The Open and Multi-center Phase III Clinical Study of Interleukin-11 in the Prevention and Treatment of Radioactive Oral Mucitis
Overview
- Phase
- Phase 3
- Intervention
- Recombinant Human Interleukin-11
- Conditions
- Nasopharyngeal Carcinoma
- Sponsor
- Zhejiang Cancer Hospital
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- Incidence of severe acute radioactive oral mucitis
- Last Updated
- 5 years ago
Overview
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.
Investigators
Chen yuanyuan
Clinical Professor
Zhejiang Cancer Hospital
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: Recombinant Human Interleukin-11
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.
Intervention: Saline
Saline
Only 10ml 0.9% NS was administered twicely to patients through respiratory tract.
Intervention: Saline
Outcomes
Primary Outcomes
Incidence of severe acute radioactive oral mucitis
Time Frame: 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 Outcomes
- 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)