Head and neck malignancies
Conditions
Interventions
Usage: Rinse with Japanese Pharmacopoeia Honey, spreading it over the left and right cheek mucosa, palate, gums, tongue and floor of the mouth, then swallow slowly. If the patient has difficulty sprea
resume from the next scheduled intake.
For patients requiring sedation, the attending physician will adjust the time at which the medication is administered after thoroughly evaluating the patient's l
Sponsors
Kosugi Kazuhiro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients meeting all of the following criteria are eligible. 1) Patients diagnosed with malignant tumors based on pathology and/or clinical findings 2) Patients aged 1 year or older but under 20 years at the time of informed consent 3) Patients scheduled to receive combined proton beam therapy and chemotherapy 4) Patients whose initial radiation field includes directly visible oral mucosa (tongue, hard palate, buccal mucosa, gingiva, floor of mouth) and/or oropharyngeal mucosa (soft palate, palatine tonsils, posterior wall), and who are expected to receive a total dose of 36 Gy or more 5) Patients who, after receiving sufficient explanation regarding participation in this trial, provided written consent of their own free will, based on full understanding, either personally or through a proxy
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria will be excluded from the study. 1) Patients with an allergy to honey 2) Patients with diabetes 3) Other patients deemed unsuitable as subjects by the principal investigator (or co-investigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence rate of Grade 3 or higher severe oral mucositis according to the Common Terminology Criteria for Adverse Events (CTCAE) ver. 5.0 during the intervention period | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Protocol treatment adherence rate 2) Dropout rate 3) Patient and proxy satisfaction 4) Oral mucositis severity assessment using CTCAE ver.3.0 during the intervention period 5) Duration of Grade 3 or higher oral mucositis per CTCAE ver.5.0 during the intervention period 6) Number of days from proton beam therapy initiation to onset of Grade 3 or higher oral mucositis per CTCAE ver.5.0 7) Intensity of oral mucositis pain 8) Number of days opioids were administered for treatment of oral mucositis during the intervention period 9) Number of days central venous nutrition was administered due to difficulty with oral intake caused by oral mucositis during the intervention period 10) Number of delays in proton beam therapy and chemotherapy caused by the onset of oral mucositis | — |
Contacts
Public ContactKazuhiro Kosugi
University of Tsukuba Hospital
Outcome results
None listed