UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038541 |
|---|---|
| Receipt number | R000043312 |
| Scientific Title | Uncontrolled exploratory clinical trial on the safety of steroid ointment for oral mucositis associated with anticancer treatment |
| Date of disclosure of the study information | 2019/11/11 |
| Last modified on | 2022/07/11 17:22:00 |
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Basic information
Public title
Uncontrolled exploratory clinical trial on the safety of steroid ointment for oral mucositis associated with anticancer treatment
Acronym
Clinical trial of steroid ointment for oral mucositis associated with anticancer drug treatment
Scientific Title
Uncontrolled exploratory clinical trial on the safety of steroid ointment for oral mucositis associated with anticancer treatment
Scientific Title:Acronym
Clinical trial of steroid ointment for oral mucositis associated with anticancer drug treatment
Region
| Japan |
Condition
Condition
Hematopoietic malignancy
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the safety of steroid ointment for oral mucositis associated with anticancer drug treatment.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rate of oral candidiasis up to 17 days after the start of study treatment (or 7 days after the completion of study treatment)
Key secondary outcomes
1. Difference in score of PROMS scale between day1 and day10 or study treatment completion date
2. Difference in score of NRS between day1 and day10 or study treatment completion date
3. Difference in Grade of Oral mucositis CTCAE v5.0 between day1 and day10 or study treatment completion date
4. Adverse events and serious adverse events up to 17 days after the start of study treatment or 7 days after completion of study treatment
5. Incidence rate of infection up to 17 days after the start of study treatment or 7 days after the completion of study treatment
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Apply dexartin oral ointment 3 times a day after each meal to the site of oral mucositis for 10 days
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.Patients with hematopoietic malignancies such as acute myeloid leukemia, acute lymphoblastic leukemia, malignant lymphoma who are being treated with an anticancer drug in hospital.
2. Patients with Grade 2 or 3 oral mucositis based on CTCAE v5.0.
3. The age of consent acquisition is 20 years or older.
4. Patients who have given written informed consent to participate in this study.
Key exclusion criteria
1. Patients undergoing hematopoietic stem cell transplantation.
2. Patients who have been previously treated with this study.
3. Patients with herpes gingiv stomatitis or oral candidiasis.
4. Patients with a history of oral candidosis
5. Patients with malignant tumor lesions in the oral cavity.
6. Patients with a history of surgery and radiation therapy for malignant tumor lesions in the oral cavity.
7. Patients with saliva secretion disorder.
8. Patients with contraindications or hypersensitivity to study treatments.
9. Patients who have psychosis or psychiatric symptoms and are considered difficult to participate in the study.
10. In addition, patients who are judged to be inappropriate for safe implementation of this study by the attending physician.
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | Hironobu |
| Middle name | |
| Last name | Minami |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Medical Oncology and Hematology
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture, JAPAN
TEL
078-382-5111
hminami@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Miki |
| Middle name | |
| Last name | Saeki |
Organization
Kobe University Graduate School of Medicine
Division name
Department of Medical Oncology and Hematology
Zip code
650-0017
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture, JAPAN
TEL
078-382-5111
Homepage URL
m.saeki20@gmail.com
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
Department of Medical Oncology and Hematology, Kobe University Graduate School of Medicine
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
Kobe University Hopital
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture, JAPAN
Tel
078-382-5111
kainyu@med.kobe-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
| 2019 | Year | 11 | 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
| 2019 | Year | 11 | Month | 07 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 06 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 01 | 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 | 11 | Month | 11 | Day |
Last modified on
| 2022 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043312
