Actively Recruiting

Age: 18Years - 75Years
All Genders
Healthy Volunteers
NCT07170358

Screening of Biomarkers and Related Mechanisms for RIX

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-09-12

126

Participants Needed

4

Research Sites

136 weeks

Total Duration

On this page

Sponsors

S

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead Sponsor

T

The Tumor Hospital of Jiangsu Province

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Screening of Biomarkers and Related Mechanisms for RIX

Who Can Participate

Age: 18Years - 75Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Histological diagnosis of head and neck cancer
  • Plan to receive curative radiotherapy alone or with synchronous chemotherapy, immunotherapy, or targeted therapy
  • Age 18 years or older
  • Fully understand the study purpose and voluntarily sign informed consent
Not Eligible

You will not qualify if you...

  • Presence of metastatic diseases
  • Previous radiotherapy to the head or neck
  • Severe dry mouth before starting radiotherapy
  • Advanced chronic diseases such as heart failure (New York Heart Association class III/IV), renal failure (eGFR under 30 mL/min/1.73m2), or liver failure (Child Pugh score C or D)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China, 210018

Not Yet Recruiting

2

Affiliated Jinling Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, China

Actively Recruiting

3

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Actively Recruiting

4

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Actively Recruiting

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Research Team

L

Lei Jin

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

5

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