Interleukin-11 Can Prevent and Treat of Radioactive Oral Mucitis

Sponsor

Zhejiang Cancer Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03720340

Collaborator

(none)

300

Enrollment

Location

Arms

46.9

Anticipated Duration (Months)

6.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Nasopharyngeal Carcinoma	Drug: Recombinant Human Interleukin-11 Drug: Saline	Phase 3

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 Design

Study Type:

Interventional

Anticipated Enrollment :

300 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Oct 1, 2018

Anticipated Primary Completion Date :

Aug 31, 2021

Anticipated Study Completion Date :

Aug 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Recombinant Human Interleukin-11 Recombinant Human Interleukin-11 was administed through respiratory tract. Drug: Saline saline was administed through respiratory tract
Placebo Comparator: Saline Only 10ml 0.9% NS was administered twicely to patients through respiratory tract.	Drug: Saline saline was administed through respiratory tract

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Recombinant Human Interleukin-11

Recombinant Human Interleukin-11 was administed through respiratory tract.

Drug: Saline

saline was administed through respiratory tract

Placebo Comparator: Saline

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

Drug: Saline

saline was administed through respiratory tract

Outcome Measures

Primary Outcome Measures

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

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
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
Changes in intestinal flora [through study completion, an average of 5month]
Changes in oral intestinal 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 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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Clinical diagnosis of nasopharyngeal carcinoma.
8th version American Joint Committee on Cancer (AJCC) stage I-IVB.
Age must beetween 18-75.
Performance status must be 0 or 1 according to Eastern Cooperative Oncology Group.
Adequate bone marrow, renal, and hepatic function.

Exclusion Criteria:

chemotherapy with fluorouracil drugs; Allergies to recombinant human interleukin-11.
Treatment with palliative intent.;Previous malignancy.
Pregnancy or lactation.
A history of previous radiotherapy, chemotherapy, or surgery (except diagnostic) to the primary tumor or nodes.
Diabetes, oral mucositis and senile dry stomatitis.
Any severe coexisting disease.