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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020041
Receipt No. R000023124
Scientific Title Alleviating drymouth by mask-wearing for head and neck cancer patients on chemoradiotherapy
Date of disclosure of the study information 2015/12/11
Last modified on 2015/12/25

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Basic information
Public title Alleviating drymouth by mask-wearing
for head and neck cancer patients
on chemoradiotherapy
Acronym Alleviating drymouth by mask-wearing
for head and neck cancer patients
on chemoradiotherapy
Scientific Title Alleviating drymouth by mask-wearing
for head and neck cancer patients
on chemoradiotherapy
Scientific Title:Acronym Alleviating drymouth by mask-wearing
for head and neck cancer patients
on chemoradiotherapy
Region
Japan

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

Objectives
Narrative objectives1 The efficacy of mask-wearing is to be studied for drymouth patients with head and neck cancer on chemoradiotherapy.The patients will wear masks from one day before chemoradiotherapy starts through two weeks after the completion of the radiotherapy.Two kinds of masks, wet and paper masks are to be compared.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Evaluation by measured moisture/ oral mucosa
from one day before chemoradiotherapy starts
through two weeks after the completion of the radiotherapy.
Key secondary outcomes subjective dryness/ oral cavity
quality/ saliva
severity/ inflamation in oral cavity
pain/ oral cavity
food intake
aspiration pneumonia

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Other
Interventions/Control_1 Group A:wet mask wearing for 9weeks
Interventions/Control_2 Group B:paper mask wearing for 9weeks

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
81 years-old >
Gender Male and Female
Key inclusion criteria 1.The patints on chemotherapy,Cisplatin 20mg/m and Docetaxel10mg/m2,once a week, 6 cycles with the radiotherapy 66Gy or 70Gy
2.PS 0~1
3.able to communication
4.able to wear mask
Key exclusion criteria 1.Patints of the dry mouth or Sjogren's syndrome
2.Patints of respiratory disturbance
3.Patints allergic to mask
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satomi Miki
Organization Osaka University Hospital
Division name East 13th Floor
Zip code
Address 2-15 Yamadaoka,Suita,Osaka,Japan
TEL 06-6879-6500
Email mikistm@hosp.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satomi Miki
Organization Osaka University Hospital
Division name East 13th Floor
Zip code
Address 2-15 Yamadaoka,Suita,Osaka,Japan
TEL 06-6879-6500
Homepage URL
Email mikistm@hosp.med.osaka-u.ac.jp

Sponsor
Institute East 13th Floor,Osaka University Hospital
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
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 大阪大学医学部附属病院(大阪府)

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 11 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 Open public recruiting
Date of protocol fixation
2015 Year 12 Month 11 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 11 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
2015 Year 12 Month 02 Day
Last modified on
2015 Year 12 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023124

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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