Screening of Biomarkers and Related Mechanisms for RIX

Nanjing Medical University

Status: Enrolling

Conditions: Xerostomia Due to Radiotherapy (Disorder)

Treatments: Radiation: Radiation Therapy

Study type: Observational

Funder types: Other

Identifiers

NCT06700863

2024-SR-545

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

200 participants in 5 patient groups

No xerostomia before radiotherapy

Description:

Resting saliva flow rate greater than 1ml/10min before radiotherapy

Mild xerostomia during radiotherapy

Description:

During radiotherapy, a resting saliva flow rate between 0.5ml/10min-1ml/10min is considered mild dry mouth

Treatment:

Radiation: Radiation Therapy

Moderate to severe xerostomia during radiotherapy

Description:

A resting saliva flow rate below 0.5ml/10min during radiotherapy is considered moderate to severe xerostomia

Treatment:

Radiation: Radiation Therapy

Mild xerostomia after radiotherapy

Description:

After radiotherapy, a resting saliva flow rate between 0.5ml/10min-1ml/10min is considered mild dry mouth

Treatment:

Radiation: Radiation Therapy

Moderate to severe xerostomia xerostomia after radiotherapy

Description:

A resting saliva flow rate below 0.5ml/10min after radiotherapy is considered moderate to severe xerostomia

Treatment:

Radiation: Radiation Therapy