Electro-acupuncture for the Prevention and Treatment of Oxaliplatin-induced Neurotoxicity in Colorectal Cancer Patients: a Prospective, Randomized, Sham-controlled, Double-blinded and Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Score Changes on the FACT/GOG-Ntx questionnaire
研究概览
简要总结
In this study, a 24-week randomized, sham-controlled, single-blind, multicenter clinical trial will be conducted to explore the effect of electroacupuncture for prevention and treatment of both acute and chronic neurotoxicity through both clinical and biological indicators.
详细描述
This is a prospective, randomized, sham-controlled, double-blinded and multiple center trial on electro-acupuncture for preventing and treating symptoms of chemotherapy-induced neurotoxicity in patients with colorectal cancer. A total of 150 candidates will be recruited in this study four weeks before chemotherapy for best preventive effect. They will be assigned randomly into either the electro-acupuncture or the sham-control group with 1:1 ratio. Both groups will receive a total of 24 sessions of interventions (4 weeks before chemotherapy and 8 weeks during chemotherapy, with 2 session per week), and will be followed up regularly for up to 12 weeks after completion of the acupuncture.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
All patients and the investigators including the research assessors, the statistician, and the researchers interacting with the patients except the one who conducts the acupuncture therapy will be blinded.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •are aged ≥18 years old;
- •are newly diagnosed with stage II to IV colorectal cancer;
- •going to receive adjuvant oxaliplatin-based chemotherapy within 4 weeks;
- •had not received any acupuncture in the previous 3 months and had a life expectancy ≥ of six months.
排除标准
- •are not able to comprehend and communicate;
- •are not able to read Chinese;
- •have prior peripheral neuropathy caused by other diseases including diabetes, stroke, cardiovascular diseases such as arrhythmia, heart failure, myocardial infarction, and patients with cardiac pacemakers;
- •have a bleeding tendency;
- •are pregnant or breastfeeding;
- •have impaired hepatic or renal function;
- •using any pharmaceutical agents e.g., vitamin B6 and vitamin E, or herbal medication. All the above medication prescribed by physicians or Chinese medicine practitioners during the study will be recorded.
结局指标
主要结局
Score Changes on the FACT/GOG-Ntx questionnaire
时间窗: 0-24 weeks; weekly
The questionnaire includes 11 questions covering sensory neuropathy, motor neuropathy, hearing neuropathy, and dysfunction associated with neuropathy, which results in a cumulative score ranging from 0 to 44, with the lower scores reflecting worse neuropathy symptoms.
次要结局
- Vibration sense test(0-12 week; weekly)
- 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)
- Light touch test(0-12 week; weekly)
- Constitution of Chinese Medicine Questionnaire (CCMQ)(0,12,24 weeks)
- numerical rating scale (NRS)(0-24 weeks; weekly)
- Short Form 12 item(version 2) Health Survey (SF-12V2)(0-12 week; weekly)
研究者
Zhong Lidan
Associate Professor
Hong Kong Baptist University