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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    144
  • sponsor
    Shanxi Zhendong Pharmacy Co., Ltd
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Updated on 21 February 2022
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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.

Description

Patients with oral mucositis caused by radiotherapy for Head and Neck Cancerwill 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 mucositisOral pain scoreCompletion and duration of interruption of radiotherapy Completion of chemotherapy during concurrent chemoradiotherapyweight changeFood 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.

Details
Condition Radiation-induced Oral Mucositis
Treatment Compound Kushen Injection, Levofloxacin injection, Compound Kushen Injection（CKI）
Clinical Study IdentifierNCT04204382
SponsorShanxi Zhendong Pharmacy Co., Ltd
Last Modified on21 February 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Patients are pathologically diagnosed as stage III or stage 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 8010^9/L, leukocytes 310^9/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
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