Screening of Biomarkers and Related Mechanisms for RIX
RIX
Screening of Diagnostic Biomarkers and Related Mechanisms for Radiation-induced Xerostomia
1 other identifier
observational
200
1 country
3
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2024
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 17, 2024
CompletedFirst Submitted
Initial submission to the registry
September 19, 2024
CompletedFirst Posted
Study publicly available on registry
November 22, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedNovember 22, 2024
November 1, 2024
1.1 years
September 19, 2024
November 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Resting saliva flow measurement
When fasting in the morning, instruct the patient to gather saliva at the bottom of the mouth, lower their head and slightly open their mouth to allow the gathered saliva to naturally flow into the oral cup. Generally, collect for 10 minutes, with less than 1ml indicating mild dry mouth, less than 0.5ml indicating moderate dry mouth, and less than 0.1ml indicating severe dry mouth.
From the start of radiotherapy to 3 months after completion
Secondary Outcomes (2)
Changes in Quality of Life and xerostomia Questionnaire Scores
From the start of radiotherapy to 3 months after completion
Comparison of Body Mass Index
From the start of radiotherapy to 3 months after completion
Study Arms (5)
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
Interventions
Radiotherapy for Head and Neck Cancer Patients
Eligibility Criteria
Head and neck cancer radiotherapy patients
You may qualify if:
- 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.
You may not qualify if:
- Metastatic diseases;
- History of head and neck radiotherapy;
- Severe dry mouth before radiotherapy;
- Suffering from advanced chronic diseases: heart failure - New York Heart Association functional classification III/IV, renal failure - estimated glomerular filtration rate under 30mL/min/1.73m2, liver failure - Child Pugh score C or D.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Affiliated Jinling Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 450041, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Biospecimen
Plasma, serum, blood cells
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2024
First Posted
November 22, 2024
Study Start
May 17, 2024
Primary Completion
July 1, 2025
Study Completion
December 31, 2025
Last Updated
November 22, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share