MedTrace Logo

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

NCT04204382 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2021-02-25

No results posted yet for this study

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.

Conditions

  • Radiation-induced Oral Mucositis

Interventions

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.

Sponsors & Collaborators

  • Shanxi Zhendong Pharmacy Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Xin-xin Zhang · Chinese PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-12
Primary Completion
2022-09-30
Completion
2022-12-30

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04204382 on ClinicalTrials.gov