Back to resultsEffects of CKI for Oral Mucositis Caused by Radiotherapy for Head and Neck Cancer
Primary Purpose
Radiation-induced Oral Mucositis
Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Levofloxacin Injection
Compound Kushen Injection（CKI）
Sponsored by
About this trial
This is an interventional treatment trial for Radiation-induced Oral Mucositis
Eligibility Criteria
Inclusion Criteria:
- 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;
- 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 ≥ 80×10^9/L, leukocytes ≥ 3×10^9/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.
Sites / Locations
- Chinese PLA General HospitalRecruiting
- Sun Yat-Sen Memorial Hospital Sun Yat-Sen UniversityRecruiting
- Yue Bei People's HospitalRecruiting
- Henan Anyang Tumor HospitalRecruiting
- Nanyang Central HospitalRecruiting
- Zhenzhou Central HospitalRecruiting
- Henan Cancer HospitalRecruiting
- Affiliated Hospital of Jiangsu UniversityRecruiting
- Liaoning Cancer Hospital & InstitueRecruiting
- Haici Medical GroupRecruiting
- Weihai Municipal HospitalRecruiting
- Second hospital of Shanxi Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
test group
control group
Arm Description
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,
Levofloxacin injection were injected intravenously for 7 days, once a day, 0.5g each time.
Outcomes
Primary Outcome Measures
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%.
Secondary Outcome Measures
Oral pain score
Oral pain are evaluated with Visual Analogue Score (VAS): 0 equal no pain and 10 equal worst imaginable pain.
Completion of radiotherapy during concurrent radiotherapy
Compare the proportion of patients completing radiotherapy between the two groups.
Duration of interruption of radiotherapy
Compare the days of interruption period of radiotherapy between the two groups.
Completion of chemotherapy during concurrent chemoradiotherapy
Compare the proportion of patients whom complete chemotherapy between the two groups.
Weight change
Compare the reduction in mean weight during radiotherapy between the two groups.
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.
Recovery time of oral mucositis
Recovery time，defined as the days needs for the clinical grade of oral mucositis to fall to grade II.
Full Information
NCT ID
NCT04204382
First Posted
December 12, 2019
Last Updated
February 22, 2021
Sponsor
Shanxi Zhendong Pharmacy Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT04204382
Brief Title
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
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
December 12, 2019 (Actual)
Primary Completion Date
September 30, 2022 (Anticipated)
Study Completion Date
December 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanxi Zhendong Pharmacy Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation-induced Oral Mucositis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
144 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
test group
Arm Type
Experimental
Arm Description
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,
Arm Title
control group
Arm Type
Other
Arm Description
Levofloxacin injection were injected intravenously for 7 days, once a day, 0.5g each time.
Intervention Type
Drug
Intervention Name(s)
Levofloxacin Injection
Other Intervention Name(s)
Zuoyangfushaxing Zhusheye
Intervention Description
Levofloxacin Injection 0.5 g each time, once a day, intravenous drip.Treatment course is 7 days.
Intervention Type
Drug
Intervention Name(s)
Compound Kushen Injection（CKI）
Other Intervention Name(s)
Yanshu injection
Intervention Description
CKI, 20mL each time, once a day, intravenous drip. Treatment course is 7 days.
Primary Outcome Measure Information:
Title
Clinical grade of radioactive oral mucositis
Description
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%.
Time Frame
From baseline to day 7.
Secondary Outcome Measure Information:
Title
Oral pain score
Description
Oral pain are evaluated with Visual Analogue Score (VAS): 0 equal no pain and 10 equal worst imaginable pain.
Time Frame
From baseline to day 7.
Title
Completion of radiotherapy during concurrent radiotherapy
Description
Compare the proportion of patients completing radiotherapy between the two groups.
Time Frame
From baseline to day 7.
Title
Duration of interruption of radiotherapy
Description
Compare the days of interruption period of radiotherapy between the two groups.
Time Frame
From baseline to day 7.
Title
Completion of chemotherapy during concurrent chemoradiotherapy
Description
Compare the proportion of patients whom complete chemotherapy between the two groups.
Time Frame
From baseline to day 7.
Title
Weight change
Description
Compare the reduction in mean weight during radiotherapy between the two groups.
Time Frame
From baseline to day 7.
Title
Food intake (liquid food, semi liquid food)
Description
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.
Time Frame
From baseline to day 7.
Title
Recovery time of oral mucositis
Description
Recovery time，defined as the days needs for the clinical grade of oral mucositis to fall to grade II.
Time Frame
From baseline to day 7.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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;
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 ≥ 80×10^9/L, leukocytes ≥ 3×10^9/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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin-xin Zhang
Phone
15910520109
Email
xinxinzhang66@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xin-xin Zhang
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin-xin Zhang
Phone
15910520109
Email
xinxinzhang66@hotmail.com
Facility Name
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Name
Yue Bei People's Hospital
City
Shaoguan
State/Province
Guangdong
ZIP/Postal Code
512025
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Anyang Tumor Hospital
City
Anyang
State/Province
Henan
ZIP/Postal Code
455001
Country
China
Individual Site Status
Recruiting
Facility Name
Nanyang Central Hospital
City
Nanyang
State/Province
Henan
ZIP/Postal Code
473009
Country
China
Individual Site Status
Recruiting
Facility Name
Zhenzhou Central Hospital
City
Zhenzhou
State/Province
Henan
ZIP/Postal Code
450007
Country
China
Individual Site Status
Recruiting
Facility Name
Henan Cancer Hospital
City
Zhenzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Name
Affiliated Hospital of Jiangsu University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
212000
Country
China
Individual Site Status
Recruiting
Facility Name
Liaoning Cancer Hospital & Institue
City
Shenyang
State/Province
Liaoning
ZIP/Postal Code
110042
Country
China
Individual Site Status
Recruiting
Facility Name
Haici Medical Group
City
Qingdao
State/Province
Shandong
ZIP/Postal Code
266034
Country
China
Individual Site Status
Recruiting
Facility Name
Weihai Municipal Hospital
City
Weihai
State/Province
Shandong
ZIP/Postal Code
264200
Country
China
Individual Site Status
Recruiting
Facility Name
Second hospital of Shanxi Medical University
City
Taiyuan
State/Province
Shanxi
ZIP/Postal Code
030001
Country
China
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Effects of CKI for Oral Mucositis Caused by Radiotherapy for Head and Neck Cancer
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