Ignite Creation Date:
2025-12-24 @ 5:23 PM
Ignite Modification Date:
2025-12-28 @ 7:21 PM
Study NCT ID:
NCT06251050
Status:
COMPLETED
Last Update Posted:
2025-05-30
First Post:
2024-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Lithium-containing Mouthwash Prevention and Treatment of Oral Mucositis and Dysgeusia in Patients Undergoing Radiotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}, {'id': 'D013280', 'term': 'Stomatitis'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009059', 'term': 'Mouth Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Phase 1 containes 5 arms including 0.03, 0.06, 0.10, 0.15 and 0.30 mol/L lithium mouthwash.\n\nPhase 2 containes 2 arms including lithium mouthwash group and palcebo group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 175}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2024-02-01', 'studyFirstSubmitQcDate': '2024-02-01', 'lastUpdatePostDateStruct': {'date': '2025-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of Severe Oral mucositis (WHO grade ≥3)', 'timeFrame': 'From the start of radiotherapy to 8 weeks after completion of radiotherapy', 'description': 'Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale.'}], 'secondaryOutcomes': [{'measure': 'Xerostomia', 'timeFrame': '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', 'description': 'Patients self-rated xerostomia according to summated xerostomia inventory (SXI), and researchers measured saliva flow rates.'}, {'measure': "Patients' quality of life assessment of EORTC QLQ-C30 and H&N35 questionnaires.", 'timeFrame': '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', 'description': 'EORTC QLQ-C30 and H\\&N35 questionnaires'}, {'measure': 'Adverse events', 'timeFrame': 'From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks', 'description': 'Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version'}, {'measure': 'Mouth and throat soreness (MTS) scores', 'timeFrame': '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', 'description': '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.'}, {'measure': 'The duration of Severe Oral mucositis (WHO grade ≥3)', 'timeFrame': 'From the start of radiotherapy to 8 weeks after completion of radiotherapy', 'description': '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.'}, {'measure': 'The time to onset of Severe Oral mucositis (WHO grade ≥3)', 'timeFrame': 'From the start of radiotherapy to 8 weeks after completion of radiotherapy', 'description': '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.'}, {'measure': 'Taste function', 'timeFrame': '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', 'description': 'Patients self-rated dysgeusia, Electrogustometer test and taste strips test.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['head and neck squamous cell carcinoma', 'nasopharyngeal carcinoma', 'Malignant Head and Neck tumors', 'oral mucositis', 'lithium-containing mouthwash'], 'conditions': ['Head and Neck Squamous Cell Carcinoma', 'Malignant Head and Neck Tumors']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nParticipants will be instructed to use lithium-containing mouthwash or placebo mouthwash three times daily from the beginning to the end of RT.\n\nResearchers 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients 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.\n\nExclusion Criteria:\n\nKnown 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)."}, 'identificationModule': {'nctId': 'NCT06251050', 'briefTitle': 'A Lithium-containing Mouthwash Prevention and Treatment of Oral Mucositis and Dysgeusia in Patients Undergoing Radiotherapy', 'organization': {'class': 'OTHER', 'fullName': 'West China Hospital'}, 'officialTitle': 'A Lithium-containing Mouthwash Prevention and Treatment of Oral Mucositis and Dysgeusia in Patients Undergoing Radiotherapy', 'orgStudyIdInfo': {'id': '2023-863'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '0.03 mol/L lithium mouthwash', 'description': 'The main ingredients of mouthwash are lithium carbonate and citric acid, transparent colorless liquid. In this group, 10 ml of 0.03 mol/L lithium mouthwash is used to gargle and left in the mouth for 5 min to be spat out from the first day of radiotherapy up to the end of treatment.'}, {'type': 'EXPERIMENTAL', 'label': '0.06 mol/L lithium mouthwash', 'description': 'The main ingredients of mouthwash are lithium carbonate and citric acid, transparent colorless liquid.. In this group, 10 ml of 0.06 mol/L lithium mouthwash is used to gargle and left in the mouth for 5 min to be spat out from the first day of radiotherapy up to the end of treatment.'}, {'type': 'EXPERIMENTAL', 'label': '0.10 mol/L lithium mouthwash', 'description': 'The main ingredients of mouthwash are lithium carbonate and citric acid,transparent colorless liquid. In this group, 10 ml of 0.10 mol/L lithium mouthwash is used to gargle and left in the mouth for 5 min to be spat out from the first day of radiotherapy up to the end of treatment.'}, {'type': 'EXPERIMENTAL', 'label': '0.15 mol/L lithium mouthwash', 'description': 'The main ingredients of mouthwash are lithium carbonate and citric acid, transparent colorless liquid. In this group, 10 ml of 0.15 mol/L lithium mouthwash is used to gargle and left in the mouth for 5 min to be spat out from the first day of radiotherapy up to the end of treatment.'}, {'type': 'EXPERIMENTAL', 'label': '0.30 mol/L lithium mouthwash', 'description': 'The main ingredients of mouthwash are lithium carbonate and citric acid, transparent colorless liquid. In this group, 10 ml of 0.30 mol/L lithium mouthwash is used to gargle and left in the mouth for 5 min to be spat out from the first day of radiotherapy up to the end of treatment.', 'interventionNames': ['Drug: lithium-containing mouthwash']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lithium mouthwash', 'description': 'Effective lithium salt concentrations screened in the Phase I trial is used as active interventions in this group of interventions.', 'interventionNames': ['Drug: lithium-containing mouthwash']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo mouthwash', 'description': 'Placebo Mouthwash is mainly composed of citric acid and sodium hydroxide, transparent colorless liquid.', 'interventionNames': ['Drug: Plcacebo mouthwash']}], 'interventions': [{'name': 'lithium-containing mouthwash', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['0.30 mol/L lithium mouthwash']}, {'name': 'Plcacebo mouthwash', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Placebo mouthwash']}, {'name': 'lithium-containing mouthwash', 'type': 'DRUG', 'description': '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.', 'armGroupLabels': ['Lithium mouthwash']}]}, 'contactsLocationsModule': {'locations': [{'zip': '610041', 'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West China Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Xingchen Peng', 'investigatorAffiliation': 'West China Hospital'}}}}