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

  • STATUS
    Recruiting
  • End date
    Dec 30, 2022
  • participants needed
    144
  • sponsor
    Shanxi Zhendong Pharmacy Co., Ltd
Updated on 7 March 2021

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.

Description

Patients with oral mucositis caused by radiotherapy for Head and Neck Cancerwill 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 mucositisOral pain scoreCompletion and duration of interruption of radiotherapy Completion of chemotherapy during concurrent chemoradiotherapyweight changeFood 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.

Details
Condition Radiation Induced Oral Mucositis
Treatment Compound Kushen Injection, Levofloxacin injection, Compound Kushen Injection(CKI)
Clinical Study IdentifierNCT04204382
SponsorShanxi Zhendong Pharmacy Co., Ltd
Last Modified on7 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients are pathologically diagnosed as stage III or stage 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 8010^9/L, leukocytes 310^9/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

Exclusion Criteria

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
Clear my responses

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

0/250
Preferred Language
Other Language
Please verify that you are not a bot.

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note