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

NCT06854510 | Recruiting Phase 2

• 1 other identifier: B2025-016-01
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nasopharyngeal Cancinoma (NPC)

Outcome Measures

Primary Outcomes (1)

• The incidence of grade ≥2 oral mucositis

  Oral mucositis grade was evaluated using RTOG (Radiation Therapy Oncology Group) criteria, with intergroup differences analyzed by Chi-square test.

  from radiotherapy commencement until 14 days post-radiotherapy

Secondary Outcomes (4)

• The incidence of grade ≥3 oral mucositis

  from radiotherapy commencement until 14 days post-radiotherapy

• The incidence of grade ≥1 oral mucositis

  from radiotherapy commencement until 14 days post-radiotherapy

• Oral fungal detection rate

  from radiotherapy commencement until 14 days post-radiotherapy

• Rate of oral pH decline

  from radiotherapy commencement until 14 days post-radiotherapy

Study Arms (2)

Sodium Bicarbonate Solution Gargle Group

EXPERIMENTAL

Oral rinses using 2.5% sodium bicarbonate solution were administered daily throughout the radiotherapy course

Drug: Gargle with 2.5% sodium bicarbonate solution during radiotherapy

Sodium Chloride Solution Gargle Group

PLACEBO COMPARATOR

Oral rinses using 0.9% sodium chloride solution were administered daily throughout the radiotherapy course

Drug: Gargle with 0.9% sodium chloride solution during radiotherapy

Interventions

Gargle with 2.5% sodium bicarbonate solution during radiotherapy DRUG

In addition to routine oral care, patients received sodium bicarbonate solution gargle therapy from the initiation of radiotherapy until its completion. The treatment protocol is as follows: For patients with oral mucositis of grade 0 - 1, gargle with a 2.5% sodium bicarbonate solution (for 1 - 2 minutes each time) three times a day and spit out the liquid after each gargle. For patients with oral mucositis of grade ≥ 2, gargle with a 2.5% sodium bicarbonate solution (for 1 - 2 minutes each time) four to five times a day and spit out the liquid after each gargle.

Sodium Bicarbonate Solution Gargle Group

Gargle with 0.9% sodium chloride solution during radiotherapy DRUG

In addition to routine oral care, patients received 0.9% sodium chloride solution gargle therapy from the initiation of radiotherapy until its completion. The treatment protocol is as follows: For patients with oral mucositis of grade 0 - 1, gargle with a 0.9% sodium chloride solution (for 1 - 2 minutes each time) three times a day and spit out the liquid after each gargle. For patients with oral mucositis of grade ≥ 2, gargle with a 0.9% sodium chloride solution (for 1 - 2 minutes each time) four to five times a day and spit out the liquid after each gargle.

Sodium Chloride Solution Gargle Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients receiving non-platinum-based concurrent chemotherapy regimens.
• Radiation fields encompassing level Ib lymph nodes.
• History of pre-existing oral mucosal disorders or recurrent oral ulceration.
• Prior radiotherapy history.
• Severe coexisting illness.
• Pregnancy or lactation.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510060, China

RECRUITING

MeSH Terms

Interventions

Mouthwashes

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

Ling-Long Tang

CONTACT

02087343840; tangll@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: February 20, 2025
• First Posted: March 3, 2025
• Study Start: February 21, 2025
• Primary Completion: January 1, 2026
• Study Completion (Estimated): February 1, 2030
• Last Updated: March 3, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)