UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000041462
Receipt number R000047313
Scientific Title The differences in effectiveness of hydrogel wound covering/protective material (Episil) for oral mucositis caused by chemotherapy and chemoradiotherapy due to the commencement time. - A prospective observational study -
Date of disclosure of the study information 2020/08/19
Last modified on 2022/02/21 12:01:40

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Basic information

Public title

The impact of the commencement time of hydrogel wound covering/protective material (Episil) for oral mucositis caused by chemotherapy and radiotherapy on cancer patients and cancer treatments. - A prospective observational study -

Acronym

An observational study on Episil for chemotherapy and radiotherapy.

Scientific Title

The differences in effectiveness of hydrogel wound covering/protective material (Episil) for oral mucositis caused by chemotherapy and chemoradiotherapy due to the commencement time. - A prospective observational study -

Scientific Title:Acronym

An observational study on the appropriate time of Episil commencement for oral mucositis caused by chemotherapy and chemoradiotherapy.

Region

Japan


Condition

Condition

Head and neck cancer, Hematological malignancy

Classification by specialty

Hematology and clinical oncology Oto-rhino-laryngology Dental medicine

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the differences in effectiveness of hydrogel wound covering/protective material for oral mucositis due to the commencement time.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Oral pain

Key secondary outcomes

Oral mucositis
Body weight
Administration of opioid
Blood test results


Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Gender

Male and Female

Key inclusion criteria

1)Allogeneic hematopoietic stem cell transplant patients and head and neck chemo-radiotherapy patients.
2)Patients who are considered to be appropriate using hydrogel wound covering/protection material.

Key exclusion criteria

1)Oral cancer patients.
2)Patients with wounds except for oral mucositis caused by chemotherapy or radiotherapy.
3)Patients with pain management using opioids before the commencement of hydrogel wound covering/protection material application.
4)Patients who are determined to be inappropriateb y the attending physician.

Target sample size

45


Research contact person

Name of lead principal investigator

1st name Kouji
Middle name
Last name Katsura

Organization

Niigata University Medical and Dental Hospital

Division name

Department of Oral Radiology

Zip code

951-8520

Address

1-754 Asahimachi-dori, Chuo-ku, Niigata city, Niigata, Japan

TEL

025-223-6161

Email

katsu@dent.niigata-u.ac.jp


Public contact

Name of contact person

1st name Kouji
Middle name
Last name Katsura

Organization

Niigata University Medical and Dental Hospital

Division name

Department of Oral Radiology

Zip code

951-8520

Address

1-754 Asahimachi-dori, Chuo-ku, Niigata city, Niigata, Japan

TEL

025-223-6161

Homepage URL


Email

katsu@dent.niigata-u.ac.jp


Sponsor or person

Institute

NIigata University

Institute

Department

Personal name



Funding Source

Organization

None

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

Niigata University Medical and Dental Hospital

Address

1-754 Asahimachi-dori, Chuo-ku, Niigata city, Niigata, Japan

Tel

025-227-2625

Email

ethics@adm.niigata-u.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

2020 Year 08 Month 19 Day


Related information

URL releasing protocol

None

Publication of results

Unpublished


Result

URL related to results and publications

None

Number of participants that the trial has enrolled

45

Results

When our results compare with that of historical control, the degree of pain was better than both the expected value and the threshold value of our setting. The incidence of grade 3 oral mucositis was 14%, which was lower than the incidence of chemoradiotherapy and IMRT.

Results date posted

2022 Year 02 Month 19 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Head and neck chemoradiotherapy patients

Participant flow

considaration of main docter

Adverse events

NOne

Outcome measures

Pain, mucositis

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 09 Month 01 Day

Date of IRB

2019 Year 10 Month 01 Day

Anticipated trial start date

2019 Year 12 Month 01 Day

Last follow-up date

2020 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Approval ID: 2019-0001


Management information

Registered date

2020 Year 08 Month 19 Day

Last modified on

2022 Year 02 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047313


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name