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Oprelvekin

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.

Only 10ml 0.9% NS was administered twicely to patients through respiratory tract.

Recombinant Human Interleukin-11 was administed through respiratory tract.

Recombinant Human Interleukin-11

saline was administed through respiratory tract

Saline

Yuanyuan Chen, Professor

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.

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.

Interleukin-11 Can Prevent and Treat of Radioactive Oral Mucitis

The Open and Multi-center Phase III Clinical Study of Interleukin-11 in the Prevention and Treatment of Radioactive Oral Mucitis

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).

Changes in oral intestinal during treatments

Nutrition Risk Screening NRS-2002 Assessment Comparison of Nutritional Status of Two Groups of Patients

Life Quality Measurement Scale H\&N35 Comparison of quality of life between two groups of patients

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Interleukin-11 Can Prevent and Treat of Radioactive Oral Mucitis	NCT03720340	Nasopharyngeal ...	Recombinant Hum... Saline	18 Years - 75 Years	Zhejiang Cancer Hospital
Interleukin-11 Can Prevent and Treat of Radioactive Oral Mucitis	NCT03720340	Nasopharyngeal ...	Recombinant Hum... Saline	18 Years - 75 Years	Zhejiang Cancer Hospital

Spots Global Cancer Trial Database for oral microflora