Botulinum toxin A in the Treatment of Chronic Postsurgical Pain in Lung Cancer Patients: A feasibility study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Inclusion of a minimum of 15 participants within the study period.
研究概览
简要总结
The objective of this trial is to assess the feasibility of conducting a full-scale clinical trial investigating BTX-A for established CPSP following lung cancer surgery.
The trial also aim to explore proof of concept for analgesic effect of BTX-A in surgical lung cancer patients.
Primary objectives:
- Establish the rate of recruitment.
- Establish the percentage of screened patients recruited.
- Determine study completion percentage.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Patients who have undergone curative lung cancer surgery with or without (neo)adjuvant therapy.
- •Patients diagnosed with chronic postsurgical pain following lung cancer surgery, according to current criteria defined by the International Association for the Study of Pain.
- •Report at least moderate pain (defined as ≥4 on a numerical rating scale (NRS) from 0 (no pain) to 10 (worst pain imaginable) AND/OR presence of neuropathic pain assessed by Douleur Neuropathique 4 Questions (DN4), defined as a score of ≥4/
- •Able to understand, speak and read Danish.
- •Females of childbearing age/premenopausal must use a safe and approved contraceptive treatment.
排除标准
- •Individuals unable to understand oral and written information.
- •Pregnant females, lactating females, females planning pregnancy, and fertile females not using contraception (hormonal contraceptives or an intrauterine device).
- •Patients who, according to the final histopathological report, were not radically treated for their lung cancer.
- •Patients undergoing examinations or treatments for other concurrent or newly diagnosed cancers.
- •Patients with a pre-existing chronic pain condition in the chest area before surgery.
- •Patients with autoimmune neuromuscular diseases, multiple sclerosis, peripheral neuromuscular disorders, or severe generalized muscle weakness or atrophy.
- •Patients with hypersensitivity or allergy to BTX-A.
- •Patients currently receiving BTX-A treatment or those who have received BTX-A within the past year.
- •Psychiatric comorbidities deemed by the investigators to impact the ability to participate.
- •Active abuse of illicit drugs.
研究组 & 干预措施
Xeomin, pulver til injektionsvæske, opløsning 100 enheder
干预措施: Xeomin, pulver til injektionsvæske, opløsning 100 enheder (Drug)
结局指标
主要结局
Inclusion of a minimum of 15 participants within the study period.
Inclusion of a minimum of 15 participants within the study period.
Determination of percentage of patients eligible for recruitment who are enrolled and the rate of enrolment.
Determination of percentage of patients eligible for recruitment who are enrolled and the rate of enrolment.
Recording of reasons for declining study participation, if possible.
Recording of reasons for declining study participation, if possible.
Determination of percentage of completion.
Determination of percentage of completion.
次要结局
- Testing of practical feasibility of the administration method by subcutaneous BTX-A injections in the chest wall evaluated by the percentages of participants completing the intended intervention.
- Evaluation of tolerability of the intervention during administration and possible side effects/adverse events during follow-up.
- Determination of questionnaire completion and participation rates at each follow-up assessment time point.
- Evaluation of “proof of concept” for subcutaneous BTX-A as pain relief in chronic postsurgical pain following surgery for lung cancer, specifically.
研究者
Clinical trial contact person
Scientific
Aalborg University Hospital