Clinical Study On Acute Radiotherapy-Induced Oral Mucositis In Patients With Locally Advanced Head And Neck Tumors

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

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.

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Drug: Jeksung combined with anti-radiation spray

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Yu Zeng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Head and neck cancer was confirmed by patholog
• Received radical radiotherapy, and were observed and treated by RTOM in the stomatology department
• Age range: 18-75 years old
• The estimated survival period is more than 6 months, and the card functional status score (KPS) is 70
• There are no diseases that affect the treatment of oral mucositis, such as mouth opening restriction, Sjogren's syndrome, etc.
• Sign the informed consent form

Exclusion Criteria:

• Failed to complete radiotherapy, or delayed radiotherapy more than 2 weeks than planned
• 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
• There are other diseases that affect radiotherapy, such as severe organ function injury, chronic infectious diseases, etc.
• Had received radiotherapy for head and neck for other diseases;
• The expected survival time is less than 6 months;
• Refuse to provide personal information or sign informed consent
• The investigator judged other conditions that might affect the conduct of the clinical study and the determination of the study results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Jeksung	Drug: Jeksung combined with anti-radiation spray; Treat radiation stomatitis with Jeksung combined with anti-radiation spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute radiotherapy-induced oral mucositis	Occur rate of severe radiotherapy-induced oral mucositis	The first day of radiation therapy for head and neck tumors to the last day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oral pain	Utilization rate of analgesic drugs	The first day to the last day of radiation therapy for head and neck tumors

Collaborators and Investigators

• Sponsor: Affiliated Cancer Hospital & Institute of Guangzhou Medical University
• Investigators: Principal Investigator: Yu Zeng, Dr., Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2020
• Primary Completion (Actual): August 31, 2022
• Study Completion (Actual): March 31, 2023

Study Registration Dates

• First Submitted: April 28, 2022
• First Submitted That Met QC Criteria: May 4, 2022
• First Posted (Actual): May 6, 2022

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Head and Neck Neoplasms; Mucositis; Stomatitis
• Other Study ID Numbers: Radioactive Oral Mucositis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No