Chinese Herbal Oral Solution and Mouthwash Shorten the Duration of Severe Radiotherapy-induced Oral Mucositis in Patients With Head and Neck Malignancies.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- The duration of severe oral mucositis (RTOG grade≥3)
研究概览
简要总结
Evaluate the effectiveness and safety of traditional Chinese medicine compound in improving radiotherapy-induced oral mucositis in patients with head and neck malignant tumors.
详细描述
The aim of this clinical trial is to evaluate the efficacy and safety of combining a traditional Chinese medicine (TCM) oral solution with a mouthwash in reducing the duration of severe radiation-induced oral mucositis (RIOM). The study addresses two primary questions: (1) whether the combined use of the TCM oral solution and mouthwash can effectively shorten the duration of severe RIOM, and (2) whether their use is associated with adverse events in patients undergoing radiotherapy.
Participants will initiate treatment on the first day they develop severe RIOM (RTOG grade ≥3) during radiotherapy. They will take Zishui Daohuo oral solution three times daily and use Kuju gargling solution six times daily, or matched placebos. Treatment will continue until two weeks after completion of radiotherapy. After each administration, patients must refrain from eating, drinking, or performing oral hygiene for at least one hour to maximize mucosal contact time.
The trial will compare the intervention group with the placebo group to determine the potential benefits of the combined regimen in improving RIOM.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
- •Age range: 18 to 65 years old (including 18 and 65 years old);
- •Eastern Cooperative Oncology Group performance status of ≤2;
- •Radiotherapy or concurrent chemoradiotherapy is required;
- •The main organ functions well;
- •Sign informed consent.
排除标准
- •Allergic constitution (such as those known to be allergic to two or more drugs);
- •Patients who plan to use drugs that can cause or worsen oral mucosal inflammation (such as anti EGFR monoclonal antibodies, immune checkpoint inhibitors, etc.) after the start of radiotherapy;
- •Use of antibiotics, antifungal drugs, or antimicrobial mouthwash within 1 month of the study;
- •Poor oral hygiene and/or severe periodontal diseases;
- •History of head and neck radiotherapy;
- •Deemed unsuitable for the study by the investigators (concomitant with any other severe diseases).
结局指标
主要结局
The duration of severe oral mucositis (RTOG grade≥3)
时间窗: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
The Radiation Therapy Oncology Group (RTOG) toxicity criteria were utilized to assess RIOM. Grade 0 shows no change from baseline; Grade 1 of RIOM is associated with mucosal erythema or hyperemiam,and may cause mild pain not requiring analgesics. Grade 2 presents with patchy mucositis that may produce an inflammatory serosanguinous discharge and may be associated with moderate pain; Grade 3 consists of confluent, fibrinous mucositis and may include severe pain requiring narcotics; Grade 4 is characterized by ulceration, hemorrhage, or necrosis. Grades 1 and 2 are considered mild to moderate, while grades 3 and 4 are classified as severe.
次要结局
- The time to onset of severe oral mucositis (RTOG grade≥3)(From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.)
- The duration of any-grade oral mucositis (OM)(From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.)
- The time to onset of any-grade oral mucositis (OM)(From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.)
- Relief rate of oral mucositis(From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.)
- Adverse events(From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks.)