Overview

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

Status:
Recruiting

Trial end date:
2022-12-30

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Shanxi Zhendong Pharmacy Co., Ltd

Treatments:

Levofloxacin
Ofloxacin

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.