NCT02553863已完成不适用
A Randomised Controlled Trial to Assess the Effectiveness and Cost-effectiveness of Acupuncture in the Management of Chemotherapy-induced Peripheral Neuropathy
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 87
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
The purpose of this study is to determine whether a course of acupuncture is effective in the management of peripheral neuropathy related pain in patients receiving chemotherapy.
详细描述
Participants and settings:
- Patients with lung, breast, head & neck, colorectal or gynaecological cancer receiving taxanes or platinum-derivative chemotherapy experiencing CIPN after the end of cycle one will be the population of the study. The study will take place in a large cancer centre in the territory (Prince of Wales Hospital).
Recruitment:
- Potential subjects will be identified (through clinic lists and databases of patients who are undergoing treatment) and approached initially by the relevant clinical team and screening then undertaken by research staff. The trial will be run ethically, details of which process can be seen under additional material.
Randomisation:
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
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of lung cancer receiving chemotherapy with curative intend, and breast or gynaecological cancer, head & neck and colorectal cancer stage I, II or III.
- •Currently receiving neurotoxic chemotherapy (taxanes, cisplatin,,carboplatin, etc)
- •Reporting tingling in hands/feet and other indications of chemotherapy-induced peripheral neuropathy (CIPN) after initiation of cancer treatments, confirmed to be indicative of CIPN by a consultant.
- •Not using any medication for the prevention or treatment of CIPN for the past 31 months
- •Willing to participate and be randomised to one of the study groups.
- •No previously established peripheral neuropathy
排除标准
- •Exclusion criteria will include patients with needle phobia; Patients with low platelet count (<50,000); Comorbidity with a bleeding disorder; Pregnancy, or having received acupuncture treatment in the past three months. In addition, the ipsilateral arm of patients who have undergone axillary dissection will also be excluded from needling as well as lymphoedematous limbs.
研究组 & 干预措施
Intervention group
Experimental
Acupuncture for 30min [twice weekly for 8 weeks]
干预措施: Acupuncture (Procedure)
Control group
Other
Standard care
干预措施: Standard care (Procedure)
结局指标
主要结局
Pain
时间窗: at baseline, end of 8-week treatment, 14 weeks and 20 weeks (the latter two to assess possible longer term effects)
measured using the Brief Pain Inventory which measures pain intensity and its interference with function.
次要结局
- Measurement of costs(at baseline, end of 8-week treatment, 14 weeks and 20 weeks (the latter two to assess possible longer term effects))
- Severity of neuropathy(at baseline, end of 8-week treatment)
- Grade of CIPN(at baseline, end of 8-week treatment)
- Motor nerve conduction(at baseline, end of 8-week treatment)
- Quality of life(at baseline, end of 8-week treatment, 14 weeks and 20 weeks (the latter two to assess possible longer term effects))
- Sensory examination(at baseline, end of 8-week treatment)
- Consumption of analgesics(at baseline, end of 8-week treatment, 14 weeks and 20 weeks (the latter two to assess possible longer term effects))
研究者
Professor Alex MOLASIOTIS
Head of School, School of Nursing
The Hong Kong Polytechnic University
研究点 (2)
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