Screening of Biomarkers and Related Mechanisms for RIX (RIX)

Screening of Diagnostic Biomarkers and Related Mechanisms for Radiation-induced Xerostomia

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.

Study Overview

• Status: Recruiting
• Conditions: Xerostomia Due to Radiotherapy (Disorder)
• Intervention / Treatment: Radiation: Radiation Therapy

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Lei Jin; Phone Number: 86+18951013666; Email: ljin@nju.edu.cn
• Study Contact Backup: Name: mingzhe m xin; Phone Number: 86+15249691991

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Recruiting
      • Jiangsu Cancer Hospital
      • Contact: lirong Wu; Phone Number: 86+13701588737; Email: wulirong126@126.com
    • Nanjing, Jiangsu, China
      • Not yet recruiting
      • The First Affiliated Hospital of Nanjing Medical University
      • Contact: Lei Jin; Phone Number: 86+18951013666; Email: ljin@nju.edu.cn
    • Nanjing, Jiangsu, China, 450041
      • Not yet recruiting
      • Affiliated Jinling Hospital, Medical School of Nanjing University
      • Contact: yi Shuai; Phone Number: 86+18251920440; Email: handsy@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Head and neck cancer radiotherapy patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

5

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
No xerostomia before radiotherapy; Resting saliva flow rate greater than 1ml/10min before radiotherapy
Mild xerostomia during radiotherapy; During radiotherapy, a resting saliva flow rate between 0.5ml/10min-1ml/10min is considered mild dry mouth	Radiation: Radiation Therapy; Radiotherapy for Head and Neck Cancer Patients
Moderate to severe xerostomia during radiotherapy; A resting saliva flow rate below 0.5ml/10min during radiotherapy is considered moderate to severe xerostomia	Radiation: Radiation Therapy; Radiotherapy for Head and Neck Cancer Patients
Mild xerostomia after radiotherapy; After radiotherapy, a resting saliva flow rate between 0.5ml/10min-1ml/10min is considered mild dry mouth	Radiation: Radiation Therapy; Radiotherapy for Head and Neck Cancer Patients
Moderate to severe xerostomia xerostomia after radiotherapy; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From the start of radiotherapy to 3 months after completion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	From the start of radiotherapy to 3 months after completion

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital with Nanjing Medical University
• Collaborators: Jiangsu Cancer Institute & Hospital; Jinling Hospital, China

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 19, 2024
• First Submitted That Met QC Criteria: November 20, 2024
• First Posted (Estimated): November 22, 2024

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 20, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: biomarkers; radiotherapy; xerostomia; Head and neck tumor
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Xerostomia
• Other Study ID Numbers: 2024-SR-545

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No