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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038541
Receipt No. 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 2020/04/07

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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
Email hminami@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name Yoko
Middle name
Last name Kozuki
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
Email yisikawa@med.kobe-u.ac.jp

Sponsor
Institute Kobe University
Institute
Department

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
Email 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
2020 Year 04 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043312

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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