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NCT Number: NCT06700863

Screening of Biomarkers and Related Mechanisms for RIX

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Affiliated Jinling Hospital, Medical School of Nanjing University, Nanjing, Jiangsu, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

radiation therapy

Radiation

Radiotherapy for Head and Neck Cancer Patients

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Jin

CONTACT

[email protected]

86+18951013666

mingzhe m xin

CONTACT

86+15249691991

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital with Nanjing Medical University

Other

Collaborators

  • Jiangsu Cancer Institute & Hospital
  • Jinling Hospital, China

Registry information

Official study title

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

Acronym: RIX

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 22, 2024
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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