NCT04204382

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
144

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Dec 2019

Typical duration for phase_4

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

December 12, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

2.8 years

First QC Date

December 12, 2019

Last Update Submit

February 22, 2021

Conditions

Radiation-induced Oral Mucositis

Outcome Measures

Primary Outcomes (1)

  • 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%.

    From baseline to day 7.

Secondary Outcomes (7)

  • Oral pain score

    From baseline to day 7.

  • Completion of radiotherapy during concurrent radiotherapy

    From baseline to day 7.

  • Duration of interruption of radiotherapy

    From baseline to day 7.

  • Completion of chemotherapy during concurrent chemoradiotherapy

    From baseline to day 7.

  • Weight change

    From baseline to day 7.

  • +2 more secondary outcomes

Study Arms (2)

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,

Drug: Levofloxacin InjectionDrug: Compound Kushen Injection（CKI）

control group

OTHER

Levofloxacin injection were injected intravenously for 7 days, once a day, 0.5g each time.

Drug: Levofloxacin Injection

Interventions

Levofloxacin InjectionDRUG

Levofloxacin Injection 0.5 g each time, once a day, intravenous drip.Treatment course is 7 days.

Also known as: Zuoyangfushaxing Zhusheye
control grouptest group
Compound Kushen Injection（CKI）DRUG

CKI, 20mL each time, once a day, intravenous drip. Treatment course is 7 days.

Also known as: Yanshu injection
test group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Sun Yat-Sen Memorial Hospital Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

Yue Bei People's Hospital

Shaoguan, Guangdong, 512025, China

RECRUITING

Henan Anyang Tumor Hospital

Anyang, Henan, 455001, China

RECRUITING

Nanyang Central Hospital

Nanyang, Henan, 473009, China

RECRUITING

Zhenzhou Central Hospital

Zhenzhou, Henan, 450007, China

RECRUITING

Henan Cancer Hospital

Zhenzhou, Henan, 450008, China

RECRUITING

Affiliated Hospital of Jiangsu University

Nanjing, Jiangsu, 212000, China

RECRUITING

Liaoning Cancer Hospital & Institue

Shenyang, Liaoning, 110042, China

RECRUITING

Haici Medical Group

Qingdao, Shandong, 266034, China

RECRUITING

Weihai Municipal Hospital

Weihai, Shandong, 264200, China

RECRUITING

Second hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

RECRUITING

MeSH Terms

Interventions

Levofloxacin

Intervention Hierarchy (Ancestors)

OfloxacinFluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Xin-xin Zhang

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin-xin Zhang

CONTACT

15910520109xinxinzhang66@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2019

First Posted

December 19, 2019

Study Start

December 12, 2019

Primary Completion

September 30, 2022

Study Completion

December 30, 2022

Last Updated

February 25, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(12)