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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| test group | Experimental |
|
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| control group | Other | Levofloxacin injection were injected intravenously for 7 days, once a day, 0.5g each time. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levofloxacin Injection | Drug | Levofloxacin Injection 0.5 g each time, once a day, intravenous drip.Treatment course is 7 days. |
|
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin-xin Zhang | Contact | 15910520109 | xinxinzhang66@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Xin-xin Zhang | Chinese PLA General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chinese PLA General Hospital | Recruiting | Beijing | Beijing Municipality | 100853 | China |
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| ID | Term |
|---|---|
| D064704 | Levofloxacin |
| ID | Term |
|---|---|
| D015242 | Ofloxacin |
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
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| Compound Kushen Injection(CKI) | Drug | CKI, 20mL each time, once a day, intravenous drip. Treatment course is 7 days. |
|
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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. |
| Sun Yat-Sen Memorial Hospital Sun Yat-Sen University | Recruiting | Guangzhou | Guangdong | 510120 | China |
| Yue Bei People's Hospital | Recruiting | Shaoguan | Guangdong | 512025 | China |
| Henan Anyang Tumor Hospital | Recruiting | Anyang | Henan | 455001 | China |
| Nanyang Central Hospital | Recruiting | Nanyang | Henan | 473009 | China |
| Zhenzhou Central Hospital | Recruiting | Zhenzhou | Henan | 450007 | China |
| Henan Cancer Hospital | Recruiting | Zhenzhou | Henan | 450008 | China |
| Affiliated Hospital of Jiangsu University | Recruiting | Nanjing | Jiangsu | 212000 | China |
| Liaoning Cancer Hospital & Institue | Recruiting | Shenyang | Liaoning | 110042 | China |
| Haici Medical Group | Recruiting | Qingdao | Shandong | 266034 | China |
| Weihai Municipal Hospital | Recruiting | Weihai | Shandong | 264200 | China |
| Second hospital of Shanxi Medical University | Recruiting | Taiyuan | Shanxi | 030001 | China |
| D011804 |
| Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |