Clinical trial NCT06700863: Screening of Biomarkers and Related Mechanisms for RIX
Official title: Screening of Diagnostic Biomarkers and Related Mechanisms for Radiation-induced Xerostomia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Xerostomia Due to Radiotherapy (Disorder)
Keywords: Head and neck tumor
radiotherapy
biomarkers
xerostomia
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Jinling Hospital, China
name: Jiangsu Cancer Institute & Hospital
First posted: 2024-11-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Head and neck cancer radiotherapy patients

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.

Primary outcomes:
measure: Resting saliva flow measurement
timeFrame: From the start of radiotherapy to 3 months after completion
Secondary outcomes:
measure: Changes in Quality of Life and xerostomia Questionnaire Scores
timeFrame: From the start of radiotherapy to 3 months after completion
measure: Comparison of Body Mass Index
timeFrame: From the start of radiotherapy to 3 months after completion
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Affiliated Jinling Hospital, Medical School of Nanjing University
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
References: