An observational study in Xerostomia Due to Radiotherapy (Disorder), sponsored by The First Affiliated Hospital with Nanjing Medical University. Completed at 4 sites in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by The First Affiliated Hospital with Nanjing Medical University · Observational
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.
2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.
This study's enrollment of 100 is close to the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →The First Affiliated Hospital with Nanjing Medical University is the lead sponsor of 543 studies on the registry; 301 are open to participants now.
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Head and neck cancer radiotherapy patients
Exclusion Criteria:
Resting saliva flow rate greater than 1ml/10min before radiotherapy
During radiotherapy, a resting saliva flow rate between 0.5ml/10min-1ml/10min is considered mild dry mouth
Radiation: Radiation Therapy
A resting saliva flow rate below 0.5ml/10min during radiotherapy is considered moderate to severe xerostomia
Radiation: Radiation Therapy
After radiotherapy, a resting saliva flow rate between 0.5ml/10min-1ml/10min is considered mild dry mouth
Radiation: Radiation Therapy
A resting saliva flow rate below 0.5ml/10min after radiotherapy is considered moderate to severe xerostomia
Radiation: Radiation Therapy
Radiotherapy for Head and Neck Cancer Patients
Resting saliva flow measurement
When fasting in the morning, instruct the patient to gather saliva at the bottom of the mouth, lower their head and slightly open their mouth to allow the gathered saliva to naturally flow into the oral cup. Generally, collect for 10 minutes, with less than 1ml indicating mild dry mouth, less than 0.5ml indicating moderate dry mouth, and less than 0.1ml indicating severe dry mouth.
Time frame: From the start of radiotherapy to 3 months after completion
Changes in Quality of Life and xerostomia Questionnaire Scores
According to the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-head and neck35(EORTC QLQ-H\&N35) questionnaire, dry mouth symptoms were scored and classified in patients with postoperative oral dryness after radiotherapy.In the dry mouth category, responses of "quite a bit" and "very much" and a total score difference of ≥ 10 points before and after treatment are defined as moderate to severe dry mouth.The higher the overall score, the worse the situation.
Time frame: From the start of radiotherapy to 3 months after completion
Comparison of Body Mass Index
Measure the weight changes of patients before and after radiotherapy, weight and height will be combined to report BMI in kg/m\^2.
Time frame: From the start of radiotherapy to 3 months after completion
Plan to share: No
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The First Affiliated Hospital with Nanjing Medical University