A Lithium-containing Mouthwash Prevention and Treatment of Oral Mucositis and Dysgeusia in Patien… (NCT06251050) | Clinical Trial Compass
CompletedPhase 1/2
A Lithium-containing Mouthwash Prevention and Treatment of Oral Mucositis and Dysgeusia in Patients Undergoing Radiotherapy
China175 participantsStarted 2024-03-01
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria:
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.
Exclusion Criteria:
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).
What they're measuring
1
The incidence of Severe Oral mucositis (WHO grade ≥3)
Timeframe: From the start of radiotherapy to 8 weeks after completion of radiotherapy