Phase 2
N=94
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
Head and Neck Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02085460 ↗Enrolled (actual)
94
Serious AEs
14.9%
Results posted
Apr 2021
Primary outcome: Primary: Incidence of Grade ≥3 Oral Mucositis Determined by Clinical Examination and Assessed by Central Review According to the Common Terminology Criteria of Adverse Events (CTCAE) Version 3.0. — 29.0; 25.0; 38.7 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); 2% Rebamipide liquid (Drug); 4% Rebamipide liquid (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Primary completion
- Aug 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Grade ≥3 Oral Mucositis Determined by Clinical Examination and Assessed by Central Review According to the Common Terminology Criteria of Adverse Events (CTCAE) Version 3.0. |
29.0; 25.0; 38.7 | — |
| SECONDARY Number of Subjects Who Did Not Developed Grade ≥3 Mucositis |
31; 31; 31; 29; 31; 30 | — |
Summary
To investigate the efficacy and safety of rebamipide liquid for chemoradiotherapy-induced oral mucositis in patients with head and neck cancer following administration of rebamipide and to determine the optimal dose of rebamipide.
Eligibility Criteria
Inclusion Criteria
- Head and neck cancer patients scheduled for definitive or postoperative chemoradiotherapy.
- Patients with a histopathological diagnosis of head and neck cancer and primary tumor in one of the following regions.
- Definitive therapy: nasopharynx, oropharynx, hypopharynx, or larynx
- Postoperative therapy: oral cavity, oropharynx, hypopharynx, or larynx
- Patients with no history of chemotherapy, radiotherapy, or chemoradiotherapy for head and neck cancer
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Patients who are able to hold fluid in the mouth
- Patients who are able to swallow the investigational medicinal product (IMP)
- Patients expected to survive for at least 3 months
- Patients who have given written informed consent in person
- Patients who can stay at or visit the hospital for scheduled examinations and observations
- 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
- Patients with primary malignant tumors other than head and neck cancer.
- Patients with symptomatic viral, bacterial, or fungal infection
- Patients with serious renal impairment
- Patients with distant metastasis
- Patients with severe complications (uncontrolled cardiac disease, diabetes, hypertension, etc)
- Patients with any of the following laboratory test results:
- Neutrophil count: 3 times the upper limit of the reference value at the trial site
- Alanine aminotransferase (ALT): >3 times the upper limit of the reference value at the trial site
- Serum bilirubin: >1.5 times the upper limit of the reference value at the trial site
- Serum albumin: 1.5 the upper limit of the reference value at the trial site
- Creatinine clearance : <30 mL/min
- Patients complicated with autoimmune disease
- Patients requiring continuous systemic administration of glucocorticoid
- Female patients who are pregnant or lactating, who may possibly be pregnant, or who wish to become pregnant
- Patients who have participated in any other clinical trial within 4 weeks prior to initiation of chemoradiotherapy
- Patients who have a history of drug allergy to rebamipide, cisplatin, or other platinum compounds
- Patients who are otherwise judged by the investigator or sub-investigator to be inappropriate for inclusion in the trial
Data sourced from ClinicalTrials.gov (NCT02085460). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.