Interleukin-11 Can Prevent and Treat of Radioactive Oral Mucitis

Phase 3UnknownNCT03720340

Zhejiang Cancer Hospital300 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

300

Conditions

Nasopharyngeal Carcinoma

Interventions

Recombinant Human Interleukin-11DRUG

Recombinant Human Interleukin-11 was administed through respiratory tract.

SalineDRUG

saline was administed through respiratory tract

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

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).

Time frame: through study completion, an average of 5mouth

Secondary Outcomes

Comparison of the occurrence time of severe acute radioactive oral mucitis in two groups

RGOT/ CTCA

Time frame: first day from radiation to the date 3 degree acute radioactive oral mucitis occurred

last period of severe acute radioactive oral mucitis

RGOT/ CTCA

Time frame: through study completion, an average of 5month

Changes in oral flora

Changes in oral flora during treatments

Time frame: through study completion, an average of 5month

Changes in intestinal flora

Changes in oral intestinal during treatments

Time frame: through study completion, an average of 5month

Nutritional status

Nutrition Risk Screening NRS-2002 Assessment Comparison of Nutritional Status of Two Groups of Patients

Time frame: through study completion, an average of 5month

Data from ClinicalTrials.gov

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