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NCT07170358Recruiting

Screening of Biomarkers and Related Mechanisms for RIX

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

Source: ClinicalTrials.gov · Last updated 9 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
50 (estimated)
First submitted
7 Sept 2025
Start date
17 May 2024
Primary completion date
1 Dec 2026
Lead sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
NCT number
NCT07170358

What you commit to

  • Study type: Observational
  • Planned participants: 50
  • From 17 May 2024 to the primary completion date, 1 Dec 2026
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Severe dry mouth before radiotherapy;

Other illness

  • Metastatic diseases;
  • History of head and neck 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.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 75 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Second Affiliated Hospital of Zhejiang University School of Medicine
Coordinator of this site? Confirm its status
HangzhouChinaRecruiting
Affiliated Jinling Hospital, Medical School of Nanjing University
Coordinator of this site? Confirm its status
NanjingChinaRecruiting
Jiangsu Cancer Hospital
Coordinator of this site? Confirm its status
NanjingChinaRecruiting
The First Affiliated Hospital of Nanjing Medical University
Coordinator of this site? Confirm its status
NanjingChinaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.