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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000014857
Receipt No. R000017267
Scientific Title Preventive effects of TJ-14 on oral mucositis with chemotherapy and radiotherapy in head and neck cancer
Date of disclosure of the study information 2014/09/01
Last modified on 2014/08/13

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Basic information
Public title Preventive effects of TJ-14 on oral mucositis with chemotherapy and radiotherapy in head and neck cancer
Acronym Clinical study of TJ-14 for oral mucositis with chemotherapy and radiotherapy in head and neck cancer
Scientific Title Preventive effects of TJ-14 on oral mucositis with chemotherapy and radiotherapy in head and neck cancer
Scientific Title:Acronym Clinical study of TJ-14 for oral mucositis with chemotherapy and radiotherapy in head and neck cancer
Region
Japan

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

Objectives
Narrative objectives1 To evaluate preventive effects of TJ-14 for oral mucositis related to chemotherapy and radiotherapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The inflammatory marker (IL-1, TNF-alpha, PGE2), oxidant stress marker (8-OHdG, AGEs, 8-isoprostane), antioxidant biomarker [SOD, TAC(total antioxidant capacity)]
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of TJ-14 7.5g/day between meals.
Interventions/Control_2 Oral administration of placebo 7.5g/day between meals.
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 Patients with radiation or chemotherapy for head and neck cancer

Patients that oral care is possible

Performance status of 0 or 1
Patients that communication is possible
Patients have adequate function of vital organ
Patients provide written informed consent before initiation of study
Key exclusion criteria Patients that had used Kampo medicine within 1 month before registration
Patients that have an allergy for TJ-14

Patients that don't hope for participation in this study
Interruption of the treatment over 1 month
Serious psychiatric disorder
Patients that will be inappropriate for entry into this study in the judgment of the investigator.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kenkichiro Taira
Organization Tottori University Hospital
Division name Depertment Otolaryngology:Head and Neck surgery
Zip code
Address Nishimachi 36-1, Yonago, Tottori, Japan
TEL 0859-38-6627
Email kenkichiro.t@med.tottori-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenkichiro Taira
Organization Tottori University Hospital
Division name Depertment Otolaryngology:Head and Neck surgery
Zip code
Address Nishimachi 36-1, Yonago, Tottori, Japan
TEL 0859-38-6627
Homepage URL
Email kenkichiro.t@med.tottori-u.ac.jp

Sponsor
Institute Tottori University Hospital
Institute
Department

Funding Source
Organization Tottori University Hospital
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
2014 Year 09 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 Preinitiation
Date of protocol fixation
2014 Year 07 Month 10 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 08 Month 13 Day
Last modified on
2014 Year 08 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017267

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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