Clinical trial NCT03582423: Acupuncture for Chemotherapy-induced Peripheral Neuropathy
Official title: The Efficacy and Safety of Acupuncture for Alleviating Chemotherapy-induced Peripheral Neuropathy in Colorectal Cancer Patients: a Pilot Single-blinded, Randomized Sham-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chemotherapy Induced Peripheral Neuropathy
Lead sponsor: Hong Kong Baptist University
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Hong Kong
First posted: 2018-07-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-blinded, randomized, sham-acupuncture controlled trial
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in scores of Functional Assessment of Cancer Therapy/Gynecology Oncology Group/Neurotoxicity (FACT/GOC-Ntx) questionnaire
timeFrame: 0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks
Secondary outcomes:
measure: Changes in scores of numerical rating scale (NRS) of numbness/pain score in hands and feet
timeFrame: 0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks
measure: Changes in scores of 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: Changes in scores of Body Constitution of Chinese Medicine
timeFrame: 0,12,24 weeks
measure: Changes in response of vibration sense test
timeFrame: 0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks
measure: Changes in response of light touch test
timeFrame: 0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks
measure: Adverse events after treatment and follow up
timeFrame: 0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks
Other outcomes:
Locations:
city: Kowloon Tong
country: Hong Kong
facility: Linda Zhong
state: Kowloon
Study officials:
affiliation: Department of Chinese Medicine, Hospital Authority
name: Bacon Ng, Ph.D
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.