Interleukin-11 Can Prevent and Treat of Radioactive Oral Mucitis

NCT ID: NCT03720340

Last Updated: 2020-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2022-08-30

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.

Conditions

Nasopharyngeal Carcinoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Recombinant Human Interleukin-11

Intervention Type: DRUG

Recombinant Human Interleukin-11 was administed through respiratory tract.

Saline

Intervention Type: DRUG

saline was administed through respiratory tract

Saline

Only 10ml 0.9% NS was administered twicely to patients through respiratory tract.

Group Type: PLACEBO_COMPARATOR

Saline

Intervention Type: DRUG

saline was administed through respiratory tract

Interventions

Recombinant Human Interleukin-11

Recombinant Human Interleukin-11 was administed through respiratory tract.

Intervention Type: DRUG

Saline

saline was administed through respiratory tract

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhejiang Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chen yuanyuan

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Yuanyuan Chen, Professor

Role: primary

chenyy@zjcc.org.cn

+86 13738103808

Other Identifiers

IRB-2018-180

Identifier Type: -

Identifier Source: org_study_id