The Efficacy and Safety of Acupuncture for Alleviating Chemotherapy-induced Peripheral Neuropathy in Colorectal Cancer Patients: a Pilot Single-blinded, Randomized Sham-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in scores of Functional Assessment of Cancer Therapy/Gynecology Oncology Group/Neurotoxicity (FACT/GOC-Ntx) questionnaire
研究概览
简要总结
In this study, a 24-week, single blinded, randomized controlled clinical trial will be conducted to examine the efficacy and safety of acupuncture for Chemotherapy Induced Peripheral Neuropathy (CIPN) in colorectal cancer patients in Hong Kong.
详细描述
This is a pilot single-blind, randomized, sham-controlled trial. 84 colorectal cancer patients will be randomly assigned to acupuncture group or control group. The duration of the treatment will be 12 weeks with 1 session per week and the follow-up period will be 12 weeks.
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 (Participant)
盲法说明
Subjects of both groups will be randomly assigned to receive either electro-acupuncture or control (sham) treatment. For randomization, simple, complete non-sequential random numbers will be generated in advance by a computer program in a block of four, and kept by the principal investigator. After a patient's eligibility is confirmed, a randomization number which corresponds to the group allocation will be provided to the acupuncturist by the PI. This arrangement will ensure that the clinical assessor and participants are blinded to the allocation.
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
- •aged ≥18 years old
- •newly diagnosed with stage Ⅱto Ⅲcolorectal cancer
- •who plan to receive 8 cycles of adjuvant oxaliplatin-based chemotherapy
- •who have not received any acupuncture
- •life expectancy of ≥ six months.
排除标准
- •uncooperative subjects
- •not be able to comprehend and communicate
- •non-Chinese reading people
- •having peripheral neuropathy caused by other diseases, for example, diabetes, stroke
- •heart disease, for example, arrhythmia, heart failure, myocardial infarction or patients with pacemakers
- •having a bleeding tendency
- •be pregnant or lactating women
- •having impaired hepatic or renal function
- •using any pharmaceutical agents (for example, gabapentin, pregabalin), nutraceutical agents (for example, vitamin B6, vitamin E) and herbal medication for CIPN treatment.
结局指标
主要结局
Changes in scores of Functional Assessment of Cancer Therapy/Gynecology Oncology Group/Neurotoxicity (FACT/GOC-Ntx) questionnaire
时间窗: 0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks
FACT/GOC-Ntx includes 11 questions covering sensory neuropathy, motor neuropathy, hearing neuropathy, and dysfunction associated with neuropathy. It results in a cumulative score ranging from 0 to 44, with the higher scores reflecting worse neuropathy symptoms. It will be assessed every week during 12-week treatment and the post-trial access will be performed at 15th, 18th, 21st and 24th week.
次要结局
- Changes in scores of numerical rating scale (NRS) of numbness/pain score in hands and feet(0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks)
- Changes in scores of European Organization for Research and Treatment of Cancer (EORCTC) Quality of Life Questionnaire (QLQ-C30)(0,3,6,9,12,15,18,21,24 weeks)
- Changes in scores of Body Constitution of Chinese Medicine(0,12,24 weeks)
- Adverse events after treatment and follow up(0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks)
- Changes in response of vibration sense test(0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks)
- Changes in response of light touch test(0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks)
研究者
Zhong Lidan
Research Assistant Professor
Hong Kong Baptist University