Interleukin-11 Can Prevent and Treat of Radioactive Oral Mucitis

Phase 3

• Conditions: Nasopharyngeal Carcinoma
• Interventions: Drug: Recombinant Human Interleukin-11; Drug: Saline

• Registration Number: NCT03720340
• Lead Sponsor: Zhejiang Cancer Hospital

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.

Study Timeline

• Study Start: 2018-10-01
• Study First Submitted: 2018-10-10
• Study First Submitted QC: 2018-10-24
• Study First Posted: 2018-10-25
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-11
• Primary Completion: 2021-08-31
• Study Completion: 2022-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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.
Saline	Saline	Only 10ml 0.9% NS was administered twicely to patients through respiratory tract.
Recombinant human interleukin-11	Saline	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.

Primary Outcome Measures

Name	Time	Method
Incidence of severe acute radioactive oral mucitis	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 Outcome Measures

Name	Time	Method
Changes in intestinal flora	through study completion, an average of 5month	Changes in oral intestinal during treatments
last period of severe acute radioactive oral mucitis	through study completion, an average of 5month	RGOT/ CTCA
Changes in oral flora	through study completion, an average of 5month	Changes in oral flora during treatments
Nutritional status	through study completion, an average of 5month	Nutrition Risk Screening NRS-2002 Assessment Comparison of Nutritional Status of Two Groups of Patients
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	RGOT/ CTCA
Comparison of quality of life	through study completion, an average of 5month	Life Quality Measurement Scale H\&N35 Comparison of quality of life between two groups of patients

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China