Radiation-induced Oral MucositisPhase 4NCT04204382
Effects of CKI for Oral Mucositis Caused by Radiotherapy for Head and Neck Cancer
A Phase 4 study testing Levofloxacin Injection and Compound Kushen Injection（CKI） in people with Radiation-induced Oral Mucositis, run by Shanxi Zhendong Pharmacy Co., Ltd at 12 sites in China.
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)… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Radiation-induced Oral Mucositis
- What is being tested?
- Levofloxacin Injection and Compound Kushen Injection（CKI）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 12 sitesChina
- Study dates
- 12 Dec 2019to 30 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
China12 sites, 12 recruiting
- Recruiting
Henan Anyang Tumor Hospital
Anyang, Henan, 455001
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Xin-xin Zhang, 15910520109, xinxinzhang66@hotmail.com
- Recruiting
Sun Yat-Sen Memorial Hospital Sun Yat-Sen University
Guangzhou, Guangdong, 510120
- Recruiting
Affiliated Hospital of Jiangsu University
Nanjing, Jiangsu, 212000
- Recruiting
Nanyang Central Hospital
Nanyang, Henan, 473009
- Recruiting
Haici Medical Group
Qingdao, Shandong, 266034
- Recruiting
Yue Bei People's Hospital
Shaoguan, Guangdong, 512025
- Recruiting
Liaoning Cancer Hospital & Institue
Shenyang, Liaoning, 110042
- Recruiting
Second hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
- Recruiting
Weihai Municipal Hospital
Weihai, Shandong, 264200
- Recruiting
Zhenzhou Central Hospital
Zhenzhou, Henan, 450007
- Recruiting
Henan Cancer Hospital
Zhenzhou, Henan, 450008
About this study
Official title: 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.
Read the 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.
- Conditions
- Radiation-induced Oral Mucositis
- Being tested
- Levofloxacin Injection, Compound Kushen Injection（CKI）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levofloxacin InjectionDrug
Also called Zuoyangfushaxing Zhusheye
Levofloxacin Injection 0.5 g each time, once a day, intravenous drip.Treatment course is 7 days.
Compound Kushen Injection（CKI）Drug
Also called Yanshu injection
CKI, 20mL each time, once a day, intravenous drip. Treatment course is 7 days.
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | 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, Receives: Drug: Levofloxacin Injection; Drug: Compound Kushen Injection（CKI） |
| control group | Other | Levofloxacin injection were injected intravenously for 7 days, once a day, 0.5g each time. Receives: Drug: Levofloxacin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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%.
Measured: From baseline to day 7.
Secondary outcomes (7)
Oral pain score
Oral pain are evaluated with Visual Analogue Score (VAS): 0 equal no pain and 10 equal worst imaginable pain.
Measured: From baseline to day 7.
Completion of radiotherapy during concurrent radiotherapy
Compare the proportion of patients completing radiotherapy between the two groups.
Measured: From baseline to day 7.
Duration of interruption of radiotherapy
Compare the days of interruption period of radiotherapy between the two groups.
Measured: From baseline to day 7.
Completion of chemotherapy during concurrent chemoradiotherapy
Compare the proportion of patients whom complete chemotherapy between the two groups.
Measured: From baseline to day 7.
Weight change
Compare the reduction in mean weight during radiotherapy between the two groups.
Measured: 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.
Measured: 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.
Measured: From baseline to day 7.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start12 Dec 2019
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation-induced Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanxi Zhendong Pharmacy Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xin-xin Zhang, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204382
- Sponsor's protocol ID
- ZDKS-CP-180503-V1.1
- Status last verified
- Feb 2021
- First submitted
- 12 Dec 2019
- Last updated
- 25 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of the Effects of Compound Kushen Injection on Radiation-induced Oral Mucositis in Head and Neck Cancer Patients.
- ClinicalTrials.gov ID
- NCT04204382
- Acronym / sponsor ID
- ZDKS-CP-180503-V1.1
- Conditions
- Radiation-induced Oral Mucositis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Shanxi Zhendong Pharmacy Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 19 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Drug: Levofloxacin Injection, Drug: Compound Kushen Injection（CKI）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, |
| control group | Other | Drug: Levofloxacin InjectionLevofloxacin injection were injected intravenously for 7 days, once a day, 0.5g each time. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levofloxacin InjectionAlso: Zuoyangfushaxing ZhusheyeLevofloxacin Injection 0.5 g each time, once a day, intravenous drip.Treatment course is 7 days. | Drug | control group, test group |
| Compound Kushen Injection（CKI）Also: Yanshu injectionCKI, 20mL each time, once a day, intravenous drip. Treatment course is 7 days. | Drug | test group |
Primary outcome
Clinical grade of radioactive oral mucositis
Time frame: From baseline to day 7.
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%.
7 secondary outcomes
Oral pain score
Time frame: From baseline to day 7.
Completion of radiotherapy during concurrent radiotherapy
Time frame: From baseline to day 7.
Duration of interruption of radiotherapy
Time frame: From baseline to day 7.
Completion of chemotherapy during concurrent chemoradiotherapy
Time frame: From baseline to day 7.
Weight change
Time frame: From baseline to day 7.
Food intake (liquid food, semi liquid food)
Time frame: From baseline to day 7.
Recovery time of oral mucositis
Time frame: From baseline to day 7.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xin-xin Zhang principal investigator
Chinese PLA General Hospital
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Levofloxacin Injection and Compound Kushen Injection（CKI） in people with Radiation-induced Oral Mucositis, run by Shanxi Zhendong Pharmacy Co., Ltd at 12 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin-xin Zhang (15910520109, xinxinzhang66@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical grade of radioactive oral mucositis (time frame: From baseline to day 7.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2021.