NCT05878405已完成3 期
Methylene Blue Mouthwash for Oral Mucositis Pain in Cancer: An Open-Label, Non-Randomized, Controlled Study
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Change in oral pain
研究概览
简要总结
This phase III trial compares the effect of methylene blue mouthwash to standard of care mouthwash for the treatment of oral mucositis pain in patients with cancer. Using methlylene blue mouthwash may improve oral pain in patients with oral mucositis related to cancer and/or cancer treatments compared to usual standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active cancer diagnosis
- •Admitted to the inpatient setting
- •Pain related to oral mucositis
- •Experiencing oropharyngeal pain
- •Able to provide informed consent
排除标准
- •Pediatric age (under 18 years old)
- •Pregnant or nursing women
- •Any contraindication to methylene blue including severe hypersensitivity to methylene blue and patients with glucose-6-phosphate dehydrogenase deficiency (G6PD) due to the risk of hemolytic anemia
结局指标
主要结局
Change in oral pain
时间窗: Baseline, 3 days
Pain will be assessed using the standard institutional numeric rating scale where pain level is quantified on a scale of 0 (no pain) to 10 (worst possible pain) pre- and post-intervention (3 times daily for 3 days). Last collected scores will be compared to baseline.
次要结局
- Change in the amount of oral intake(Baseline, 3 days)
- Change in the amount of daily requirements of oral morphine equivalents(Baseline, 3 days)
研究者
研究点 (2)
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