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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039971


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name