosylceramide on head and neck carcinogenesis and metastasis
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Disease free survival
Key secondary outcomes	Relapse free survival overall survival

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	Food
Interventions/Control_1	dietary glucosylceramide (3mg/kg/day) 2 years
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	Male and Female
Key inclusion criteria	1 Histological type is squamous cell carcinoma 2 Primary site is paranasal sinus, oral cavity, oropharynx, hypopharynx, larynx. 3 Stage 3 or stage4A, 4B, which had surgery, radiation and chemoradiation. 4 Cases identified as complete response by histological examination and imaging test. 5 20 years of age and older. 6 Ability of oral intake 7 Performance status 0-1 8 No abnormalities of Bone marrow function, renal function, and liver function within the first 14 days. 9 Informed concent is obtained.
Key exclusion criteria	1 Cases with allergic symptom by Konnyaku. 2 Cases with infection disease requiring treatment 3 Cases with gastrointestinal disease requiring treatment 4 Cased with interstitial pneumonia and lung fibrosis. 5 Cases with poorly controlled diabetes. 6 Cases with severe liver damage. 7 Cases with severe diarrhea. 8 Pregnant woman or potential. 9 Cases deemed inappropriate by principal investigator.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazunori Fujiwara
Organization	Tottori University
Division name	Department of Otolaryngology, Head and Neck Surgery
Zip code
Address	36-1, Nishicho, Yonago, Tottori, Japan
TEL	0859-38-6627
Email	kfujiwa@med.tottori-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kazunori Fujiwara
Organization	Tottori University
Division name	Department of Otolaryngology, Head and Neck Surgery
Zip code
Address	36-1, Nishicho, Yonago, Tottori, Japan
TEL	0859-38-6627
Homepage URL
Email	kfujiwa@med.tottori-u.ac.jp

Sponsor
Institute	Tottori University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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	2019 Year 04 Month 01 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	2011 Year 08 Month 11 Day
Date of IRB	2011 Year 08 Month 11 Day
Anticipated trial start date	2011 Year 08 Month 11 Day
Last follow-up date	2019 Year 03 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 12 Month 05 Day
Last modified on	2019 Year 06 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039971