The Open and Multi-center Phase III Clinical Study of Interleukin-11 in the Prevention and Treatment of Radioactive Oral Mucitis
试验速览
- 阶段
- 3 期
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of severe acute radioactive oral mucitis
研究概览
简要总结
Radiation induced oral mucositis which may result in reduced quality of life is commonly seen during radiotherapy, especially combined with chemotherapy. This study is a prospective, multicenter, and exploratory study. The aim of this study is to explore predictive factors of acute radiotherapy induced oral mucositis in nasopharyngeal carcinoma patients treated with radio-chemotherapy and reduce incidence of oral mucositis by using recombinant human interleukin -11.
详细描述
All nasopharyngeal patients received radical treatment including neo-adjuvant chemotherapy and concurrent chemo-radiotherapy. Oral pharyngeal swabs and stool specimen were collected 3times:before neo-adjuvant chemotherapy,before concurrent chemo-radiotherapy and concurrent chemo-radiotherapy finishied. Patients were randomly divided into two groups randomly. IL-11 was used in experience group and control group, saline.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of nasopharyngeal carcinoma.
- •8th version American Joint Committee on Cancer (AJCC) stage I-IVB.
- •Age must beetween 18-
- •Performance status must be 0 or 1 according to Eastern Cooperative Oncology Group.
- •Adequate bone marrow, renal, and hepatic function.
排除标准
- •chemotherapy with fluorouracil drugs; Allergies to recombinant human interleukin-
- •Treatment with palliative intent.;Previous malignancy.
- •Pregnancy or lactation.
- •A history of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes.
- •Diabetes, oral mucositis and senile dry stomatitis.
- •Any severe coexisting disease.
研究组 & 干预措施
Recombinant human interleukin-11
Mixture of 1.5 mg recombinant human interleukin -11(IL-11) and 10ml 0.9% normal saline(NS) was administered twicely to patients through respiratory tract.
干预措施: Recombinant Human Interleukin-11 (Drug)
Recombinant human interleukin-11
Mixture of 1.5 mg recombinant human interleukin -11(IL-11) and 10ml 0.9% normal saline(NS) was administered twicely to patients through respiratory tract.
干预措施: Saline (Drug)
Saline
Only 10ml 0.9% NS was administered twicely to patients through respiratory tract.
干预措施: Saline (Drug)
结局指标
主要结局
Incidence of severe acute radioactive oral mucitis
时间窗: through study completion, an average of 5mouth
Radiation Therapy Oncology Group/European Organization for research and treatment acute radiation morbidity scoring criteria. Grade 0: No change over baseline, Grade 1: Injection/ may experience mild pain not requiring analgesic, Grade 2: Patchy mucositis which may produce an inflammatory serosanguinitis discharge/ may experience moderate pain requiring analgesia, Grade 3: Confluent fibrinous mucositis/ may include severe pain requiring narcotic, Grade 4: Ulceration, hemorrhage or necrosis, Grade 5: death (Higher score equals to worse outcome).
次要结局
- Changes in intestinal flora(through study completion, an average of 5month)
- last period of severe acute radioactive oral mucitis(through study completion, an average of 5month)
- Changes in oral flora(through study completion, an average of 5month)
- Nutritional status(through study completion, an average of 5month)
- Comparison of the occurrence time of severe acute radioactive oral mucitis in two groups(first day from radiation to the date 3 degree acute radioactive oral mucitis occurred)
- Comparison of quality of life(through study completion, an average of 5month)
研究者
Chen yuanyuan
Clinical Professor
Zhejiang Cancer Hospital