Screening of Biomarkers and Related Mechanisms for RIX (RIX)

September 1, 2026 updated by: The First Affiliated Hospital with Nanjing Medical University

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: mingzhe m xin
  • Phone Number: 86+15249691991

Study Locations

  • China
      • Hangzhou, China
        • The Second Affiliated Hospital, Zhejiang University School of Medicine
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Cancer Hospital
      • Nanjing, Jiangsu, China
        • The First Affiliated Hospital of Nanjing Medical University
      • Nanjing, Jiangsu, China, 450041
        • Affiliated Jinling Hospital, Medical School of Nanjing University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Resting saliva flow measurement
Time Frame: From the start of radiotherapy to 3 months after completion
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Quality of Life and xerostomia Questionnaire Scores
Time Frame: From the start of radiotherapy to 3 months after completion
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
Time Frame: From the start of radiotherapy to 3 months after completion
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The First Affiliated Hospital with Nanjing Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Jiangsu Cancer Institute & Hospital
Jinling Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 17, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 19, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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