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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Recombinant human interleukin-11 | Active Comparator | 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. |
|
| Saline | Placebo Comparator | Only 10ml 0.9% NS was administered twicely to patients through respiratory tract. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Interleukin-11 | Drug | Recombinant Human Interleukin-11 was administed through respiratory tract. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Recruiting | Hangzhou | Zhejiang | 310022 | China |
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| ID | Term |
|---|---|
| D000077274 | Nasopharyngeal Carcinoma |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D017370 | Interleukin-11 |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007378 | Interleukins |
| D016207 | Cytokines |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
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| Saline | Drug | saline was administed through respiratory tract |
|
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 |
| D009303 |
| Nasopharyngeal Neoplasms |
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D000602 |
| Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |