Interleukin-11 Can Prevent and Treat of Radioactive Oral Mucitis

Nasopharyngeal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03720340
• Other study ID #: IRB-2018-180
• Status: Recruiting
• Phase: Phase 3
• Start date: October 1, 2018
• Est. completion date: August 30, 2022

Study information

• Verified date: August 2020
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: August 30, 2022
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Nasopharyngeal Carcinoma

Intervention

Drug:
• Recombinant Human Interleukin-11
Recombinant Human Interleukin-11 was administed through respiratory tract.
• Saline
saline was administed through respiratory tract

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of severe acute radioactive oral mucitis	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).	through study completion, an average of 5mouth
Secondary	Comparison of the occurrence time of severe acute radioactive oral mucitis in two groups	RGOT/ CTCA	first day from radiation to the date 3 degree acute radioactive oral mucitis occurred
Secondary	last period of severe acute radioactive oral mucitis	RGOT/ CTCA	through study completion, an average of 5month
Secondary	Changes in oral flora	Changes in oral flora during treatments	through study completion, an average of 5month
Secondary	Changes in intestinal flora	Changes in oral intestinal during treatments	through study completion, an average of 5month
Secondary	Nutritional status	Nutrition Risk Screening NRS-2002 Assessment Comparison of Nutritional Status of Two Groups of Patients	through study completion, an average of 5month
Secondary	Comparison of quality of life	Life Quality Measurement Scale H&N35 Comparison of quality of life between two groups of patients	through study completion, an average of 5month