A Phase 2 Trial of Rebamipide Liquid to Determine the Effective Dose for Prevention of Chemoradiotherapy-induced Oral Mucositis in Patients With Head and Neck Cancer
- Conditions
- oral mucositis in patients with head and neck cancer
- Registration Number
- JPRN-jRCT2080222417
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
The efficacy and safety results of the trial suggest that the optimal dose is rebamipide 4% liquid.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 94
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
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method efficacy<br>Incidence of oral mucositis graded as severe or worse
- Secondary Outcome Measures
Name Time Method efficacy<br>Onset time, duration and incidence of oral mucositis<br><br>efficacy<br>The maximum severity grade for oral mucositis<br><br>efficacy<br>Quality of life