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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037077
Receipt No. R000040560
Scientific Title Verification of the effect of early moisturizing care on skin disorder of head and neck cancer patients
Date of disclosure of the study information 2019/06/16
Last modified on 2019/06/15

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Basic information
Public title Verification of the effect of early moisturizing care on skin disorder of head and neck cancer patients
Acronym Early moisturizing care for skin disorder of head and neck cancer patients
Scientific Title Verification of the effect of early moisturizing care on skin disorder of head and neck cancer patients
Scientific Title:Acronym Early moisturizing care for skin disorder of head and neck cancer patients
Region
Japan

Condition
Condition Head and neck cancer
Classification by specialty
Oral surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify whether early moisturizing care implementation leads to retardation of skin disorder appearance of head and neck cancer patients undergoing radiochemotherapy and the onset and severity of skin disorders such as keloids
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Number of days required for skin disorder
Key secondary outcomes Skin barrier function (keratin moisture content, percutaneous water transpiration amount, pH)

Base
Study type Interventional

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Intervention group: 1. Moisturizer (Beesoften lotion 0.3%) from skin disorder prevention (radiotherapy start date), 2.Standard treatment after occurrence of skin disorder
Interventions/Control_2 Control group: 1.No preventive intervention before skin disorder occurrence, 2.Standard treatment after occurrence of skin disorder
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 1. Over 20 years old, 2. Patients diagnosed with head and neck cancer and undergoing chemotherapy and radiotherapy,
3. Patients with no history of surgery due to head and neck cancer, 4. Patients with good nutritional status (Alb 3.0, TP 6.0 or above), 5. Patients who can provide independent supplements and can respond to survey items, 6 Patients for whom consent is documented for participation in this study
Key exclusion criteria 1. Patients with diabetes, 2. Allergic skin diseases such as atopy, those with complications of chronic inflammatory skin diseases, those with hemorrhagic hematologic disorder, 4. Patients expected to have serious consequences with minor attendance, 5. Heparin allergy , 6. Other patients judged inappropriate for judgment by doctor's judgment
Target sample size 72

Research contact person
Name of lead principal investigator
1st name Yasuko
Middle name
Last name Shoji
Organization Yokohama City University hospital
Division name Dental surgery
Zip code 2320024
Address 4-57 Urafunecho, Minamiku, Yokohama
TEL 0452615656
Email shoji_y@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Saki
Middle name
Last name Abe
Organization Yokohama City University hospital
Division name Dental surgery
Zip code 2320024
Address 4-57 Urafunecho, Minamiku, Yokohama
TEL 0452615656
Homepage URL
Email shoji_y@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University hospital
Institute
Department

Funding Source
Organization Yokohama City University
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 Yokohama City University
Address 3-9 Hukuura, Kanazawa-ku,Yokohama
Tel 0457872511
Email akase@yokohama-cu.ac.jp

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
2019 Year 06 Month 16 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
2019 Year 03 Month 01 Day
Date of IRB
2019 Year 02 Month 01 Day
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 15 Day
Last modified on
2019 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040560

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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