Efficacy and Safety of Lappaconitine Adhesive Patch for the Treatment of Oral Mucositis Pain Caused by Chemoradiotherapy in Patients With Nasopharyngeal Cancer ： A Randomized, Prospective Single-center Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Change from Baseline Numeric Rating Scale for Pain(NRS scale) at 7 weeks
研究概览
简要总结
The purpose of this clinical study is to evaluate the efficacy of lappaconitine adhesive patch in alleviation radiation induced mucositis pain and the improvements in QOL of patients with nasopharyngeal carcinoma . To determine if lappaconitine administered prior to radiation therapy reduces the severity of radiation induced oral mucositis pain in patients who have been diagnosed with nasopharyngeal carcinoma.
详细描述
This is a randomized, single -center study conducted in China to evaluate Lappaconitine Adhesive Patch in the reduction severity of radiation induced oral mucositis pain in patients receiving solo radiation therapy or chemoradiation therapy for nasopharyngeal carcinoma.
Patients will reveive daily fractions of IMRT (2.0 - 2.2 Gy) to a total of 60 - 72 Gy over approximately 7 weeks, plus cisplatin administered 80 - 100 mg/m2 once every three weeks for 3 doses or 30 - 40 mg/m2 once weekly for 6-7 doses (investigator's choice).
Patients in both arms received Intensity Modulated Radiation Therapy(IMRT) :All target volumes were outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes were defined in accordance with the International Commission on Radiation Units and Measurements Reports 50 and 62. The prescribed dose is 68-72 Gy to PTVnx (Planning target volume of the primary tumor), 64-68 Gy to GTVnd (Gross tumor volume of the cervical lymph node), 60- 64Gy to PTVnd and PTV1 (Planning target volume 1), and 54-58 Gy to PTV2 (Planning target volume 2) in 30-32 fractions.
Patients will be randomized equally to 1 of 2 treatment arms:
Arm A: Lappaconitine Adhesive Patch per day, concurrent with stardard care for oral mucositis Arm B: stardard care for oral mucositis
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly histologic diagnosis of nasopharyngeal carcinoma without distant metastasis
- •Clinical stage III~IVa( UICC (Union International Against Cancer) /AJCC (American Joint Committee on Cancer) TNM staging system 8th edition)
- •Karnofsky Performance Status Scale between 60-100
- •WBC count ≥ 4×109/L，neutrophil differential count≥ 1.5×109/L,Hemoglobin ≥ 90g/L， platelet count ≥ 100×109/L
- •ALT or AST ≤2.5×ULN,bilirubin ≤2.5×ULN,Serum creatinine ≤1.5×ULN or Serum creatinine clearance≥60ml/min
- •Sign the informed consent.
排除标准
- •Younger than 18 years old or older than 70 years old
- •Pregnancy or lactation
- •Severe cerebrovascular disease/canker/psychosis/uncontrolled diabetes
- •Have suffered from other tumor or now suffering from other tumor
- •Have suffered from oral diseases or salivary gland diseases or mow suffering from oral diseases or salivary gland diseases
- •Refuse to give up smoking/drinking/betel chewing
- •suffering from other active infection diseases and in need of treatment.
研究组 & 干预措施
Experimental
Lappaconitine Adhesive Patch Lappaconitine Adhesive Patch is administered every radiation day, until the end of radiotherapy.
干预措施: Lappaconitine Adhesive Patch (Drug)
Control
Patients will be given standard care when oral pain is reported
干预措施: standard care (Drug)
结局指标
主要结局
Change from Baseline Numeric Rating Scale for Pain(NRS scale) at 7 weeks
时间窗: The NRS scale will be assessed weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks
The pain caused by oral mucositis for all participants was assessed according to Numeric Rating Scale (NRS scale), by which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. And an 11-point scale where 0 indicates no pain and 10 indicates the worst imaginable pain. The scale for each patient was recorded.
次要结局
- Change from Baseline Karnofsky Performance Status Scale at 7 weeks(The KPS Scale will be recoreded weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks)
- Incidence of Severe Acute Oral Mucositis (Grade of CTCAE ≥ 2)(The WHO score will be assessed weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks.)
- Change from Baseline Quality of Life at 7 weeks(The EORTC QLQ-C30 shoule be completed weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks.)
- The Adverse events Related to lappaconitine(The Adverse events Related to lappaconitinewill be recoreded weekly during concurrent chemoradiotherapy (CCRT) for 7 weeks.)