Effects of CKI for Oral Mucositis Caused by Radiotherapy for Head and Neck Cancer
NCT ID: NCT04204382
Last Updated: 2021-02-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
144 participants
INTERVENTIONAL
2019-12-12
2022-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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test group
1. CKI was injected intravenously for 7 days, once a day, 20ml each time；
2. Levofloxacin injection were injected intravenously for 7 days, once a day, 0.5g each time,
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.
control group
Levofloxacin injection were injected intravenously for 7 days, once a day, 0.5g each time.
Levofloxacin Injection
Levofloxacin Injection 0.5 g each time, once a day, intravenous drip.Treatment course is 7 days.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
75 Years
ALL
No
Sponsors
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Shanxi Zhendong Pharmacy Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Xin-xin Zhang
Role: PRINCIPAL_INVESTIGATOR
Chinese PLA General Hospital
Locations
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Chinese PLA General Hospital
Beijing, Beijing Municipality, China
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
Guangzhou, Guangdong, China
Yue Bei People's Hospital
Shaoguan, Guangdong, China
Henan Anyang Tumor Hospital
Anyang, Henan, China
Nanyang Central Hospital
Nanyang, Henan, China
Zhenzhou Central Hospital
Zhenzhou, Henan, China
Henan Cancer Hospital
Zhenzhou, Henan, China
Affiliated Hospital of Jiangsu University
Nanjing, Jiangsu, China
Liaoning Cancer Hospital & Institue
Shenyang, Liaoning, China
Haici Medical Group
Qingdao, Shandong, China
Weihai Municipal Hospital
Weihai, Shandong, China
Second hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ZDKS-CP-180503-V1.1
Identifier Type: -
Identifier Source: org_study_id
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