RecruitingPhase 2Phase 3NCT06854510

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

A Prospective, Single-Center, Randomized Controlled Study on Sodium Bicarbonate Mouthwash for the Prevention and Treatment of Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma.

Sponsor

Sun Yat-sen University

Enrollment

196 participants

Start Date

Feb 21, 2025

Study Type

INTERVENTIONAL

Conditions

Nasopharyngeal Cancinoma (NPC)

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

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria6

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.

Exclusion Criteria6

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.

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Interventions

DRUGGargle with 2.5% sodium bicarbonate solution during radiotherapy

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.

DRUGGargle with 0.9% sodium chloride solution during radiotherapy

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.