Nasopharyngeal Carcinoma
Conditions
Keywords
Nasopharyngeal Carcinoma, Acute Radiation Oral Mucositis, Recombinant human interleukin-11, oral microflora
Brief summary
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
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.
Interventions
DRUGRecombinant Human Interleukin-11
Recombinant Human Interleukin-11 was administed through respiratory tract.
DRUGSaline
saline was administed through respiratory tract
Sponsors
Zhejiang Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Clinical diagnosis of nasopharyngeal carcinoma. 2. 8th version American Joint Committee on Cancer (AJCC) stage I-IVB. 3. Age must beetween 18-75. 4. Performance status must be 0 or 1 according to Eastern Cooperative Oncology Group. 5. Adequate bone marrow, renal, and hepatic function.
Exclusion criteria
1. chemotherapy with fluorouracil drugs; Allergies to recombinant human interleukin-11. 2. Treatment with palliative intent.;Previous malignancy. 3. Pregnancy or lactation. 4. A history of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes. 5. Diabetes, oral mucositis and senile dry stomatitis. 6. Any severe coexisting disease.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of severe acute radioactive oral mucitis | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| last period of severe acute radioactive oral mucitis | through study completion, an average of 5month | RGOT/ CTCA |
| Changes in oral flora | through study completion, an average of 5month | Changes in oral flora during treatments |
| 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 | RGOT/ CTCA |
| Nutritional status | through study completion, an average of 5month | Nutrition Risk Screening NRS-2002 Assessment Comparison of Nutritional Status of Two Groups of Patients |
| Comparison of quality of life | through study completion, an average of 5month | Life Quality Measurement Scale H&N35 Comparison of quality of life between two groups of patients |
| Changes in intestinal flora | through study completion, an average of 5month | Changes in oral intestinal during treatments |
Countries
China
Outcome results
None listed