UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035146 |
|---|---|
| Receipt number | R000039971 |
| Scientific Title | Inhibitory effects of dietary glucosylceramides on head and neck squamous cell carcinogenesis and metastasis |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2019/06/12 10:40:42 |
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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
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
kfujiwa@med.tottori-u.ac.jp
Sponsor or person
Institute
Tottori University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039971
