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
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
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
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
