Botulinum Toxin A as Treatment for Chronic Postsurgical Pain Following Lung Cancer Surgery: a Randomized Controlled Pilot Trial
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Rate of recruitment
研究概览
简要总结
Chronic postsurgical pain following lung cancer surgery is common with and 20-60 % develop chronic pain which persists more than six months after surgery. Causes and health impact of this pain have been comprehensively studied. Current treatment consists of combination of pain medication, physiotherapy and psychological therapy.
Botulinum Toxin A (BTX-A) has shown promising effects in a variety of chronic postsurgical pain syndromes. The use of BTX-A in lung cancer patients has only been presented in few case reports. No randomized controlled trials (RCT) have been executed to date.
Study objectives:
Determine recruitment potential among cured lung cancer patients with chronic postsurgical pain for an RCT and if the method of BTX-A administration is feasible and acceptable. Further more, this study will contribute to the stage testing of the hypothesis that chronic pain following thoracic surgery can be treated with BTX-A.
Methods:
Recruitment of test subjects:
Participiants are recruited among former lung cancer patients with chronic postsurgical pain, who have undergone radical treatment for lung cancer at the Department of Cardiothoracic Surgery, Aalborg University Hospital. Potential test subjects are invited by mail / e-mail.
Randomization and blinding:
Participants are randomized to receive a single series of subcutaneous injections with either Onabotulinum Toxin A (active agent) or inactive normal saline (Placebo) at the former operation site. Neither participant nor investigator will know which treatment is given until the end of the trial.
Data collection:
Data is collected by questionnaires delivered and answered by mail or digitally.
Data on the possible effects and possible adverse reactions are collected at multiple times until three months after treatment.
详细描述
Chronic postsurgical pain (CPP) following lung cancer surgery is common with an observed prevalence of 20-60 %. Causes and health impact have been comprehensively studied. Current treatment consists of combination of pain medication, physiotherapy and psychological therapy.
Botulinum Toxin A (BTX-A) has shown promising effects in a variety of chronic postsurgical pain syndromes. The use of BTX-A in lung cancer patients has only been presented in few case reports. No randomized clinical controlled trials (RCT) has been executed to date.
Study objectives:
Primary:
Determine recruitment potential among cured lung cancer patients with CPP for an RCT and if the method of BTX-A administration is feasible and acceptable to the test subjects.
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
- Double (Participant, Investigator)
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
- •Patients of 18 years of age or above.
- •Patients who have undergone pulmonary surgery because of suspicion or confirmed pulmonary malignancies.
- •Patients who are radically treated for pulmonary malignancy
- •Patients who suffers from chronic pain or unpleasant sensation at the site of scar at least six months after surgery with fully healed surgical wounds.
排除标准
- •Patients who cannot understand oral and written information.
- •Patients who were not radically operated.
- •Patients with other concomitant or other active cancer diseases.
- •Patients with chronic pain in the chest wall prior to surgery.
- •Pregnant women or women planning to get pregnant in the study period.
- •Patients with autoimmune neuromuscular diseases, sclerosis, peripheral neuromuscular disturbances and general muscle weakness or atrophy.
- •Patients with intolerance or allergy to BOTOX®.
- •Patients who are at present treated with BTX-A or similar neuromuscular blocking drug or have received such in the past year.
研究组 & 干预措施
BTX-A
Onabotulinum toxin A is reconstructed with 4 ml of normal saline in a vial containing 100 U (Allergen Units).
At a single treatment session, test subjects receive a series of subcutaneous injections with 2,5 U Onabotulinum toxin A equivalent to 0,1 ml of solution after reconstruction. One injection is given per 1 square centimeter in the painful area in relation to the scar on the chest wall. The maximum number of subcutaneous injections is 40, equivalent to a maximum dose of 100 U of Onabotulinum toxin in a total volume of 4 ml solution. The subcutaneous injections are administered using 26G 0.45 x 15 mm cannulae and 1 ml syringes.
干预措施: Onabotulinum Toxin A (Drug)
Placebo
At a single treatment session, test subjects receive a series of subcutaneous injections with one injection per 1 square centimeter in the painful area in relation to the scar on the chest wall with an inert solution, i.e. 0.1 ml injections of normal saline up to a total volume of 4 ml, depending on the area of the painful area. The subcutaneous injections are administered using 26G 0.45 x 15 mm cannulae and 1 ml syringes.
干预措施: Normal saline (Drug)
结局指标
主要结局
Rate of recruitment
时间窗: 12 months
Recruitment of 30 test subjects within twelve months.
Incidence of treatment procedure disruption
时间窗: 12 months
Proportion of test subjects terminating the treatment procedure after randomization by request due to unacceptable pain or discomfort during the procedure.
次要结局
- Activities of daily life(Baseline, 1 and 3 months)
- Neuropathic Pain Symptoms Inventory (NPSI)(Baseline, 1 and 3 moths after treatment)
- Patient's Global Impression of Change (PGIC)(1 and 3 months after treatment.)
- Pain at rest, coughing and when active(Weekly after treatment for three months)
- General Health(Baseline, 1 and 3 months after treatment)
- Pain at procedure(Baseline)
研究者
Allan Vestergaard Danielsen, MD
Principal Investigator
Aalborg University Hospital