UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020041 |
|---|---|
| Receipt number | 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 18:39:33 |
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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
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
mikistm@hosp.med.osaka-u.ac.jp
Sponsor or person
Institute
East 13th Floor,Osaka University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023124
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
