oral mucositis in patients with head and neck cancer
Conditions
Interventions
investigational material(s)
Generic name etc : 2% Rebamipide liquid
INN of investigational material : Rebamipide
Therapeutic category code : 232 Agents for peptic ulcer
Dosage and Administration for I
Sponsors
Otsuka Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Head and neck cancer patients scheduled for definitive or postoperative chemoradiotherapy. 2) Patients with a histopathological diagnosis of head and neck cancer and primary tumor in one of the following regions. a) Definitive therapy: nasopharynx, oropharynx, hypopharynx, or larynx b) Postoperative therapy: oral cavity, oropharynx, hypopharynx, or larynx 3) Patients with no history of chemotherapy, radiotherapy, or chemoradiotherapy for head and neck cancer 4) Patients with an ECOG performance status score of 0 or 1 5) Patients who are able to hold fluid in the mouth 6) Patients who are able to swallow the investigational medicinal product 7) Patients expected to survive for at least 3 months 8) Patients who have given written informed consent in person 9) Patients who can stay at or visit the hospital for scheduled examinations and observations 10) Patients who are able to take contraceptive measures to avoid pregnancy of the patient or their partner from the time of informed consent until 4 weeks after completion of IMP administration
Exclusion criteria
Exclusion criteria: 1) Patients with primary malignant tumors other than head and neck cancer. 2) Patients with symptomatic viral, bacterial, or fungal infection 3) Patients with serious renal impairment 4) Patients with distant metastasis 5) Patients with severe complications (uncontrolled cardiac disease, diabetes, hypertension, etc) 6) Patients with any of the following laboratory test results: a) Neutrophil count: less than 1500/uL b) Platelet count: less than 75000/uL c) Hemoglobin: less than 10.0 g/L d) AST: more than 3 times the upper limit of the reference value at the trial site e) ALT: more than 3 times the upper limit of the reference value at the trial site f) Serum bilirubin: more than 1.5 times the upper limit of the reference value at the trial site g) Serum albumin: less than 3.0 g/dL h) Serum creatinine: more than 1.5 times the upper limit of the reference value at the trial site i) Creatinine clearance : less than 30 mL/min 7) Patients complicated with autoimmune disease 8) Patients requiring continuous systemic administration of glucocorticoid 9) Female patients who are pregnant or lactating, who may possibly be pregnant, or who wish to become pregnant 10) Patients who have participated in any other clinical trial within 4 weeks prior to initiation of chemoradiotherapy 11) Patients who have a history of drug allergy to rebamipide, cisplatin, or other platinum compounds 12) Patients who are otherwise judged by the investigator or subinvestigator to be inappropriate for inclusion in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| efficacy Incidence of oral mucositis graded as severe or worse | — |
Secondary
| Measure | Time frame |
|---|---|
| efficacy Onset time, duration and incidence of oral mucositis efficacy The maximum severity grade for oral mucositis efficacy Quality of life | — |
Countries
Japan
Outcome results
None listed