A study on the prevention of exacerbation of oral mucositis by early initiation of Episil oral liquid in hematopoietic stem cell transplant recipients and head and neck cancer patients

A study on the prevention of exacerbation of oral mucositis by early initiation of Episil oral liquid in hematopoietic stem cell transplant recipients and head and neck cancer patients - A study on prevention of oral mucositis exacerbation by early initiation of Episil oral liquid

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000045409

Enrollment

Registered

2021-09-07

Start date

2021-08-31

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

Head and neck cancer, Hematological malignancy

Interventions

Use Episil after the detection of Grade 1 oral mucositis (CTCAE v.5) Use Episil after the detection of Grade2 or higher oral mucositis (CTCAE v.5)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Hematopoietic stem cell transplant patients 2) Head and neck chemo-radiotherapy patients

Exclusion criteria

Exclusion criteria: 1) Patients who need assistance in using Episil. 2) Patients with lesions including the central nervous system (CNS), or having confirmed/suspected of metastasis/invasion in the CNS 3) Patients using opioids for pain management prior to the start of Episil administration. 4) Patients with serious infections or complication. 5) Patients with known allergy to any of the ingredients in Episil. 6) Patients judged to be inappropriate by the investigator.

Design outcomes

Primary

Measure	Time frame
Oral mucositis pain (every week from the start of treatment, up to 4 weeks from the end of treatment)	—

Secondary

Measure	Time frame
Severity of oral mucositis, Nutritional assessment, Eating Status Scale, Pain control, usability	—

Countries

Japan

Contacts

Public ContactMutsumi Yamakoshi

Fujita Health University Hospital Department of Dentistry and Oral-maxillofacial Surgery

yama-dh@fujita-hu.ac.jp0562-93-2210

Outcome results

None listed

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