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Acupuncture for Chemotherapy-induced Peripheral Neuropathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03582423
Recruitment Status : Completed
First Posted : July 11, 2018
Last Update Posted : October 9, 2020
Sponsor:
Collaborator:
Princess Margaret Hospital, Hong Kong
Information provided by (Responsible Party):
Zhong Lidan, Hong Kong Baptist University

Tracking Information
First Submitted Date  ICMJE June 18, 2018
First Posted Date  ICMJE July 11, 2018
Last Update Posted Date October 9, 2020
Actual Study Start Date  ICMJE October 22, 2018
Actual Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2018)		 Changes in scores of Functional Assessment of Cancer Therapy/Gynecology Oncology Group/Neurotoxicity (FACT/GOC-Ntx) questionnaire [ Time Frame: 0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 9, 2018)		 Changes in scores of Functional Assessment of Cancer Therapy/Gynecology Oncology Group/Neurotoxicity (FACT/GOC-Ntx) questionnaire [ Time Frame: 24 weeks ]
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2018)
  • Changes in scores of numerical rating scale (NRS) of numbness/pain score in hands and feet [ Time Frame: 0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks ]
    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) [ Time Frame: 0,3,6,9,12,15,18,21,24 weeks ]
    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 [ Time Frame: 0,12,24 weeks ]
    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 [ Time Frame: 0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks ]
    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 [ Time Frame: 0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks ]
    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 [ Time Frame: 0,1,2,3,4,5,6,7,8,9,10,11,12,15,18,21,24 weeks ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2018)
  • Changes in scores of numerical rating scale (NRS) of numbness/pain score in hands and feet [ Time Frame: 24 weeks ]
    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) [ Time Frame: 24 weeks ]
    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 [ Time Frame: 24 weeks ]
    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 [ Time Frame: 24 weeks ]
    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 [ Time Frame: 24 weeks ]
    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 [ Time Frame: 24 weeks ]
    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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acupuncture for Chemotherapy-induced Peripheral Neuropathy
Official Title  ICMJE The Efficacy and Safety of Acupuncture for Alleviating Chemotherapy-induced Peripheral Neuropathy in Colorectal Cancer Patients: a Pilot Single-blinded, Randomized Sham-controlled Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
single-blinded, randomized, sham-acupuncture controlled trial
Masking: Single (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.
Primary Purpose: Treatment
Condition  ICMJE Chemotherapy Induced Peripheral Neuropathy
Intervention  ICMJE Other: electro-acupuncture
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.
Study Arms  ICMJE
  • Experimental: electro-acupuncture group
    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.
    Intervention: Other: electro-acupuncture
  • Placebo Comparator: sham-acupuncture group
    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: Other: electro-acupuncture
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 8, 2020)		 60
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2018)		 84
Actual Study Completion Date  ICMJE September 30, 2020
Actual Primary Completion Date August 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03582423
Other Study ID Numbers  ICMJE HKBU-YCH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Zhong Lidan, Hong Kong Baptist University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Hong Kong Baptist University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Princess Margaret Hospital, Hong Kong
Investigators  ICMJE
Study Director: Bacon Ng, Ph.D Department of Chinese Medicine, Hospital Authority
PRS Account Hong Kong Baptist University
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP