Screening of Diagnostic Biomarkers and Related Mechanisms for Radiation-induced Xerostomia

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Radiation
Study Type: Observational
SUMMARY

A large number of patients undergoing radiotherapy and chemotherapy are suffering from dry mouth. Due to reduced saliva secretion, patients may experience symptoms such as difficulty chewing and swallowing. In severe cases, they may also experience pain and burning sensation in the oral mucosa, decreased taste, ulcers, which seriously affect the quality of life of patients. However, radiation-induced dry mouth lacks early objective predictive indicators (molecular biomarkers) and the mechanism is unclear. Only when patients experience clinical symptoms will symptomatic treatment be taken to alleviate them. Therefore, elucidating the mechanism of radiation-induced dry mouth syndrome (RIX) and achieving early prediction, detection, and intervention of RIX are crucial in improving the prognosis and quality of life of radiotherapy patients. It is urgent to seek early and precise detection targets in clinical practice to predict dry mouth caused by irreversible damage to salivary gland tissue. This study aims to collect blood samples from patients with severe dry mouth before and after radiotherapy and chemotherapy in clinical practice. Multiple omics techniques will be used to search for predictive molecular biomarkers for RIX, construct a predictive model, and verify the sensitivity and specificity of the biomarkers. The goal is to predict the occurrence of RIX early in clinical practice, intervene in advance, greatly improve the prognosis of radiotherapy and chemotherapy patients, and enhance their quality of life.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: t
View:

• Histological diagnosis of head and neck cancer;

• Plan to undergo curative treatment with radiotherapy alone or in combination with synchronous chemotherapy, immunotherapy, or targeted therapy;

• Age greater than or equal to 18 years old, Fully understand the purpose and significance of this study, voluntarily participate and sign an informed consent form.

Locations
Other Locations
China
Affiliated Jinling Hospital, Medical School of Nanjing University
NOT_YET_RECRUITING
Nanjing
Jiangsu Cancer Hospital
RECRUITING
Nanjing
The First Affiliated Hospital of Nanjing Medical University
NOT_YET_RECRUITING
Nanjing
Contact Information
Primary
Lei Jin
ljin@nju.edu.cn
86+18951013666
Backup
mingzhe m xin
86+15249691991
Time Frame
Start Date: 2024-05-17
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 200
Treatments
No xerostomia before radiotherapy
Resting saliva flow rate greater than 1ml/10min before radiotherapy
Mild xerostomia during radiotherapy
During radiotherapy, a resting saliva flow rate between 0.5ml/10min-1ml/10min is considered mild dry mouth
Moderate to severe xerostomia during radiotherapy
A resting saliva flow rate below 0.5ml/10min during radiotherapy is considered moderate to severe xerostomia
Mild xerostomia after radiotherapy
After radiotherapy, a resting saliva flow rate between 0.5ml/10min-1ml/10min is considered mild dry mouth
Moderate to severe xerostomia xerostomia after radiotherapy
A resting saliva flow rate below 0.5ml/10min after radiotherapy is considered moderate to severe xerostomia
Related Therapeutic Areas
Sponsors
Collaborators: Jinling Hospital, China, Jiangsu Cancer Institute & Hospital
Leads: The First Affiliated Hospital with Nanjing Medical University

This content was sourced from clinicaltrials.gov