CTRI/2024/04/065944尚未招募2 期
Assessing topical methylene blue efficacy for radiation-induced oral mucositis pain: a single arm phase ii clinical trial.
Navas Bright1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2024年4月26日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Evaluate pain relief with topical methylene blue 0.025% in patients with radiation-induced oral mucositis.
研究概览
简要总结
Radiation is one of the primary treatments for head and neck cancer, but it also contributes to mucositis, resulting in pain and a diminished quality of life. Pain management typically involves the use of topical agents and systemic opioids. The rationale for this study is to investigate the effectiveness of a novel topical agent, methylene blue, in alleviating pain caused by radiation-induced mucositis, with the ultimate goal of reducing the need of systemic opioids.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age more than 18 years
- •Oral cavity and oropharynx cancer patients receiving radiation or chemoradiation
- •Oral cavity pain with NRS ≥4 and not on analgesic for oral pain.
- •Pain score more ≥7, with or without analgesia for oral pain
- •Any grade of oral mucositis
- •All stages of cancer with cancer-related pain adequately controlled before radiation
- •Voluntary written consent.
排除标准
- •1.Oro-cutaneous fistula 2.Inability to rinse/gargle/no mouth opening 3Known allergy to methylene blue 4.Cognitive impairment and inability to consent 5.Confused/ agitated patient 6.Patient with cognitive impairment 7.Patients undergoing re-radiation.
结局指标
主要结局
Evaluate pain relief with topical methylene blue 0.025% in patients with radiation-induced oral mucositis.
时间窗: baseline, 1st hour, every day once for 2 weeks,then alternate day for 2 weeks.
次要结局
- 1.Oral functioning of the patient with radiation induced OM on methylene blue rinse.(2.Dose of systemic analgesics and adjuvants in patients receiving methylene blue.)
研究者
Navas Bright
Cancer Institute (WIA)
研究点 (1)
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