Clinical trial NCT05798884: Electro-acupuncture for the Prevention and Treatment of Oxaliplatin-induced Neurotoxicity in Colorectal Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Oxaliplatin
Electro-acupuncture
Neurotoxicity
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Hong Kong
name: Queen Mary Hospital, Hong Kong
First posted: 2023-04-05
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Score Changes on the FACT/GOG-Ntx questionnaire
timeFrame: 0-24 weeks; weekly
Secondary outcomes:
measure: numerical rating scale (NRS)
timeFrame: 0-24 weeks; weekly
measure: European Organization for Research and Treatment of Cancer (EORCTC) quality of life questionnaire QLQ-C30
timeFrame: 0,3,6,9,12,15,18,21,24 weeks
measure: Constitution of Chinese Medicine Questionnaire (CCMQ)
timeFrame: 0,12,24 weeks
measure: Vibration sense test
timeFrame: 0-12 week; weekly
measure: Light touch test
timeFrame: 0-12 week; weekly
measure: Short Form 12 item(version 2) Health Survey (SF-12V2)
timeFrame: 0-12 week; weekly
Other outcomes:
Locations:
city: Kowloon Tong
country: Hong Kong
facility: Linda Zhong
state: Kowloon
Study officials:
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