A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group 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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 94
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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: <1500 L
- •Platelet count: <75000 L
- •Hemoglobin: <10.0 g/L
- •Aspartate aminotransferase (AST): >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: <3.0 g/dL
- •Serum creatinine: >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
研究组 & 干预措施
Placebo
6 times daily
干预措施: Placebo (Drug)
2% Rebamipide liquid
6 times daily
干预措施: 2% Rebamipide liquid (Drug)
4% Rebamipide liquid
6 times daily
干预措施: 4% Rebamipide liquid (Drug)
结局指标
主要结局
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.
时间窗: 77 days
Investigators who had undergone specific training assessed the severity of oral mucositis twice every week. To evaluate the severity of oral mucositis objectively, the clinical findings of the oral mucosa as well as functional disorders and symptomatic aspects were recorded in the Oral Mucositis Assessment Sheet by each investigator. Photographic documentation of the oral mucosa was also submitted by each investigator, 3 days before or 57 days after initiation of chemoradiotherapy, or at the time of withdrawal. The Oral Mucositis Assessment Sheets and photographic documentation were then reviewed by the Oral Mucositis Evaluation Committee to grade the severity of oral mucositis according to the CTCAE 3.0.z
次要结局
- Number of Subjects Who Did Not Developed Grade ≥3 Mucositis(Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 77)