Completed

Clinical Effect Of Application Of Jeksung Combined With Anti-radiation Spray In Patients Radiotherapy-Induced Oral Mucositis Of Local Advanced Head And Neck Tumors

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What is being tested

Jeksung combined with anti-radiation spray

Drug
Who is being recruted

Head and Neck Neoplasms

+ Neoplasms

+ Neoplasms by Site

From 18 to 75 Years
+13 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: August 2020
See protocol details

Summary

Principal SponsorAffiliated Cancer Hospital & Institute of Guangzhou Medical University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 17, 2020

Actual date on which the first participant was enrolled.

To explore a more efficient and scientific clinical treatment plan for acute radiotherapy-induced oral mucositis(RIOM/RTOM).it is hoped that the drug combination can more effectively improve the cure rate of acute RIOM,reduce the degree of oral mucosal injury and utilization rate of analgesic drugs,and reduce the occurrence of severe acute RIOM. Almost all patients with head and neck will have RIOM because of receiving radiation therapy.Studies have shown that the incidence of severe acute RIOM accounted for about 34% to 56%.There is no specific drug when acute RIOM is often accompanied by varying degrees of pain and infection in the mouth.Severe RIOM seriously affects ingestion through the mouth and doesn't conducive to the treatment and prognosis of tumor diseases. To further explore the efficiency and advantages of the combined application of Jeksung and anti-radiation spray in the treatment of acute RIOM at all levels,and provide more data support for relevant clinical treatment.Explore whether the Jeksung with combination of anti-radiation spray can effectively delay the occurrence of acute RIOM and delay the course of the disease.It will be expected to improve the quality of life of cancer patients ,reduce the occurrence of adverse events due during radiotherapy.

Official TitleClinical Effect Of Application Of Jeksung Combined With Anti-radiation Spray In Patients Radiotherapy-Induced Oral Mucositis Of Local Advanced Head And Neck Tumors
NCT05364918
Principal SponsorAffiliated Cancer Hospital & Institute of Guangzhou Medical University
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

100 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Head and Neck NeoplasmsNeoplasmsNeoplasms by Site

Criteria

6 inclusion criteria required to participate
The estimated survival period is more than 6 months, and the card functional status score (KPS) is 70

Age range: 18-75 years old

Received radical radiotherapy, and were observed and treated by RTOM in the stomatology department

Head and neck cancer was confirmed by patholog

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7 exclusion criteria prevent from participating
There are other diseases that affect radiotherapy, such as severe organ function injury, chronic infectious diseases, etc.

There are previous oral mucosal diseases, such as oral lichen planus and pemphigus, which are not effectively controlled or still need long-term drug treatment

The expected survival time is less than 6 months;

Failed to complete radiotherapy, or delayed radiotherapy more than 2 weeks than planned

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Yu Zeng

Guangzhou, ChinaOpen Yu Zeng in Google Maps
CompletedOne Study Center