Clinical trial · Observational
Screening of Biomarkers and Related Mechanisms for RIX
Screening of Diagnostic Biomarkers and Related Mechanisms for Radiation-induced Xerostomia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Xerostomia Due to Radiotherapy (Disorder) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- label
- No xerostomia before radiotherapy
- description
- Resting saliva flow rate greater than 1ml/10min before radiotherapy
- label
- Mild xerostomia during radiotherapy
- description
- During radiotherapy, a resting saliva flow rate between 0.5ml/10min-1ml/10min is considered mild dry mouth
- interventionNames
- Radiation: Radiation Therapy
- label
- Moderate to severe xerostomia during radiotherapy
- description
- A resting saliva flow rate below 0.5ml/10min during radiotherapy is considered moderate to severe xerostomia
- interventionNames
- Radiation: Radiation Therapy
- label
- Mild xerostomia after radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available