Clinical trial NCT06251050: A Lithium-containing Mouthwash Prevention and Treatment of Oral Mucositis and Dysgeusia in Patients Undergoing Radiotherapy
Official title: A Lithium-containing Mouthwash Prevention and Treatment of Oral Mucositis and Dysgeusia in Patients Undergoing Radiotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Head and Neck Squamous Cell Carcinoma
Malignant Head and Neck Tumors
Keywords: head and neck squamous cell carcinoma
nasopharyngeal carcinoma
Malignant Head and Neck tumors
oral mucositis
lithium-containing mouthwash
Lead sponsor: West China Hospital
Sponsor class: OTHER
First posted: 2024-02-09
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: The incidence of Severe Oral mucositis (WHO grade ≥3)
timeFrame: From the start of radiotherapy to 8 weeks after completion of radiotherapy
Secondary outcomes:
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
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
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
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
measure: The duration of Severe Oral mucositis (WHO grade ≥3)
timeFrame: From the start of radiotherapy to 8 weeks after completion of radiotherapy
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
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
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital, Sichuan University
state: Sichuan
Study officials:
References: