Head and Neck Squamous Cell CarcinomaPhase 1/2NCT06251050
A Lithium-containing Mouthwash Prevention and Treatment of Oral Mucositis and Dysgeusia in Patients Undergoing Radiotherapy
A Phase 1/2 study testing lithium-containing mouthwash （Phase I）, Plcacebo mouthwash （Phase II） and lithium-containing mouthwash（Phase II） in people with Head and Neck Squamous Cell Carcinoma and Malignant Head and Neck Tumors, run by West China Hospital at 1 site in China.
Trial summary
To evaluate the efficacy and safety of lithium-containing mouthwash for prevention and treatment of oral mucositis and dysgeusia in patients undergoing radiotherapy for malignant head and neck tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Malignant Head and Neck Tumors
- What is being tested?
- lithium-containing mouthwash （Phase I）, Plcacebo mouthwash （Phase II） and lithium-containing mouthwash（Phase II）
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2024to 1 May 2025
- Phase
- Phase 1/2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients pathologically diagnosed with non-metastatic head and neck malignant tumors; Aged 18-80 years; Eastern Cooperative Oncology Group performance status of ≤2; Planning to receive definitive RT or postoperative adjuvant RT; Normal liver, kidney and bone marrow function; Sign informed consent.
Who cannot join
- Known to be allergic to lithium or other components of mouthwash or severe allergic constitution; Poor oral hygiene and/or severe periodontal diseases; Any previous RT to the head and neck region, Severe kidney disease, severe cardiovascular disease, myasthenia gravis, Parkinson's disease or epilepsy; Recent use or current use of diuretics or other drugs known to interact with lithium; Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the efficacy and safety of lithium-containing mouthwash for prevention and treatment of oral mucositis and dysgeusia in patients undergoing radiotherapy for malignant head and neck tumors.
Read the detailed description
The goal of this clinical trial is to evaluate the efficacy and safety of lithium-containing mouthwash in reducing the incidence, duration, and severity of severe oral mucositis (SOM) , and the incidence of dysgeusia. The main questions it aims to answer are whether lithium-containing mouthwash can effectively prevent and treat radiation-induced oral mucositis and dysgeusia, and whether it will cause adverse events in patients undergoing radiotherapy.
Participants will be instructed to use lithium-containing mouthwash or placebo mouthwash three times daily from the beginning to the end of RT.
Researchers will compare lithium-containing mouthwash group and placebo group to see if lithium-containing mouthwash are beneficial in preventing and treating oral mucositis and dysgeusia in patients undergoing radiotherapy.
- Being tested
- lithium-containing mouthwash （Phase I）, Plcacebo mouthwash （Phase II）, lithium-containing mouthwash（Phase II）
- Keywords
- head and neck squamous cell carcinoma, nasopharyngeal carcinoma, Malignant Head and Neck tumors, oral mucositis, lithium-containing mouthwash
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Nasopharyngeal Carcinoma, Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lithium-containing mouthwash （Phase I）Drug
The main ingredients of lithium-containing mouthwash are lithium carbonate and citric acid. A total of 5 concentration gradients of lithium-containing mouthwash are set, including 0.03, 0.06, 0.10, 0.15 and 0.30 mol/L. Mouthwash is used to gargle and left in the mouth for 5 min to be spat out three times a day from the first day of radiotherapy up to the end of treatment.
Plcacebo mouthwash （Phase II）Drug
Placebo Mouthwash is mainly composed of citric acid and sodium hydroxide, transparent colorless liquid. Mouthwash is used to gargle and left in the mouth for 5 min to be spat out three times a day from the first day of radiotherapy up to the end of treatment.
lithium-containing mouthwash（Phase II）Drug
Effective lithium salt concentrations screened in the Phase I trial is used as active interventions in this group of interventions. Mouthwash is used to gargle and left in the mouth for 5 min to be spat out three times a day from the first day of radiotherapy up to the end of treatment.
| Study group | Role | What they receive |
|---|---|---|
| lithium-containing mouthwash （Phase I ） | Experimental | Phase I consists of 5 cohorts of 3-6 patients each, with all patients enrolled sequentially. Patients receive 0.03, 0.06, 0.10, 0.15, and 0.30 mol/L of lithium-containing mouthwash, respectively. In this phase, patients are instructed to use 10 mL of lithium mouthwash to gargle and retain it in the mouth for 5 minutes before spitting it out, from the first day of radiotherapy until the end of treatment. Receives: Drug: lithium-containing mouthwash （Phase I） |
| lithium-containing mouthwash （Phase II ） | Experimental | Phase II is a randomized, placebo-controlled trial. All patients are randomly assigned to the experimental group or the placebo group. The lithium concentration in the mouthwash used in the experimental group is the effective concentration identified in Phase I, whereas the placebo group receives a mouthwash formulation without lithium salts. From the first day of radiotherapy until the end of treatment, patients use 10 mL of lithium mouthwash or placebo mouthwash to gargle and retain it in the mouth for 5 minutes before spitting it out. Receives: Drug: Plcacebo mouthwash （Phase II）; Drug: lithium-containing mouthwash（Phase II） |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of Severe Oral mucositis (WHO grade ≥3)
Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale.
Measured: From the start of radiotherapy to 8 weeks after completion of radiotherapy
Secondary outcomes (7)
Xerostomia
Patients self-rated xerostomia according to summated xerostomia inventory (SXI), and researchers measured saliva flow rates.
Measured: 1 week before radiotherapy ; at the middle of radiotherapy (3 weeks after the start of radiotherapy) ; at the end of radiotherapy (the last radiation dose received, usually 6 or 6.5 weeks); and 1, 3, 6, 9 and 12 months after the end of radiotherapy
Patients' quality of life assessment of EORTC QLQ-C30 and H&N35 questionnaires.
EORTC QLQ-C30 and H\&N35 questionnaires
Measured: 1 week before radiotherapy; at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks); ; and 1, 3, 6, 9 and 12 months after the end of radiotherapy
Adverse events
Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version
Measured: From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks
Mouth and throat soreness (MTS) scores
Patients report mouth and throat soreness (MTS) scores (Likert scale 1 to 5) via the oral mucositis weekly questionnaire （OMWQ）. Higher score indicates more severe symptoms.
Measured: The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6 1/2 weeks
The duration of Severe Oral mucositis (WHO grade ≥3)
The first determination of SOM to the first instance of non-severe OM (WHO grade <3), without a subsequent instance of SOM. Patients without observed SOM were assigned a duration of 0 days.
Measured: From the start of radiotherapy to 8 weeks after completion of radiotherapy
The time to onset of Severe Oral mucositis (WHO grade ≥3)
Time from the first day of radiotherapy to the first determination of SOM. Patients without observed SOM were assigned onset days of 6 or 6.5 weeks.
Measured: From the start of radiotherapy to 8 weeks after completion of radiotherapy
Taste function
Patients self-rated dysgeusia, Electrogustometer test and taste strips test.
Measured: 1 week before radiotherapy ; at the middle of radiotherapy (3 weeks after the start of radiotherapy) ; at the end of radiotherapy (the last radiation dose received, usually 6 or 6.5 weeks); and 1, 3, 6, 9 and 12 months after the end of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by West China HospitalThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase 1 containes 5 arms including 0.03, 0.06, 0.10, 0.15 and 0.30 mol/L lithium mouthwash. Phase 2 containes 2 arms including lithium mouthwash group and palcebo group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xingchen Peng, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251050
- Sponsor's protocol ID
- 2023-863
- Status last verified
- Aug 2026
- First submitted
- 1 Feb 2024
- Last updated
- 13 Aug 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 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Lithium-containing Mouthwash Prevention and Treatment of Oral Mucositis and Dysgeusia in Patients Undergoing Radiotherapy
- ClinicalTrials.gov ID
- NCT06251050
- Acronym / sponsor ID
- 2023-863
- Keywords
- head and neck squamous cell carcinoma, nasopharyngeal carcinoma, Malignant Head and Neck tumors, oral mucositis, lithium-containing mouthwash
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 9 Feb 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.
To evaluate the efficacy and safety of lithium-containing mouthwash for prevention and treatment of oral mucositis and dysgeusia in patients undergoing radiotherapy for malignant head and neck tumors.
Detailed description
The goal of this clinical trial is to evaluate the efficacy and safety of lithium-containing mouthwash in reducing the incidence, duration, and severity of severe oral mucositis (SOM) , and the incidence of dysgeusia. The main questions it aims to answer are whether lithium-containing mouthwash can effectively prevent and treat radiation-induced oral mucositis and dysgeusia, and whether it will cause adverse events in patients undergoing radiotherapy.
Participants will be instructed to use lithium-containing mouthwash or placebo mouthwash three times daily from the beginning to the end of RT.
Researchers will compare lithium-containing mouthwash group and placebo group to see if lithium-containing mouthwash are beneficial in preventing and treating oral mucositis and dysgeusia in patients undergoing radiotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Phase 1 containes 5 arms including 0.03, 0.06, 0.10, 0.15 and 0.30 mol/L lithium mouthwash. Phase 2 containes 2 arms including lithium mouthwash group and palcebo group.
| Arm | Type | Receives |
|---|---|---|
| lithium-containing mouthwash （Phase I ） | Experimental | Drug: lithium-containing mouthwash （Phase I）Phase I consists of 5 cohorts of 3-6 patients each, with all patients enrolled sequentially. Patients receive 0.03, 0.06, 0.10, 0.15, and 0.30 mol/L of lithium-containing mouthwash, respectively. In this phase, patients are instructed to use 10 mL of lithium mouthwash to gargle and retain it in the mouth for 5 minutes before spitting it out, from the first day of radiotherapy until the end of treatment. |
| lithium-containing mouthwash （Phase II ） | Experimental | Drug: Plcacebo mouthwash （Phase II）, Drug: lithium-containing mouthwash（Phase II）Phase II is a randomized, placebo-controlled trial. All patients are randomly assigned to the experimental group or the placebo group. The lithium concentration in the mouthwash used in the experimental group is the effective concentration identified in Phase I, whereas the placebo group receives a mouthwash formulation without lithium salts. From the first day of radiotherapy until the end of treatment, patients use 10 mL of lithium mouthwash or placebo mouthwash to gargle and retain it in the mouth for 5 minutes before spitting it out. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients pathologically diagnosed with non-metastatic head and neck malignant tumors; Aged 18-80 years; Eastern Cooperative Oncology Group performance status of ≤2; Planning to receive definitive RT or postoperative adjuvant RT; Normal liver, kidney and bone marrow function; Sign informed consent.
Key exclusion criteria (1 listed)
- Known to be allergic to lithium or other components of mouthwash or severe allergic constitution; Poor oral hygiene and/or severe periodontal diseases; Any previous RT to the head and neck region, Severe kidney disease, severe cardiovascular disease, myasthenia gravis, Parkinson's disease or epilepsy; Recent use or current use of diuretics or other drugs known to interact with lithium; Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).
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 |
|---|---|---|
| lithium-containing mouthwash （Phase I）The main ingredients of lithium-containing mouthwash are lithium carbonate and citric acid. A total of 5 concentration gradients of lithium-containing mouthwash are set, including 0.03, 0.06, 0.10, 0.15 and 0.30 mol/L. Mouthwash is used to gargle and left in the mouth for 5 min to be spat out three times a day from the first day of radiotherapy up to the end of treatment. | Drug | lithium-containing mouthwash （Phase I ） |
| Plcacebo mouthwash （Phase II）Placebo Mouthwash is mainly composed of citric acid and sodium hydroxide, transparent colorless liquid. Mouthwash is used to gargle and left in the mouth for 5 min to be spat out three times a day from the first day of radiotherapy up to the end of treatment. | Drug | lithium-containing mouthwash （Phase II ） |
| lithium-containing mouthwash（Phase II）Effective lithium salt concentrations screened in the Phase I trial is used as active interventions in this group of interventions. Mouthwash is used to gargle and left in the mouth for 5 min to be spat out three times a day from the first day of radiotherapy up to the end of treatment. | Drug | lithium-containing mouthwash （Phase II ） |
Primary outcome
The incidence of Severe Oral mucositis (WHO grade ≥3)
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy
Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale.
7 secondary outcomes
Xerostomia
Time frame: 1 week before radiotherapy ; at the middle of radiotherapy (3 weeks after the start of radiotherapy) ; at the end of radiotherapy (the last radiation dose received, usually 6 or 6.5 weeks); and 1, 3, 6, 9 and 12 months after the end of radiotherapy
Patients' quality of life assessment of EORTC QLQ-C30 and H&N35 questionnaires.
Time frame: 1 week before radiotherapy; at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks); ; and 1, 3, 6, 9 and 12 months after the end of radiotherapy
Adverse events
Time frame: From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks
Mouth and throat soreness (MTS) scores
Time frame: The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6 1/2 weeks
The duration of Severe Oral mucositis (WHO grade ≥3)
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy
The time to onset of Severe Oral mucositis (WHO grade ≥3)
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy
Taste function
Time frame: 1 week before radiotherapy ; at the middle of radiotherapy (3 weeks after the start of radiotherapy) ; at the end of radiotherapy (the last radiation dose received, usually 6 or 6.5 weeks); and 1, 3, 6, 9 and 12 months after the end of radiotherapy
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 13 Aug 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing lithium-containing mouthwash （Phase I）, Plcacebo mouthwash （Phase II） and lithium-containing mouthwash（Phase II） in people with Head and Neck Squamous Cell Carcinoma and Malignant Head and Neck Tumors, run by West China Hospital at 1 site 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 1 inclusion and 1 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 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The incidence of Severe Oral mucositis (WHO grade ≥3) (time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy). 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 13 Aug 2026.