Clinical Trial With Lozenges as Local Anesthetic Treatment for Head/Neck Cancer Patients With Oral Mucositis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Reduction of oral and pharyngeal pain measured on Visual Analogue Scale (VAS)
研究概览
简要总结
Oral mucositis is a damage to the mucosa of the oral cavity and pharynx. It is a serious and painful adverse effect caused by the radio therapy and/or chemo therapy patients with head and neck cancer receive. The pain caused by oral mucositis can be difficult to treat as the current treatment with opioids is not sufficient and can cause adverse effects.
Our hypothesis is that treatment with a local anesthetic lozenge with bupivacaine can reduce the oral pain caused by mucositis compared with the current standard treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with head/neck cancer and starting radio therapy treatment
- •age between 18 and 80 years (both included)
- •able to talk, read and understand Danish
- •ability to give informed consent
排除标准
- •known hypersensitivity towards bupivacaine or other local anesthetics of the amide type
- •pregnancy
- •women breastfeeding a child
研究组 & 干预措施
Bupivacaine lozenge
The patients can take up to eight 25 mg bupivacaine lozenges (max. every second hour in the awake hours) a day for seven days. The patients can use concomitant systemic pain treatment (e.g. morphine).
干预措施: Bupivacaine (Drug)
Standard treatment
The patients will be treated with the currently used standard pain treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin). The anesthetics are being administered at the physician's discretion.
干预措施: Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin) (Drug)
结局指标
主要结局
Reduction of oral and pharyngeal pain measured on Visual Analogue Scale (VAS)
时间窗: 7 days
The primary outcome measure is the mean VAS score for the patients in the bupivacaine lozenge group compared with the mean VAS score for the patients in the standard treatment group. The lozenge group measures VAS before and 60 min. after administration of a lozenge for seven days. The standard treatment group measures VAS every second hour for seven days.
次要结局
- Effect of the bupivacaine lozenge(7 days)
- Safety: Peak plasma concentrations of bupivacaine(90 minutes)
- Duration of the effect of the lozenge(7 days)
研究者
Claus Andrup Kristensen
MD, PhD
Rigshospitalet, Denmark