Clinical trial NCT04204382: Effects of CKI for Oral Mucositis Caused by Radiotherapy for Head and Neck Cancer
Official title: Clinical Study of the Effects of Compound Kushen Injection on Radiation-induced Oral Mucositis in Head and Neck Cancer Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Radiation-induced Oral Mucositis
Lead sponsor: Shanxi Zhendong Pharmacy Co., Ltd
Sponsor class: INDUSTRY
First posted: 2019-12-19
Enrollment: 144
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. Patients have no prior history of radiotherapy, and grade III oropharyngeal mucositis occured after the first radiotherapy;
3. Patients have no stomatological diseases such as ulcer, edema and exudation in the oropharyngeal mucosa before radiotherapy;
4. Eastern Cooperative Oncology Group (ECOG) performance Score is 0 or 1;
5. 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;
6. Patients aged between 18 and 75 years;
7. Patients have a life expectancy of at least 6 months;
8. Patients have fully understood the study and signed the informed consent voluntarily prior to any related procedures of the study.

Exclusion Criteria:

1. Patients who have received CoKS or systemic antibiotic treatment within 2 weeks before treatment;
2. Patients who have a history of head or neck surgery (except biopsy);
3. Female patients who are pregnant or breast feeding or female of pregnancy potential with a positive pregnancy test before treatment;
4. 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;
5. Patients who have radiotherapy contraindications;
6. Patients who are allergic to the study medications or quinolones;
7. Patients have serious psychological or psychiatric disorders, drug abuse or alcohol dependence in the past;
8. Patients are currently participating in another clinical study or have participated in another clinical trial in the past 30 days;
9. The investigator believes that it is not appropriate to participate in this trial.

Primary outcomes:
measure: Clinical grade of radioactive oral mucositis
timeFrame: From baseline to day 7.
Secondary outcomes:
measure: Oral pain score
timeFrame: From baseline to day 7.
measure: Completion of radiotherapy during concurrent radiotherapy
timeFrame: From baseline to day 7.
measure: Duration of interruption of radiotherapy
timeFrame: From baseline to day 7.
measure: Completion of chemotherapy during concurrent chemoradiotherapy
timeFrame: From baseline to day 7.
measure: Weight change
timeFrame: From baseline to day 7.
measure: Food intake (liquid food, semi liquid food)
timeFrame: From baseline to day 7.
measure: Recovery time of oral mucositis
timeFrame: From baseline to day 7.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
state: Guangdong
city: Shaoguan
country: China
facility: Yue Bei People's Hospital
state: Guangdong
city: Anyang
country: China
facility: Henan Anyang Tumor Hospital
state: Henan
city: Nanyang
country: China
facility: Nanyang Central Hospital
state: Henan
city: Zhenzhou
country: China
facility: Zhenzhou Central Hospital
state: Henan
city: Zhenzhou
country: China
facility: Henan Cancer Hospital
state: Henan
city: Nanjing
country: China
facility: Affiliated Hospital of Jiangsu University
state: Jiangsu
city: Shenyang
country: China
facility: Liaoning Cancer Hospital & Institue
state: Liaoning
city: Qingdao
country: China
facility: Haici Medical Group
state: Shandong
city: Weihai
country: China
facility: Weihai Municipal Hospital
state: Shandong
city: Taiyuan
country: China
facility: Second hospital of Shanxi Medical University
state: Shanxi
Study officials:
affiliation: Chinese PLA General Hospital
name: Xin-xin Zhang
role: PRINCIPAL_INVESTIGATOR
References: