Using sodium bicarbonate mouthwash to reduce oral mucositis in nasopharyngeal cancer patients during radiotherapy

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

This study is testing if a sodium bicarbonate mouthwash can help people with nasopharyngeal cancer feel less pain from mouth sores caused by radiation treatment.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 196 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sun Yat-sen University (other)
• Drugs / interventions: chemotherapy, Radiation
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06854510 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of a 2.5% sodium bicarbonate mouthwash in reducing the severity of radiation-induced oral mucositis in patients undergoing radiotherapy for nasopharyngeal carcinoma. The study aims to determine if this mouthwash can improve patient adherence to treatment by alleviating one of the most common and severe complications associated with radiotherapy. Participants will be randomly assigned to gargle with either sodium bicarbonate or a saline solution during their treatment. The trial addresses a significant gap in clinical evidence regarding the management of oral mucositis in this patient population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with histopathologically confirmed nasopharyngeal carcinoma scheduled for radical radiotherapy and capable of independent oral rinse administration.

Not a fit: Patients with pre-existing oral mucosal disorders, those receiving non-platinum-based chemotherapy, or those with severe coexisting illnesses may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce the incidence and severity of oral mucositis, improving the quality of life for patients undergoing radiotherapy.

How similar studies have performed: While sodium bicarbonate mouthwash is provisionally endorsed by international guidelines, robust clinical data supporting its efficacy is limited, making this approach relatively novel.

Eligibility criteria

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.

Where this trial is running

Guangzhou, Guangdong

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (RECRUITING)

Study contacts

• Study coordinator: Ling-Long Tang

Conditions: Nasopharyngeal Cancinoma