EUCTR2020-003300-14-DK进行中(未招募)1 期
Botulinum Toxin A as Treatment for Chronic Postsurgical Pain Following LungCancer Surgery: a Randomized Controlled Pilot Trial
Department of Cardiothoracic Surgery, Aalborg Universityhospital0 个研究点目标入组 30 人开始时间: 2020年8月14日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients of 18 years of age or above.
- •2. Patients who have undergone pulmonary surgery because of suspicion
- •or confirmed pulmonary malignancies.
- •3. Patients who are radically treated for pulmonary malignancy
- •4. Patients who suffers from chronic pain or unpleasant sensations at the site of scar at least six months after surgery with fully healed surgical wounds.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Patients who cannot understand oral and written information.
- •2. Patients who were not radically operated.
- •3. Patients with other concomitant or other active cancer diseases.
- •4. Patients with chronic pain in the chest wall prior to surgery.
- •5. Pregnant women or women planning to get pregnant in the study period.
- •6. Patients with autoimmune neuromuscular diseases, sclerosis, peripheral
- •neuromuscular disturbances and general muscle weakness or atrophy.
- •7. Patients with intolerance or allergy to BOTOX®.
- •8. Patients who are at present treated with Onabotulinum toxin A or similar neuromuscular blocking drug or have received such in the past year.
研究者
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