Acupuncture for Chemotherapy-induced Peripheral Neuropathy

NCT03582423 | Completed DMC

• 1 other identifier: HKBU-YCH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chemotherapy Induced Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Changes in scores of Functional Assessment of Cancer Therapy/Gynecology Oncology Group/Neurotoxicity (FACT/GOC-Ntx) questionnaire

  FACT/GOC-Ntx includes 11 questions covering sensory neuropathy, motor neuropathy, hearing neuropathy, and dysfunction associated with neuropathy. It results in a cumulative score ranging from 0 to 44, with the higher scores reflecting worse neuropathy symptoms. It will be assessed every week during 12-week treatment and the post-trial access will be performed at 15th, 18th, 21st and 24th week.

  0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks

Secondary Outcomes (6)

• Changes in scores of numerical rating scale (NRS) of numbness/pain score in hands and feet

  0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks

• Changes in scores of 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

• Changes in scores of Body Constitution of Chinese Medicine

  0,12,24 weeks

• Changes in response of vibration sense test

  0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks

• Changes in response of light touch test

  0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks

Study Arms (2)

electro-acupuncture group

EXPERIMENTAL

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.

Other: electro-acupuncture

sham-acupuncture group

PLACEBO COMPARATOR

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"

Other: electro-acupuncture

Interventions

electro-acupuncture OTHER

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.

electro-acupuncture group; sham-acupuncture group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hong Kong Baptist University: lead
• Princess Margaret Hospital, Hong Kong: collaborator

Study Sites (1)

Linda Zhong

Kowloon Tong, Kowloon, Hong Kong

Location

Related Publications (2)

• Chan K, Lui L, Lam Y, Yu K, Lau K, Lai M, Lau W, Tai L, Mak C, Bian Z, Zhong LL. Efficacy and safety of electroacupuncture for oxaliplatin-induced peripheral neuropathy in colorectal cancer patients: a single-blinded, randomized, sham-controlled trial. Acupunct Med. 2023 Oct;41(5):268-283. doi: 10.1177/09645284221125421. Epub 2022 Nov 3.

  PMID: 36325677 DERIVED

• Chan K, Lui L, Yu K, Lau K, Lai M, Lau W, Ng B, Zhong LLD, Bian ZX. The efficacy and safety of electro-acupuncture for alleviating chemotherapy-induced peripheral neuropathy in patients with coloreactal cancer: study protocol for a single-blinded, randomized sham-controlled trial. Trials. 2020 Jan 9;21(1):58. doi: 10.1186/s13063-019-3972-5.

  PMID: 31918748 DERIVED

Study Officials

• Bacon Ng, Ph.D

  Department of Chinese Medicine, Hospital Authority

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Subjects of both groups will be randomly assigned to receive either electro-acupuncture or control (sham) treatment. For randomization, simple, complete non-sequential random numbers will be generated in advance by a computer program in a block of four, and kept by the principal investigator. After a patient's eligibility is confirmed, a randomization number which corresponds to the group allocation will be provided to the acupuncturist by the PI. This arrangement will ensure that the clinical assessor and participants are blinded to the allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: single-blinded, randomized, sham-acupuncture controlled trial

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 11, 2018
• Study Start: October 22, 2018
• Primary Completion: August 31, 2020
• Study Completion: September 30, 2020
• Last Updated: October 9, 2020

Record last verified: 2020-10

Locations

HK (1)