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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Cancer
- Sponsor
- Hong Kong Baptist University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Score Changes on the FACT/GOG-Ntx questionnaire
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Zhong Lidan
Associate Professor
Hong Kong Baptist University
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Score Changes on the FACT/GOG-Ntx questionnaire
Time Frame: 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.
Secondary Outcomes
- 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)