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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Radiation-induced Oral Mucositis
• Intervention / Treatment: Drug: Levofloxacin Injection; Drug: Compound Kushen Injection（CKI）

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.

• Study Type: Interventional
• Enrollment (Anticipated): 144
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Xin-xin Zhang; Phone Number: 15910520109; Email: xinxinzhang66@hotmail.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100853
      • Recruiting
      • Chinese PLA General Hospital
      • Contact: Xin-xin Zhang; Phone Number: 15910520109; Email: xinxinzhang66@hotmail.com
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • Sun Yat-Sen Memorial Hospital Sun Yat-sen University
    • Shaoguan, Guangdong, China, 512025
      • Recruiting
      • Yue Bei People's Hospital
  • Henan
    • Anyang, Henan, China, 455001
      • Recruiting
      • Henan Anyang Tumor Hospital
    • Nanyang, Henan, China, 473009
      • Recruiting
      • Nanyang Central Hospital
    • Zhenzhou, Henan, China, 450007
      • Recruiting
      • ZhenZhou Central Hospital
    • Zhenzhou, Henan, China, 450008
      • Recruiting
      • Henan cancer hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 212000
      • Recruiting
      • Affiliated Hospital of Jiangsu University
  • Liaoning
    • Shenyang, Liaoning, China, 110042
      • Recruiting
      • Liaoning Cancer Hospital & Institue
  • Shandong
    • Qingdao, Shandong, China, 266034
      • Recruiting
      • Haici Medical Group
    • Weihai, Shandong, China, 264200
      • Recruiting
      • Weihai Municipal Hospital
  • Shanxi
    • Taiyuan, Shanxi, China, 030001
      • Recruiting
      • Second Hospital of Shanxi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: test group; CKI was injected intravenously for 7 days, once a day, 20ml each time；; Levofloxacin injection were injected intravenously for 7 days, once a day, 0.5g each time,	Drug: Levofloxacin Injection; Levofloxacin Injection 0.5 g each time, once a day, intravenous drip.Treatment course is 7 days.; Other Names: Zuoyangfushaxing Zhusheye; Drug: Compound Kushen Injection（CKI）; CKI, 20mL each time, once a day, intravenous drip. Treatment course is 7 days.; Other Names: Yanshu injection
Other: control group; Levofloxacin injection were injected intravenously for 7 days, once a day, 0.5g each time.	Drug: Levofloxacin Injection; Levofloxacin Injection 0.5 g each time, once a day, intravenous drip.Treatment course is 7 days.; Other Names: Zuoyangfushaxing Zhusheye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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.

Collaborators and Investigators

• Sponsor: Shanxi Zhendong Pharmacy Co., Ltd
• Investigators: Principal Investigator: Xin-xin Zhang, Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2019
• Primary Completion (Anticipated): September 30, 2022
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: December 12, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 19, 2019

Study Record Updates

• Last Update Posted (Actual): February 25, 2021
• Last Update Submitted That Met QC Criteria: February 22, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Head and Neck Neoplasms; Mucositis; Stomatitis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antineoplastic Agents; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 Enzyme Inhibitors; Cytochrome P-450 CYP1A2 Inhibitors; Anti-Infective Agents, Urinary; Renal Agents; Levofloxacin; Ofloxacin
• Other Study ID Numbers: ZDKS-CP-180503-V1.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No