NCT07170358 Screening of Biomarkers and Related Mechanisms for RIX
| NCT ID | NCT07170358 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Xerostomia Due to Radiotherapy (Disorder) |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2024-05-17 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2024-05-17 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07170358 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Xerostomia Due to Radiotherapy (Disorder). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07170358 currently recruiting?
Yes, NCT07170358 is actively recruiting participants. Contact the research team at ljin666666@zju.edu.cn for enrollment information.
Where is the NCT07170358 trial being conducted?
This trial is being conducted at Nanjing, China, Nanjing, China, Nanjing, China, Hangzhou, China.
Who is sponsoring the NCT07170358 clinical trial?
NCT07170358 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The trial plans to enroll 50 participants.