Screening of Biomarkers and Related Mechanisms for RIX

Recruiting

• Conditions: Xerostomia Due to Radiotherapy (Disorder)

• Registration Number: NCT06700863
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-05-17
• Study First Submitted: 2024-09-19
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-20
• Last Update Submitted: 2024-11-20
• Study First Posted: 2024-11-22
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-07-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Resting saliva flow measurement	From the start of radiotherapy to 3 months after completion	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.

Secondary Outcome Measures

Name	Time	Method
Changes in Quality of Life and xerostomia Questionnaire Scores	From the start of radiotherapy to 3 months after completion	According to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-head and neck35(EORTC QLQ-H\&N35) questionnaire, dry mouth symptoms were scored and classified in patients with postoperative oral dryness after radiotherapy.In the dry mouth category, responses of "quite a bit" and "very much" and a total score difference of ≥ 10 points before and after treatment are defined as moderate to severe dry mouth.The higher the overall score, the worse the situation.
Comparison of Body Mass Index	From the start of radiotherapy to 3 months after completion	Measure the weight changes of patients before and after radiotherapy, weight and height will be combined to report BMI in kg/m\^2.

Trial Locations

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