Acupuncture for Chemotherapy-induced Peripheral Neuropathy

Hong Kong Baptist University

Status: Completed

Conditions: Chemotherapy Induced Peripheral Neuropathy

Treatments: Other: electro-acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03582423

HKBU-YCH

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

electro-acupuncture group

Experimental group

Description:

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 occurs due to Capecitabine (Xeloda).Disposable acupuncture needles will be inserted at a depth of 10-25mm into the points. We will deliver electrical stimulation with continuous waves at 2 Hz, at an intensity of each patient's minimum sensation of stimulation through the electrical acupuncture stimulation instrument to the points. The needles will be retained in position for 25 minutes.

Treatment:

Other: electro-acupuncture

sham-acupuncture group

Placebo Comparator group

Description:

Streitberger's non-invasive acupuncture needles (Gauge 8 × 1.2"/ 0.30 × 30mm) will be applied to serve as a sham control at the same acupoints with the same stimulation modality, except that the needles are only adhered to the skin by a small plastic ring instead of being inserted and the stimulation will be a "pseudo-stimulation"

Treatment:

Other: electro-acupuncture