臨床研究等提出・公開システム

A Multicenter, Single-Arm, Open-Label Intervention Trial with Historical Control to Explore the Effectiveness of Oral Honey Administration in Preventing Chemoradiotherapy-Induced Oral Mucositis in Pediatric and Adolescent Patients with Head and Neck Malignacies

HARMONIES study (HARMONIES study)

Kosugi Kazuhiro

University of Tsukuba Hospital

2-1-1 Amakubo,Tsukuba,Ibaraki

kosugi.kazuhiro.vd@ms.hosp.tsukuba.ac.jp

Kosugi Kazuhiro

University of Tsukuba Hospital

2-1-1 Amakubo,Tsukuba,Ibaraki

+81-29-853-3691

kosugi.kazuhiro.vd@ms.hosp.tsukuba.ac.jp

Recruiting

Feb. 24, 2026

Interventional

single arm study

open(masking not used)

historical control

single assignment

prevention purpose

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

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)

Both

Head and neck malignancies

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 spreading the medication throughout their mouth, the caregiver should use a syringe to drip small amounts onto the above areas before swallowing.
Dosage: Set the single dose as indicated below and take orally three times daily after each meal.
If the scheduled intake time has passed by more than 2 hours, do not take the dose; 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 level of consciousness.
The administration period is from the start date to the end date of proton beam therapy.

Age Single Dose (ml)
1-3 years 1 ml
4-8 years 2.5 ml
9-12 years 5 ml
13 years and older 10 ml

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

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

+81-29-853-3749

Feb. 18, 2026

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