Electro-acupuncture for the Prevention and Treatment of Oxaliplatin-induced Neurotoxicity in Colorectal Cancer Patients

Hong Kong Baptist University

Status: Not yet enrolling

Conditions: Oxaliplatin; Neurotoxicity; Electro-acupuncture; Colorectal Cancer

Treatments: Device: Sham-acupuncture; Device: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT05798884

2020HMRF

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 2 patient groups

Electro-acupuncture group

Experimental group

Description:

The electro-acupuncture intervention will be conducted for 2 sessions per week for 4 consecutive weeks before and 8 weeks during the chemotherapy. In this study eight acupoints are chosen: he gu (LI4), nei guan (PC6), qu chi (LI12), ba xie (EX-UE9), zu san li (ST36), san yin jiao (SP6), tai chung (LV3) and ba feng (EX-LE10). The use of ba xie (EX-UE9) and ba feng (EX-LE10) will be optional if skin lesions of hands and feet occur due to Capecitabine (Xeloda). Disposable acupuncture needles (verum acupuncture needles Hwato 0.25 x 25mm matching the Streiterger sham needles) will be inserted at a depth of 10-25mm into the points. Electrical stimulation will be delivered with continuous waves at 2 Hz, at an intensity of each patient's minimum sensation of stimulation through the electrical acupuncture stimulation instrument. The needles will be retained in position for 25 minutes.

Treatment:

Device: Acupuncture

sham-acupuncture group

Sham Comparator group

Description:

For subjects assigned to the sham control group, Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2"/ 0.30 x 30mm) will be applied to serve as a sham control at the same acupoints with the same stimulation modality, and the stimulation will be a "pseudo stimulation", which will be given by connecting the needle to the incorrect output socket of the electrical acupuncture stimulation instrument.The credibility and validity of this system have been well demonstrated.

Treatment:

Device: Sham-acupuncture