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
Not Applicable
Recruiting
- Conditions
- Head and neck cancer, Hematological malignancy
- Registration Number
- JPRN-UMIN000045409
- Lead Sponsor
- Fujita Health University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Oral mucositis pain (every week from the start of treatment, up to 4 weeks from the end of treatment)
- Secondary Outcome Measures
Name Time Method Severity of oral mucositis, Nutritional assessment, Eating Status Scale, Pain control, usability