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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
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 28, 2022
Last Updated
April 20, 2023
Sponsor
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
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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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