UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014244
Receipt number R000016534
Scientific Title prevention of radiation induced dermatitis for patients with head and neck cancer comparison of application of urea lotion
Date of disclosure of the study information 2014/06/13
Last modified on 2014/12/15 10:06:54

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Basic information

Public title

prevention of radiation induced dermatitis for patients with head and neck cancer
comparison of application of urea lotion

Acronym

prevention of radiation induced dermatitis for patients with head and neck cancer

Scientific Title

prevention of radiation induced dermatitis for patients with head and neck cancer
comparison of application of urea lotion

Scientific Title:Acronym

prevention of radiation induced dermatitis for patients with head and neck cancer

Region

Japan


Condition

Condition

head and neck cancer

Classification by specialty

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

efficacy

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

efficacy

Key secondary outcomes



Base

Study type


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

application half of neck skin

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

90 years-old >

Gender

Male and Female

Key inclusion criteria

patients treated with radiation therapy by head and neck cancer

Key exclusion criteria

disagreement with a patient and physician in charge

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name tomoko kusunose

Organization

kochi university hospital

Division name

nursing departmennt

Zip code


Address

kohasu oko nankoku kochi

TEL

088-866-5811

Email

jm-to_ku@kochi-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name arisa mituuchi

Organization

kochi university

Division name

nursing department

Zip code


Address

kohasu oko nankoku kochi

TEL

088-866-5811

Homepage URL


Email

jm-mitsuuchi@kochi-u.ac.jp


Sponsor or person

Institute

kochi university hospital

Institute

Department

Personal name



Funding Source

Organization

kochi 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 06 Month 13 Day


Related information

URL releasing protocol


Publication of results

Published


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

Completed

Date of protocol fixation

2012 Year 03 Month 27 Day

Date of IRB


Anticipated trial start date

2012 Year 06 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 06 Month 12 Day

Last modified on

2014 Year 12 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016534


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name