Clinical trial NCT03720340: Interleukin-11 Can Prevent and Treat of Radioactive Oral Mucitis
Official title: The Open and Multi-center Phase III Clinical Study of Interleukin-11 in the Prevention and Treatment of Radioactive Oral Mucitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Nasopharyngeal Carcinoma
Keywords: Nasopharyngeal Carcinoma
Acute Radiation Oral Mucositis
Recombinant human interleukin-11
oral microflora
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2018-10-25
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of severe acute radioactive oral mucitis
timeFrame: through study completion, an average of 5mouth
Secondary outcomes:
measure: Comparison of the occurrence time of severe acute radioactive oral mucitis in two groups
timeFrame: first day from radiation to the date 3 degree acute radioactive oral mucitis occurred
measure: last period of severe acute radioactive oral mucitis
timeFrame: through study completion, an average of 5month
measure: Changes in oral flora
timeFrame: through study completion, an average of 5month
measure: Changes in intestinal flora
timeFrame: through study completion, an average of 5month
measure: Nutritional status
timeFrame: through study completion, an average of 5month
measure: Comparison of quality of life
timeFrame: through study completion, an average of 5month
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
References: