Identifying biomarkers for dry mouth caused by radiotherapy
Screening of Diagnostic Biomarkers and Related Mechanisms for Radiation-induced Xerostomia
The First Affiliated Hospital with Nanjing Medical University · NCT06700863
This study is trying to find signs that can predict dry mouth in patients getting radiation treatment for head and neck cancer, to help improve their quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University (other) |
| Drugs / interventions | chemotherapy, immunotherapy, radiation |
| Locations | 3 sites (Nanjing, Jiangsu and 2 other locations) |
| Trial ID | NCT06700863 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the mechanisms and biomarkers associated with xerostomia, or dry mouth, in patients undergoing radiotherapy for head and neck cancer. By focusing on patients who are about to receive curative treatment, the study seeks to identify early predictive indicators of radiation-induced dry mouth. The goal is to enhance early detection and intervention strategies, ultimately improving the quality of life for these patients. The study will involve collaboration among several prominent hospitals in Nanjing, Jiangsu.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a histological diagnosis of head and neck cancer who are planning to undergo radiotherapy.
Not a fit: Patients with metastatic diseases, prior head and neck radiotherapy, or severe dry mouth before treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection and management of dry mouth in patients undergoing radiotherapy, enhancing their quality of life.
How similar studies have performed: While the approach of identifying biomarkers for xerostomia is not widely tested, similar studies have shown promise in understanding radiation effects on salivary glands.
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 2 other locations
- Affiliated Jinling Hospital, Medical School of Nanjing University — Nanjing, Jiangsu, China (NOT_YET_RECRUITING)
- Jiangsu Cancer Hospital — Nanjing, Jiangsu, China (RECRUITING)
- The First Affiliated Hospital of Nanjing Medical University — Nanjing, Jiangsu, China (NOT_YET_RECRUITING)
Study contacts
- Study coordinator: Lei Jin
- Email: ljin@nju.edu.cn
- Phone: 86+18951013666
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.
Conditions: Xerostomia Due to Radiotherapy, Head and neck tumor, radiotherapy, biomarkers, xerostomia