Clinical Study On Acute Radiotherapy-Induced Oral Mucositis In Patients With Locally Advanced Head And Neck Tumors
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Jeksung combined with anti-radiation spray
Sponsored by
About this trial
This is an interventional treatment trial for Head and Neck Cancer
Eligibility Criteria
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.
Sites / Locations
- Yu Zeng
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Jeksung
Control
Arm Description
Outcomes
Primary Outcome Measures
Acute radiotherapy-induced oral mucositis
Occur rate of severe radiotherapy-induced oral mucositis
Secondary Outcome Measures
Oral pain
Utilization rate of analgesic drugs
Full Information
NCT ID
NCT05364918
First Posted
April 28, 2022
Last Updated
April 20, 2023
Sponsor
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
1. Study Identification
Unique Protocol Identification Number
NCT05364918
Brief Title
Clinical Study On Acute Radiotherapy-Induced Oral Mucositis In Patients With Locally Advanced Head And Neck Tumors
Official Title
Clinical Effect Of Application Of Jeksung Combined With Anti-radiation Spray In Patients Radiotherapy-Induced Oral Mucositis Of Local Advanced Head And Neck Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
August 17, 2020 (Actual)
Primary Completion Date
August 31, 2022 (Actual)
Study Completion Date
March 31, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Jeksung
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Jeksung combined with anti-radiation spray
Intervention Description
Treat radiation stomatitis with Jeksung combined with anti-radiation spray
Primary Outcome Measure Information:
Title
Acute radiotherapy-induced oral mucositis
Description
Occur rate of severe radiotherapy-induced oral mucositis
Time Frame
The first day of radiation therapy for head and neck tumors to the last day
Secondary Outcome Measure Information:
Title
Oral pain
Description
Utilization rate of analgesic drugs
Time Frame
The first day to the last day of radiation therapy for head and neck tumors
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Zeng, Dr.
Organizational Affiliation
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yu Zeng
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Study On Acute Radiotherapy-Induced Oral Mucositis In Patients With Locally Advanced Head And Neck Tumors
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