NCT06102447尚未招募不适用
Efficacy and Safety of Netupitant and Palonosetron Hydrochloride Capsules in Preventing Nausea and Vomiting Induced by Radiochemotherapy in Head and Neck Squamous Cell Carcinoma
Sichuan Cancer Hospital and Research Institute1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2023年11月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The complete response rate during synchronous radiotherapy and chemotherapy (defined as no vomiting episodes and no emergency medication).
研究概览
简要总结
The enrolled head and neck squamous cell carcinoma patients in this study received high-dose multiday chemotherapy with cisplatin and synchronous radiation therapy, which had a high risk of nausea and vomiting. On the first and third days, they took Netopitam Palonosetron capsules and dexamethasone to reduce the incidence of acute vomiting. The aim of this study is to evaluate the antiemetic effect of Netopitam Palonosetron capsules and to explore the effectiveness of using Netopitam Palonosetron capsules again for antiemetic treatment during the study period when breakthrough vomiting occurs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18-75 years old;
- •Head and neck tumors confirmed by histology or cytology (including oral cancer, oropharyngeal cancer, hypopharyngeal cancer, and laryngeal cancer);
- •Receive radical synchronous radiotherapy and chemotherapy;
- •The Eastern Oncology Collaborative Group (ECOG) physical fitness score of the subjects was ≤ 2 points;
- •Adequate organ and bone marrow function;
- •The expected life is at least 12 weeks;
- •Pregnant or fertile patients (male or female) use reliable contraceptive measures;
- •When screening female patients with potential pregnancy, the pregnancy test must be negative;
- •The subjects voluntarily and strictly comply with the requirements of the research protocol and sign a written informed consent form.
排除标准
- •Recurrent and metastatic head and neck tumors;
- •Previously underwent tumor resection surgery for treatment;
- •Patients with platinum drug intolerance;
- •Receiving any known or potential antiemetic medication within 24 hours prior to the first day, or experiencing symptoms of vomiting, retching, or mild nausea within 24 hours prior to the first day;
- •Take NK1（neurokinin-1） receptor antagonists or any study medication within 4 weeks before the start of the experiment;
- •Use CYP3A4 inducer within 4 weeks before chemotherapy, and use CYP3A4 substrate or strong or moderate CYP3A4 inhibitor within 1 week;
- •Serious cardiovascular, pulmonary, diabetes, mental and other diseases;
- •Pregnant or lactating women, patients with fertility who are unwilling or unable to take effective contraceptive measures;
- •Drug and/or alcohol abuse;
- •Hypocalcemia or any other condition that may cause vomiting;
- •There are significant factors that affect the absorption of oral medication, such as chronic diarrhea and intestinal obstruction;
- •The subject has allergic reactions to Netopitam Palonosetron capsules or any of their excipients;
- •Within 30 days prior to the baseline visit, the subject participated in another clinical study and used any exploratory drugs or devices; Allow participation in observational research;
- •The researcher determines other situations that may affect the progress of clinical research and the determination of research results.
研究组 & 干预措施
Treatment Group
Experimental
干预措施: Netopitam Palonosetron capsules and dexamethasone (Drug)
结局指标
主要结局
The complete response rate during synchronous radiotherapy and chemotherapy (defined as no vomiting episodes and no emergency medication).
时间窗: 1 month
次要结局
- No significant nausea rate during synchronous radiotherapy and chemotherapy(1 month)
- Nausea free rate during synchronous radiotherapy and chemotherapy(1 month)
- No vomiting rate during synchronous radiotherapy and chemotherapy(1 month)
- The rate of non emergency medication during synchronous radiotherapy and chemotherapy(1 month)
- The prevalence and severity of oral/oropharyngeal mucositis during synchronous radiotherapy and chemotherapy(1 month)
- Successful rescue rate of breakthrough vomiting: (defined as no vomiting within 48 hours)(1 month)
- Evaluate the impact of medication on patients' daily activities of life (evaluated based on the nausea and vomiting questionnaire FLIE)(1 month)
研究者
Yangkun Luo
Study Director
Sichuan Cancer Hospital and Research Institute
研究点 (1)
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