UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014857
Receipt number 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 18:30:40

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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 or person

Institute

Tottori University Hospital

Institute

Department

Personal name



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

Value
https://center6.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