NCT03720340

Interleukin-11 Can Prevent and Treat of Radioactive Oral Mucitis

The Open and Multi-center Phase III Clinical Study of Interleukin-11 in the Prevention and Treatment of Radioactive Oral Mucitis

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Zhejiang Cancer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Recombinant Human Interleukin-11	Recombinant Human Interleukin-11 was administed through respiratory tract.
DRUG	Saline	saline was administed through respiratory tract

Timeline

• Start date: 2018-10-01
• Primary completion: 2021-08-31
• Completion: 2022-08-30
• First posted: 2018-10-25
• Last updated: 2020-08-11

Locations

1 site across 1 country: China