Skip to main content
OpenTrials
Completed

NCT Number: NCT05364918

Clinical Study On Acute Radiotherapy-Induced Oral Mucositis In Patients With Locally 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Yu Zeng

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Jeksung combined with anti-radiation spray

Drug

Treat radiation stomatitis with Jeksung combined with anti-radiation spray

Primary outcomes

  1. Acute radiotherapy-induced oral mucositis

    Time frame: The first day of radiation therapy for head and neck tumors to the last day

    Occur rate of severe radiotherapy-induced oral mucositis

Secondary outcomes

  1. Oral pain

    Time frame: The first day to the last day of radiation therapy for head and neck tumors

    Utilization rate of analgesic drugs

Sponsors and collaborators

Lead sponsor

Affiliated Cancer Hospital & Institute of Guangzhou Medical University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
May 6, 2022
Registry last updated
Apr 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.