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

NCT06251050 | Completed Phase 1

• 1 other identifier: 2023-863
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  From the start of radiotherapy to 8 weeks after completion of radiotherapy

Secondary Outcomes (7)

• Xerostomia

  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.

  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

  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

  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)

  From the start of radiotherapy to 8 weeks after completion of radiotherapy

Study Arms (7)

0.03 mol/L lithium mouthwash

EXPERIMENTAL

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.

0.06 mol/L lithium mouthwash

EXPERIMENTAL

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.

0.10 mol/L lithium mouthwash

EXPERIMENTAL

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.

0.15 mol/L lithium mouthwash

EXPERIMENTAL

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.

0.30 mol/L lithium mouthwash

EXPERIMENTAL

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.

Drug: lithium-containing mouthwash

Lithium mouthwash

ACTIVE COMPARATOR

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

Drug: lithium-containing mouthwash

Placebo mouthwash

PLACEBO COMPARATOR

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

Drug: Plcacebo mouthwash

Interventions

lithium-containing mouthwash 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.

0.30 mol/L lithium mouthwash

Plcacebo mouthwash 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.

Placebo mouthwash

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Head and Neck Neoplasms; Nasopharyngeal Carcinoma; Stomatitis

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Mouth Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Model Details: 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.

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: February 9, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2025
• Study Completion: May 1, 2025
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)