A Lithium-containing Mouthwash Prevention and Treatment of Oral Mucositis and Dysgeusia in Patients Undergoing Radiotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

175 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2025-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Lactobacillus Reuteri Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors

NCT06285591

Head and Neck Malignant Tumors

COMPLETED PHASE2

Copaíba-based Mouthwash in Oral Mucotitis Prevention and Treatment in Oral Cancer Patients During Radioteraphy

NCT06708702

Oral Mucositis Oral Mucositis (Ulcerative) Due to Radiation Oral Mucositis (Ulcerative) Due to Antineoplastic Therapy +1 more

RECRUITING PHASE2

L-lysine in Treating Oral Mucositis in Patients Undergoing Radiation Therapy With or Without Chemotherapy For Head and Neck Cancer

NCT01155609

Mucositis Oral Complications of Chemotherapy Oral Complications of Radiation Therapy +65 more

COMPLETED NA

A Mouthwash Medicine for the Reduction or Prevention of Mouth Ulceration Caused by Radiotherapy for Head and Neck Cancer

NCT06669390

Oral Mucositis

COMPLETED PHASE1

Sodium Bicarbonate for Reducing Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma.

NCT06854510

Nasopharyngeal Cancinoma (NPC)

RECRUITING PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head and Neck Squamous Cell Carcinoma Malignant Head and Neck Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

0.03 mol/L lithium mouthwash

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.

Group Type EXPERIMENTAL

No interventions assigned to this group

0.06 mol/L lithium mouthwash

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.

Group Type EXPERIMENTAL

No interventions assigned to this group

0.10 mol/L lithium mouthwash

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.

Group Type EXPERIMENTAL

No interventions assigned to this group

0.15 mol/L lithium mouthwash

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.

Group Type EXPERIMENTAL

No interventions assigned to this group

0.30 mol/L lithium mouthwash

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.

Group Type EXPERIMENTAL

lithium-containing mouthwash

Intervention Type 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.

Lithium mouthwash

Effective lithium salt concentrations screened in the Phase I trial is used as active interventions in this group of interventions.

Group Type ACTIVE_COMPARATOR

lithium-containing mouthwash

Intervention Type 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.

Placebo mouthwash

Placebo Mouthwash is mainly composed of citric acid and sodium hydroxide, transparent colorless liquid.

Group Type PLACEBO_COMPARATOR

Plcacebo mouthwash

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

lithium-containing mouthwash

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.

Intervention Type DRUG

Plcacebo mouthwash

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.

Intervention Type DRUG

lithium-containing mouthwash

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No