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

Sun Yat-sen University

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Nasopharyngeal Cancinoma (NPC)

Treatments: Drug: Gargle with 2.5% sodium bicarbonate solution during radiotherapy; Drug: Gargle with 0.9% sodium chloride solution during radiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06854510

B2025-016-01

Details and patient eligibility

About

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.

Full description

With the improvement in the prognosis of locally advanced nasopharyngeal carcinoma (LA-NPC) patients, an increasing number of studys have turned their attention to the treatment-related toxicities in NPC patients. Common toxic reactions during the treatment of NPC patients include radiation-induced oral mucositis, radiation-induced skin injury, dysphagia, xerostomia, and hearing loss, etc. Among them, radiation - induced oral mucositis is one of the most common and severe complications during radiotherapy for NPC patients. More than half of LA-NPC will experience grade 3 - 4 radiation-induced oral mucositis.

Current international guidelines, including those from NCCN, ESMO, and the Multinational Association of Supportive Care in Cancer (MASCC), provisionally endorse sodium bicarbonate mouthwash as an adjunctive measure for RIOM management. The proposed mechanisms involve pH modulation of the oral cavity, microbial load reduction, and anti-inflammatory effects. Specifically: 1) NCCN guidelines incorporate sodium bicarbonate into multi-agent regimens with analgesics/anesthetics; 2) ESMO emphasizes its prophylactic potential in targeted therapy-associated mucositis; 3) MASCC consensus acknowledges its role in maintaining oral hygiene. However, these recommendations carry low evidence grades, with all guidelines explicitly highlighting the paucity of robust clinical data to substantiate efficacy claims.

To address this critical evidence gap, our research team proposes a randomized controlled trial to evaluate the efficacy of sodium bicarbonate mouthwash in mitigating RIOM severity throughout radiotherapy for LA-NPC. Given the current lack of high - level research evidence, the results of future research are expected to further confirm the effectiveness of sodium bicarbonate mouthwash in relieving radiation-induced oral mucositis during radiotherapy for NPC patients, improve the quality of life of NPC patients.

Enrollment: 196 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histopathologically confirmed nasopharyngeal carcinoma.
2. No evidence of distant metastasis (M0).
3. Scheduled to receive radical radiotherapy.
4. Karnofsky scale (KPS) > 70.
5. Age 18-70 years.
6. Capacity for independent oral rinse administration without dysphagia.

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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196 participants in 2 patient groups, including a placebo group

Sodium Bicarbonate Solution Gargle Group

Experimental group

Description:

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

Treatment:

Drug: Gargle with 2.5% sodium bicarbonate solution during radiotherapy

Sodium Chloride Solution Gargle Group

Placebo Comparator group

Description:

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

Treatment:

Drug: Gargle with 0.9% sodium chloride solution during radiotherapy