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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
144
Levofloxacin Injection 0.5 g each time, once a day, intravenous drip.Treatment course is 7 days.
CKI, 20mL each time, once a day, intravenous drip. Treatment course is 7 days.
Chinese PLA General Hospital
Beijing, Beijing Municipality, China
RECRUITINGSun Yat-Sen Memorial Hospital Sun Yat-Sen University
Guangzhou, Guangdong, China
RECRUITINGClinical 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%.
Time frame: From baseline to day 7.
Oral pain score
Oral pain are evaluated with Visual Analogue Score (VAS): 0 equal no pain and 10 equal worst imaginable pain.
Time frame: From baseline to day 7.
Completion of radiotherapy during concurrent radiotherapy
Compare the proportion of patients completing radiotherapy between the two groups.
Time frame: From baseline to day 7.
Duration of interruption of radiotherapy
Compare the days of interruption period of radiotherapy between the two groups.
Time frame: From baseline to day 7.
Completion of chemotherapy during concurrent chemoradiotherapy
Compare the proportion of patients whom complete chemotherapy between the two groups.
Time frame: From baseline to day 7.
Weight change
Compare the reduction in mean weight during radiotherapy between the two groups.
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Yue Bei People's Hospital
Shaoguan, Guangdong, China
RECRUITINGHenan Anyang Tumor Hospital
Anyang, Henan, China
RECRUITINGNanyang Central Hospital
Nanyang, Henan, China
RECRUITINGZhenzhou Central Hospital
Zhenzhou, Henan, China
RECRUITINGHenan Cancer Hospital
Zhenzhou, Henan, China
RECRUITINGAffiliated Hospital of Jiangsu University
Nanjing, Jiangsu, China
RECRUITINGLiaoning Cancer Hospital & Institue
Shenyang, Liaoning, China
RECRUITINGHaici Medical Group
Qingdao, Shandong, China
RECRUITING...and 2 more locations
Time frame: 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.
Time frame: 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.
Time frame: From baseline to day 7.