UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000037077
Receipt number 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 2021/06/21 18:38:02

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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

Oto-rhino-laryngology

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 Emi
Middle name
Last name Saito

Organization

Yokohama City University hospital

Division name

Nursing Department

Zip code

2320024

Address

4-57 Urafunecho, Minamiku, Yokohama

TEL

0452615656

Email

emis1309@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

Nursing Department

Zip code

2320024

Address

4-57 Urafunecho, Minamiku, Yokohama

TEL

0452615656

Homepage URL


Email

h10m2101@yahoo.co.jp


Sponsor or person

Institute

Yokohama City University hospital

Institute

Department

Personal name



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

2018 Year 11 Month 08 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

2021 Year 06 Month 21 Day



Link to view the page

Value
https://center6.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