Effects of CKI for Oral Mucositis Caused by Radiotherapy for Head and Neck Cancer

Study Overview
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Brief Summary
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Oral mucositis (OM) is an acute side effect of radiotherapy for head and neck cancer (HNC). OM associated pain affects oral functions and nutrition of the patient that may result in discontinuity of treatment.The purpose of this clinical study is to evaluate the therapeutic effects of Compound Kushen Injection (CKI) on oral mucositis caused by radiotherapy of head and neck cancer.

Detailed Description
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Patients with oral mucositis caused by radiotherapy for Head and Neck Cancer，will be enrolled in the trial, then seprated randomly in two group,the experimental group treated with Levofloxacin injection plus CKI; the contral group treated with Levofloxacin injection only. Clinical grade of radioactive oral mucositis，Oral pain score，Completion and duration of interruption of radiotherapy， Completion of chemotherapy during concurrent chemoradiotherapy，weight change，Food intake (liquid food, semi liquid food)，recovery time of oral mucositis will be compared before treatment, 3 days, 5 days and 7 days after treatment between the experimental group and the control group.

Official Title
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Clinical Study of the Effects of Compound Kushen Injection on Radiation-induced Oral Mucositis in Head and Neck Cancer Patients.

Conditions
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Radiation-induced Oral Mucositis

Intervention / Treatment
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* Drug: Levofloxacin Injection
* Drug: Compound Kushen Injection（CKI）


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients are pathologically diagnosed as stage III or stage Ⅳ squamous cell carcinoma of head and neck cancer (including nasopharyngeal carcinoma)and are in accordance with the diagnostic criteria of radiotherapy induced mucositis/ stomatitis; Patients have no prior history of radiotherapy, and grade III oropharyngeal mucositis occured after the first radiotherapy; Patients have no stomatological diseases such as ulcer, edema and exudation in the oropharyngeal mucosa before radiotherapy; Eastern Cooperative Oncology Group (ECOG) performance Score is 0 or 1; The function of each organ is basically normal, including: hemoglobins ≥ 9g/dL, platelets ≥ 80×10^9/L, leukocytes ≥ 3×10^9/L, liver function within 3 times the upper normal limit, creatinine clearance ≥ 60mL/min; Patients aged between 18 and 75 years; Patients have a life expectancy of at least 6 months; Patients have fully understood the study and signed the informed consent voluntarily prior to any related procedures of the study. Exclusion Criteria: Patients who have received CoKS or systemic antibiotic treatment within 2 weeks before treatment; Patients who have a history of head or neck surgery (except biopsy); Female patients who are pregnant or breast feeding or female of pregnancy potential with a positive pregnancy test before treatment; Patients with serious or uncontrolled organic diseases or infections, such as decompensate cardiac function failure, pulmonary function failure, liver function failure, renal function failure, causing unability to tolerate radiotherapy; Patients who have radiotherapy contraindications; Patients who are allergic to the study medications or quinolones; Patients have serious psychological or psychiatric disorders, drug abuse or alcohol dependence in the past; Patients are currently participating in another clinical study or have participated in another clinical trial in the past 30 days; The investigator believes that it is not appropriate to participate in this trial.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: test group<br>CKI was injected intravenously for 7 days, once a day, 20ml each time； Levofloxacin injection were injected intravenously for 7 days, once a day, 0.5g each time, | Drug: Levofloxacin Injection<br>* Levofloxacin Injection 0.5 g each time, once a day, intravenous drip.Treatment course is 7 days.<br>* Other names: Zuoyangfushaxing Zhusheye;Drug: Compound Kushen Injection（CKI）<br>* CKI, 20mL each time, once a day, intravenous drip. Treatment course is 7 days.<br>* Other names: Yanshu injection;|
| Other: control group<br>Levofloxacin injection were injected intravenously for 7 days, once a day, 0.5g each time. | Drug: Levofloxacin Injection<br>* Levofloxacin Injection 0.5 g each time, once a day, intravenous drip.Treatment course is 7 days.<br>* Other names: Zuoyangfushaxing Zhusheye;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical grade of radioactive oral mucositis | Treatment efficacy measured by Chinese guideline Clinical diagnosis and treatment guidelines for tumor Significant: no leukoplakia or ulcer of the oral mucosa, mild hyperemia(grade Ⅰ), able to eat regular diet. Effective: moderate hyperemia of the oral mucosa, mild leukoplakia or patchy ulcerations(grade Ⅱ)，semi fluid intake, but not interfering with radiotherapy. Ineffective: severe hyperemia of the oral mucosa, flaked leukoplakia or ulcer (grade III or above), fluid intake，severe symptoms interfering with radiation therapy , intravascular nutrition or antibiotic treatment. Total effective rate = (significant + effective) / total cases × 100%. | From baseline to day 7. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral pain score | Oral pain are evaluated with Visual Analogue Score (VAS): 0 equal no pain and 10 equal worst imaginable pain. | From baseline to day 7. | 
| Completion of radiotherapy during concurrent radiotherapy | Compare the proportion of patients completing radiotherapy between the two groups. | From baseline to day 7. | 
| Duration of interruption of radiotherapy | Compare the days of interruption period of radiotherapy between the two groups. | From baseline to day 7. | 
| Completion of chemotherapy during concurrent chemoradiotherapy | Compare the proportion of patients whom complete chemotherapy between the two groups. | From baseline to day 7. | 
| Weight change | Compare the reduction in mean weight during radiotherapy between the two groups. | From baseline to day 7. | 
| Food intake (liquid food, semi liquid food) | Compare intake ability of food (liquid food, semi liquid food) between the two groups. Effective:dietary has improved (for example, changing from liquid food to semi liquid food, from semi liquid food to soft food, or from soft food to regular diet) Ineffective: the patients can not eat, or need tube feedings, or parenteral nutrition. | From baseline to day 7. | 
| Recovery time of oral mucositis | Recovery time，defined as the days needs for the clinical grade of oral mucositis to fall to grade II. | From baseline to day 7. |