A Prospective, Single-Center, Randomized Controlled Study on Sodium Bicarbonate Mouthwash for the Prevention and Treatment of Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY
To evaluate whether the use of 2.5% sodium bicarbonate mouthwash throughout the entire course of radiotherapy for nasopharyngeal carcinoma reduces the severity of radiation-induced oral mucositis and improves patient adherence to treatment.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Histopathologically confirmed nasopharyngeal carcinoma.
• No evidence of distant metastasis (M0).
• Scheduled to receive radical radiotherapy.
• Karnofsky scale (KPS) \> 70.
• Age 18-70 years.
• Capacity for independent oral rinse administration without dysphagia.
Locations
Other Locations
China
Sun Yat-sen University Cancer Center
RECRUITING
Guangzhou
Contact Information
Primary
Ling-Long Tang
tangll@sysucc.org.cn
02087343840
Time Frame
Start Date: 2025-02-21
Estimated Completion Date: 2030-02
Participants
Target number of participants: 196
Treatments
Experimental: Sodium Bicarbonate Solution Gargle Group
Oral rinses using 2.5% sodium bicarbonate solution were administered daily throughout the radiotherapy course
Placebo_comparator: Sodium Chloride Solution Gargle Group
Oral rinses using 0.9% sodium chloride solution were administered daily throughout the radiotherapy course
Related Therapeutic Areas
Sponsors
Leads: Sun Yat-sen University