Searching for molecular markers linked to radiation-caused dry mouth in head and neck cancer patients
Official title: Screening of Diagnostic Biomarkers and Related Mechanisms for Radiation-induced Xerostomia
Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT07170358 · Data updated 2026-11-12
This project will try to find blood, saliva, or tissue markers in adults with head and neck cancer getting radiotherapy to see if those markers can predict who will develop dry mouth.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 4 sites (Nanjing, Jiangsu and 3 other locations) |
| Status | Recruiting |
| Started | May 17, 2024 |
| Main results expected | December 1, 2026 |
| Study ends | June 30, 2027 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT07170358 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are adults with confirmed head and neck cancer who are planning curative-intent radiotherapy (with or without systemic therapy), can give informed consent, and do not have prior head and neck radiotherapy or metastatic disease.
✕Probably not a fit
Patients with metastatic disease, prior head and neck radiotherapy, or severe preexisting dry mouth are unlikely to benefit from the predictive goals of this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational study enrolling adults with histologically confirmed head and neck cancer who are planned for curative radiotherapy with or without concurrent chemotherapy, immunotherapy, or targeted therapy. Researchers will collect clinical data and biological samples (for example blood, saliva, and possibly tissue) before, during, and after radiotherapy to screen for molecular biomarkers associated with radiation-induced xerostomia. Patients will be followed for onset and severity of dry mouth symptoms and objective measures of salivary function, and biomarker levels will be correlated with clinical outcomes. The study also aims to explore biological pathways that link radiation exposure to salivary gland injury to support early prediction and intervention strategies.
Why it matters
Potential benefit: If successful, the findings could enable earlier prediction of radiation-induced dry mouth so clinicians can intervene sooner to preserve salivary function and quality of life.
How similar studies have gone: Previous research has identified candidate salivary and blood markers and implicated inflammatory and glandular pathways, but robust early predictive biomarkers for radiation-induced dry mouth remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
Affiliated Jinling Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, China Recruiting -
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China Recruiting -
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China Recruiting -
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China Not yet recruiting
Study contacts
- Study coordinator: Lei Jin
- Email: ljin666666@zju.edu.cn
- Phone: 86+13868063666
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Comparing two types of radiotherapy for nasopharyngeal carcinoma
This study is testing if a special type of radiotherapy that protects the salivary glands can help people with nasopharyngeal cancer feel better and live longer compared to standard radiotherapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.