A Prospective, Single-Center, Randomized Controlled Study on Sodium Bicarbonate Mouthwash for the Prevention and Treatment of Radiation-Induced Oral Mucositis in Nasopharyngeal Carcinoma.
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 196
- 试验地点
- 1
- 主要终点
- The incidence of grade ≥2 oral mucositis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologically confirmed nasopharyngeal carcinoma.
- •No evidence of distant metastasis (M0).
- •Scheduled to receive radical radiotherapy.
- •Karnofsky scale (KPS) >
- •Age 18-70 years.
- •Capacity for independent oral rinse administration without dysphagia.
排除标准
- •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.
研究组 & 干预措施
Sodium Bicarbonate Solution Gargle Group
Oral rinses using 2.5% sodium bicarbonate solution were administered daily throughout the radiotherapy course
干预措施: Gargle with 2.5% sodium bicarbonate solution during radiotherapy (Drug)
Sodium Chloride Solution Gargle Group
Oral rinses using 0.9% sodium chloride solution were administered daily throughout the radiotherapy course
干预措施: Gargle with 0.9% sodium chloride solution during radiotherapy (Drug)
结局指标
主要结局
The incidence of grade ≥2 oral mucositis
时间窗: from radiotherapy commencement until 14 days post-radiotherapy
Oral mucositis grade was evaluated using RTOG (Radiation Therapy Oncology Group) criteria, with intergroup differences analyzed by Chi-square test.
次要结局
- 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)
研究者
Ling-Long Tang
Prof.
Sun Yat-sen University