Searching for molecular markers linked to radiation-caused dry mouth in head and neck cancer patients
Screening of Diagnostic Biomarkers and Related Mechanisms for Radiation-induced Xerostomia
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 |
|---|---|
| Enrollment | 126 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 4 sites (Nanjing, Jiangsu and 3 other locations) |
| Trial ID | NCT07170358 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Nanjing, Jiangsu and 3 other locations
- The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (Not_yet_recruiting)
- 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)
Study contacts
- Study coordinator: Lei Jin
- Email: ljin666666@zju.edu.cn
- Phone: 86+13868063666
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.