Trials / Unknown
UnknownNCT04204382
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.
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- Sponsor
- Shanxi Zhendong Pharmacy Co., Ltd · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Levofloxacin Injection | Levofloxacin Injection 0.5 g each time, once a day, intravenous drip.Treatment course is 7 days. |
| DRUG | Compound Kushen Injection（CKI） | CKI, 20mL each time, once a day, intravenous drip. Treatment course is 7 days. |
Timeline
- Start date
- 2019-12-12
- Primary completion
- 2022-09-30
- Completion
- 2022-12-30
- First posted
- 2019-12-19
- Last updated
- 2021-02-25
Locations
12 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04204382. Inclusion in this directory is not an endorsement.