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Acupuncture for Chemotherapy-induced Peripheral Neuropathy

Primary Purpose

Chemotherapy Induced Peripheral Neuropathy

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
electro-acupuncture
Sponsored by
Hong Kong Baptist University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chemotherapy Induced Peripheral Neuropathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Linda Zhong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

electro-acupuncture group

sham-acupuncture group

Arm 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.

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"

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Changes in scores of numerical rating scale (NRS) of numbness/pain score in hands and feet
patients will be asked to rate their average neuropathy symptoms within one week, on an 0 to 10 scale (0 = no symptoms; 10 = worst possible symptoms), those <4 of 10 NRS will be considered as mild CIPN while ≥4 of 10 NRS will be considered as moderate to severe CIPN. 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.
Changes in scores of European Organization for Research and Treatment of Cancer (EORCTC) Quality of Life Questionnaire (QLQ-C30)
It is a 30-items questionnaire assessing five functional scales (physical, role, cognitive, emotional and social), three symptoms scales (fatigue, pain, nausea and vomiting), and other symptoms and problem in cancer patients (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties).It will be assessed every 3 weeks during 12-week treatment and the post-trial access will be performed at 15th, 18th, 21st and 24th week.
Changes in scores of Body Constitution of Chinese Medicine
Constitution of Chinese Medicine Questionnaire has 60 items measuring the 9 body constitution types: gentleness, Qi-deficiency, Yang-deficiency, Yin-deficiency, phlegm-wetness, wetness- heat, blood-stasis, Qi-depression, and special diathesis. It will be assessed at the end of treatment (12th week) and at the end of follow-up (24th week).
Changes in response of vibration sense test
It is assessed by using the graduated Rydel-Seiffer tuning fork. 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.
Changes in response of light touch test
It is assessed with standard 10g monofilaments, contained within the Neuropen. 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.
Adverse events after treatment and follow up
Adverse events after treatment will be recorded and compared among the two groups. 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.

Full Information

First Posted
June 18, 2018
Last Updated
October 8, 2020
Sponsor
Hong Kong Baptist University
Collaborators
Princess Margaret Hospital, Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT03582423
Brief Title
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

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
October 22, 2018 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hong Kong Baptist University
Collaborators
Princess Margaret Hospital, Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy Induced Peripheral Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single-blinded, randomized, sham-acupuncture controlled trial
Masking
Participant
Masking Description
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.
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
electro-acupuncture group
Arm Type
Experimental
Arm 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.
Arm Title
sham-acupuncture group
Arm Type
Placebo Comparator
Arm 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"
Intervention Type
Other
Intervention Name(s)
electro-acupuncture
Intervention 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.
Primary Outcome Measure Information:
Title
Changes in scores of Functional Assessment of Cancer Therapy/Gynecology Oncology Group/Neurotoxicity (FACT/GOC-Ntx) questionnaire
Description
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.
Time Frame
0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks
Secondary Outcome Measure Information:
Title
Changes in scores of numerical rating scale (NRS) of numbness/pain score in hands and feet
Description
patients will be asked to rate their average neuropathy symptoms within one week, on an 0 to 10 scale (0 = no symptoms; 10 = worst possible symptoms), those <4 of 10 NRS will be considered as mild CIPN while ≥4 of 10 NRS will be considered as moderate to severe CIPN. 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.
Time Frame
0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks
Title
Changes in scores of European Organization for Research and Treatment of Cancer (EORCTC) Quality of Life Questionnaire (QLQ-C30)
Description
It is a 30-items questionnaire assessing five functional scales (physical, role, cognitive, emotional and social), three symptoms scales (fatigue, pain, nausea and vomiting), and other symptoms and problem in cancer patients (dyspnea, appetite loss, insomnia, constipation, diarrhea, and financial difficulties).It will be assessed every 3 weeks during 12-week treatment and the post-trial access will be performed at 15th, 18th, 21st and 24th week.
Time Frame
0,3,6,9,12,15,18,21,24 weeks
Title
Changes in scores of Body Constitution of Chinese Medicine
Description
Constitution of Chinese Medicine Questionnaire has 60 items measuring the 9 body constitution types: gentleness, Qi-deficiency, Yang-deficiency, Yin-deficiency, phlegm-wetness, wetness- heat, blood-stasis, Qi-depression, and special diathesis. It will be assessed at the end of treatment (12th week) and at the end of follow-up (24th week).
Time Frame
0,12,24 weeks
Title
Changes in response of vibration sense test
Description
It is assessed by using the graduated Rydel-Seiffer tuning fork. 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.
Time Frame
0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks
Title
Changes in response of light touch test
Description
It is assessed with standard 10g monofilaments, contained within the Neuropen. 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.
Time Frame
0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks
Title
Adverse events after treatment and follow up
Description
Adverse events after treatment will be recorded and compared among the two groups. 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.
Time Frame
0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bacon Ng, Ph.D
Organizational Affiliation
Department of Chinese Medicine, Hospital Authority
Official's Role
Study Director
Facility Information:
Facility Name
Linda Zhong
City
Kowloon Tong
State/Province
Kowloon
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36325677
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.
Results Reference
derived
PubMed Identifier
31918748
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.
Results Reference
derived

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Acupuncture for Chemotherapy-induced Peripheral Neuropathy

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