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

Radiation-induced Oral Mucositis Clinical Trial

Official title:

Clinical Study of the Effects of Compound Kushen Injection on Radiation-induced Oral Mucositis in Head and Neck Cancer Patients.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04204382
• Other study ID #: ZDKS-CP-180503-V1.1
• Status: Recruiting
• Phase: Phase 4
• Start date: December 12, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: February 2021
• Source: Shanxi Zhendong Pharmacy Co., Ltd
• Contact: Xin-xin Zhang
• Phone: 15910520109
• Email: xinxinzhang66[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 144
• Est. completion date: December 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 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;

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.

Related Conditions & MeSH terms

• Head and Neck Neoplasms
• Mucositis
• Radiation-induced Oral Mucositis
• Stomatitis

Intervention

Drug:
• Levofloxacin Injection
Levofloxacin Injection 0.5 g each time, once a day, intravenous drip.Treatment course is 7 days.
• Compound Kushen Injection(CKI)
CKI, 20mL each time, once a day, intravenous drip. Treatment course is 7 days.

Locations

Country	Name	City	State
China	Henan Anyang Tumor Hospital	Anyang	Henan
China	Chinese PLA General Hospital	Beijing	Beijing
China	Sun Yat-Sen Memorial Hospital Sun Yat-Sen University	Guangzhou	Guangdong
China	Affiliated Hospital of Jiangsu University	Nanjing	Jiangsu
China	Nanyang Central Hospital	Nanyang	Henan
China	Haici Medical Group	Qingdao	Shandong
China	Yue Bei People's Hospital	Shaoguan	Guangdong
China	Liaoning Cancer Hospital & Institue	Shenyang	Liaoning
China	Second hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Weihai Municipal Hospital	Weihai	Shandong
China	Henan Cancer Hospital	Zhenzhou	Henan
China	Zhenzhou Central Hospital	Zhenzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
Shanxi Zhendong Pharmacy Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ?), able to eat regular diet.; Effective: moderate hyperemia of the oral mucosa, mild leukoplakia or patchy ulcerations(grade ?),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.
Secondary	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.
Secondary	Completion of radiotherapy during concurrent radiotherapy	Compare the proportion of patients completing radiotherapy between the two groups.	From baseline to day 7.
Secondary	Duration of interruption of radiotherapy	Compare the days of interruption period of radiotherapy between the two groups.	From baseline to day 7.
Secondary	Completion of chemotherapy during concurrent chemoradiotherapy	Compare the proportion of patients whom complete chemotherapy between the two groups.	From baseline to day 7.
Secondary	Weight change	Compare the reduction in mean weight during radiotherapy between the two groups.	From baseline to day 7.
Secondary	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.
Secondary	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.