Screening of Biomarkers and Related Mechanisms for RIX

Официальное название

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

Обзор

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.

Вмешательства

• Лучевая терапия Radiation Therapy
  Radiotherapy for Head and Neck Cancer Patients

Первичные конечные точки

• Resting saliva flow measurement [Срок оценки: From the start of radiotherapy to 3 months after completion]

Вторичные конечные точки (2)

• Changes in Quality of Life and xerostomia Questionnaire Scores [Срок оценки: From the start of radiotherapy to 3 months after completion]
• Comparison of Body Mass Index [Срок оценки: From the start of radiotherapy to 3 months after completion]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 4 центра

• The First Affiliated Hospital of Nanjing Medical University — Нанкин
• Affiliated Jinling Hospital, Medical School of Nanjing University — Нанкин
• Jiangsu Cancer Hospital — Нанкин
• The Second Affiliated Hospital of Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT07170358 · 2025-0461

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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