Uncontrolled exploratory clinical trial on the safety of steroid ointment for oral mucositis associated with anticancer treatment

Uncontrolled exploratory clinical trial on the safety of steroid ointment for oral mucositis associated with anticancer treatment - Clinical trial of steroid ointment for oral mucositis associated with anticancer drug treatment

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000038541

Enrollment

Registered

2019-11-11

Start date

2020-01-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematopoietic malignancy

Interventions

Apply dexartin oral ointment 3 times a day after each meal to the site of oral mucositis for 10 days

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Incidence rate of oral candidiasis up to 17 days after the start of study treatment (or 7 days after the completion of study treatment)	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactMiki Saeki

Kobe University Graduate School of Medicine Department of Medical Oncology and Hematology

m.saeki20@gmail.com078-382-5111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026