RecruitingNCT06700863

Screening of Biomarkers and Related Mechanisms for RIX

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


Sponsor

The First Affiliated Hospital with Nanjing Medical University

Enrollment

200 participants

Start Date

May 17, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is looking for biological markers (signals in blood or saliva) that predict which people with head and neck cancer will develop radiation-induced xerostomia — a severe dry mouth condition caused by radiation therapy. **You may be eligible if...** - You have been diagnosed with head and neck cancer confirmed by tissue biopsy - You are 18 or older - You are planning to have radiation treatment, either alone or combined with chemotherapy, immunotherapy, or targeted therapy **You may NOT be eligible if...** - Your cancer has already spread to distant parts of the body - You have had radiation to the head or neck area before - You already have severe dry mouth before starting treatment - You have advanced heart, kidney, or liver failure Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONRadiation Therapy

Radiotherapy for Head and Neck Cancer Patients


Locations(3)

Affiliated Jinling Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, China

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

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NCT06700863


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