Randomized, Assessor- and Participant-blinded, Controlled, and Parallel-design Approach to Investigate Whether Acupuncture Can Prevent or Postpone the Occurrence of Peripheral Neuropathy and Improve Quality of Life.
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change from Baseline in NCV at 48weeks.
研究概览
简要总结
The aim of this pilot study is to investigate the efficacy of acupuncture in prevention of chemotherapy induced peripheral neuropathy. The study adapted a single center, randomized, assessor- and participant-blinded, controlled, and parallel-design approach to investigate whether acupuncture can prevent or postpone the occurrence of peripheral neuropathy and improve quality of life.
详细描述
Background and purpose:
Chemotherapy-induced peripheral neuropathy (CIPN) is a disabling side effect of several commonly used antineoplastic agents. CIPN prevalence was 68.1% within the first month of the end of chemotherapy, 60% at 3 months, and 30.0% at 6 months or later. Oxaliplatin as a chemotherapeutic drug for colorectal cancer has neurotoxicity on peripheral nerve system. A definite portion of patients suffered neurologic symptoms including paresthesia, dysesthesia over limbs and perioral area accompanied with muscles cramps or spasm sometimes; however, had impact on quality of life, daily functions, quality of sleep and lead to distress and depression. There is no drug to prevent peripheral neuropathy. Clinical observations reveal that acupuncture could decrease peripheral neuropathy, improve quality of life, and promote motivation of complete chemotherapy course.
Material and methods:
A total of 32 volunteers of patients with colorectal cancer will be recruited from the Chinese medicine or Western medicine clinics in China Medical University Hospital. These patients will be randomized to receive verum acupuncture or sham acupuncture treatment two times biweekly, prior to beginning chemotherapy and the weeks that drugs administered, for 26 treatments in total.
Questionnaires, neurological examination and Von Frey Filament Test will be completed at baseline, 12 and 24 weeks after initiation of intervention, 12 and 24 weeks after completion of acupuncture completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients were diagnosed as stage 3 colorectal cancer.
- •Patients are going to receive Oxaliplatin based chemotherapy.
- •Patients are willing to cooperate with physicians and completely receive chemotherapy.
- •Patients are willing to receive acupuncture treatments and follow-up assessments.
- •Adult volunteers with the ages of 20-70 years old.
- •ECOG Performance Status of 0, 1, or 2
排除标准
- •Current active treatments with chemotherapy, radiotherapy or tumor resection surgery in the past one month.
- •Having chemotherapy with neuropathic agents including taxane, platinum, vinca alkaloid, bortezimab, or thalidomide in the past six months.
- •Local infection at or near the acupuncture site is not suitable for acupuncture after physician examination.
- •Concurrent use of other alternative medicines such as herbal agents, high dose vitamins and minerals.
- •Known coagulopathy or taking anticoagulants.
- •Platelets < 50000/ul.
- •WBCs < 3000/ul.
- •Active CNS disease
- •Cardiac pacemaker.
- •Psychological or behavior disorder such as Schizophrenia.
- •Currently pregnant or breastfeeding women.
- •History of diabetic neuropathy or neuropathy related to HIV.
- •Previous acupuncture treatment for any indication within 30 days of enrollment.
- •Current medications that could affect symptoms related to CIPN.
- •Grade III lymphedema or more severe situation
研究组 & 干预措施
Verum acupuncture
16 patients will be randomized to receive verum acupuncture two times biweekly, prior to beginning chemotherapy and the weeks that drugs administered, for 26 treatments in total.
干预措施: Verum acupuncture (Other)
Sham acupuncture
16 patients will be randomized to receive sham acupuncture two times biweekly, prior to beginning chemotherapy and the weeks that drugs administered, for 26 treatments in total.
干预措施: Verum acupuncture (Other)
结局指标
主要结局
Change from Baseline in NCV at 48weeks.
时间窗: Baseline, 12 and 24 weeks after initiation of intervention, 12 and 24 weeks after completion of acupuncture completion.
Change from Baseline in Von frey filament test at 48weeks.
时间窗: Baseline, 12 and 24 weeks after initiation of intervention, 12 and 24 weeks after completion of acupuncture completion.
次要结局
- Change from Baseline in questionnaire - FACT/GOG-Ntx Subscale at 48weeks.(Baseline, 12 and 24 weeks after initiation of intervention, 12 and 24 weeks after completion of acupuncture completion.)
- Change from Baseline in questionnaire - FACT-G at 48weeks.(Baseline, 12 and 24 weeks after initiation of intervention, 12 and 24 weeks after completion of acupuncture completion.)
- Change from Baseline in questionnaire - Brief Pain Inventory Short Form at 48weeks.(Baseline, 12 and 24 weeks after initiation of intervention, 12 and 24 weeks after completion of acupuncture completion.)
研究者
Tzu-Liang Chen
Deputy Superintendent of the Surgery department
China Medical University Hospital