Xerostomia Due to Radiotherapy (Disorder)RIXNCT06700863
Screening of Biomarkers and Related Mechanisms for RIX
An observational study of Xerostomia Due to Radiotherapy (Disorder), run by The First Affiliated Hospital with Nanjing Medical University at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Xerostomia Due to Radiotherapy (Disorder)
- What is being tested?
- Radiation Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 4 sitesChina
- Study dates
- 17 May 2024to 31 Aug 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Head and neck cancer radiotherapy patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
China4 sites
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou
Affiliated Jinling Hospital, Medical School of Nanjing University
Nanjing, Jiangsu, 450041
Jiangsu Cancer Hospital
Nanjing, Jiangsu
The First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu
About this study
Official title: 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.
- Being tested
- Radiation Therapy
- Keywords
- Head and neck tumor, radiotherapy, biomarkers, xerostomia
- Medical subject headings
- Head and Neck Neoplasms, Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
Radiotherapy for Head and Neck Cancer Patients
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Radiation: Radiation Therapy | |
| Moderate to severe xerostomia during radiotherapy | A resting saliva flow rate below 0.5ml/10min during radiotherapy is considered moderate to severe xerostomia Receives: Radiation: Radiation Therapy | |
| Mild xerostomia after radiotherapy | After radiotherapy, a resting saliva flow rate between 0.5ml/10min-1ml/10min is considered mild dry mouth Receives: Radiation: Radiation Therapy | |
| Moderate to severe xerostomia xerostomia after radiotherapy | A resting saliva flow rate below 0.5ml/10min after radiotherapy is considered moderate to severe xerostomia Receives: Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the start of radiotherapy to 3 months after completion
Secondary outcomes (2)
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.
Measured: 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.
Measured: From the start of radiotherapy to 3 months after completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start17 May 2024
- Primary completion1 Jul 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Xerostomia Due to Radiotherapy (Disorder)Studies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jinling Hospital, China, Jiangsu Cancer Institute & Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06700863
- Sponsor's protocol ID
- 2024-SR-545
- Acronym
- RIX
- Status last verified
- Nov 2024
- First submitted
- 19 Sep 2024
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening of Diagnostic Biomarkers and Related Mechanisms for Radiation-induced Xerostomia
- ClinicalTrials.gov ID
- NCT06700863
- Acronym / sponsor ID
- RIX / 2024-SR-545
- Keywords
- Head and neck tumor, radiotherapy, biomarkers, xerostomia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Jinling Hospital, China, Jiangsu Cancer Institute & Hospital
- Study start
- 17 May 2024 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 22 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| No xerostomia before radiotherapy | – | –Resting saliva flow rate greater than 1ml/10min before radiotherapy |
| Mild xerostomia during radiotherapy | – | Radiation: Radiation TherapyDuring radiotherapy, a resting saliva flow rate between 0.5ml/10min-1ml/10min is considered mild dry mouth |
| Moderate to severe xerostomia during radiotherapy | – | Radiation: Radiation TherapyA resting saliva flow rate below 0.5ml/10min during radiotherapy is considered moderate to severe xerostomia |
| Mild xerostomia after radiotherapy | – | Radiation: Radiation TherapyAfter radiotherapy, a resting saliva flow rate between 0.5ml/10min-1ml/10min is considered mild dry mouth |
| Moderate to severe xerostomia xerostomia after radiotherapy | – | Radiation: Radiation TherapyA resting saliva flow rate below 0.5ml/10min after radiotherapy is considered moderate to severe xerostomia |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Head and neck cancer radiotherapy patients
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation TherapyRadiotherapy for Head and Neck Cancer Patients | Radiation | Mild xerostomia after radiotherapy, Mild xerostomia during radiotherapy, Moderate to severe xerostomia during radiotherapy, Moderate to severe xerostomia xerostomia after radiotherapy |
Primary outcome
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.
2 secondary outcomes
Changes in Quality of Life and xerostomia Questionnaire Scores
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Xerostomia Due to Radiotherapy (Disorder)
Not yet recruiting
Oral Care Program for Mouth Side Effects During Head and Neck Radiation Therapy
Head and Neck Cancer (H&N), Oral Mucositis (Ulcerative) Due to Radiation
RecruitingObservational study
Screening of Biomarkers and Related Mechanisms for RIX
Xerostomia Due to Radiotherapy (Disorder)
Not yet recruitingPhase 2
Repeated Mesenchymal Stem Cell Therapy for Radiation-Induced Hyposalivation and Xerostomia in Head and Neck Cancer Survivors
Xerostomia Due to Hyposecretion of Salivary Gland, Xerostomia Due to Radiotherapy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Xerostomia Due to Radiotherapy (Disorder), run by The First Affiliated Hospital with Nanjing Medical University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resting saliva flow measurement (time frame: From the start of radiotherapy to 3 months after completion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.