Interleukin-11 Can Prevent and Treat of Radioactive Oral Mucitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Nasopharyngeal Carcinoma

Intervention / Treatment
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* Drug: Recombinant Human Interleukin-11
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of nasopharyngeal carcinoma. 8th version American Joint Committee on Cancer (AJCC) stage I-IVB. Age must beetween 18-75. Performance status must be 0 or 1 according to Eastern Cooperative Oncology Group. Adequate bone marrow, renal, and hepatic function. Exclusion Criteria: chemotherapy with fluorouracil drugs; Allergies to recombinant human interleukin-11. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Recombinant human interleukin-11<br>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. | Drug: Recombinant Human Interleukin-11<br>* Recombinant Human Interleukin-11 was administed through respiratory tract.<br>Drug: Saline<br>* saline was administed through respiratory tract<br>|
| Placebo Comparator: Saline<br>Only 10ml 0.9% NS was administered twicely to patients through respiratory tract. | Drug: Saline<br>* saline was administed through respiratory tract<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of severe acute 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). | through study completion, an average of 5mouth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the occurrence time of severe acute radioactive oral mucitis in two groups | RGOT/ CTCA | first day from radiation to the date 3 degree acute radioactive oral mucitis occurred | 
| last period of severe acute radioactive oral mucitis | RGOT/ CTCA | through study completion, an average of 5month | 
| Changes in oral flora | Changes in oral flora during treatments | through study completion, an average of 5month | 
| Changes in intestinal flora | Changes in oral intestinal during treatments | through study completion, an average of 5month | 
| Nutritional status | Nutrition Risk Screening NRS-2002 Assessment Comparison of Nutritional Status of Two Groups of Patients | through study completion, an average of 5month | 
| Comparison of quality of life | Life Quality Measurement Scale H&N35 Comparison of quality of life between two groups of patients | through study completion, an average of 5month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasopharyngeal Carcinoma, Acute Radiation Oral Mucositis, Recombinant human interleukin-11, oral microflora