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Acupuncture for Chemotherapy-induced Peripheral Neuropathy

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ClinicalTrials.gov Identifier: NCT03582423
Recruitment Status : Not yet recruiting
First Posted : July 11, 2018
Last Update Posted : July 16, 2018
Sponsor:
Collaborator:
Princess Margaret Hospital, Hong Kong
Information provided by (Responsible Party):
Zhong Lidan, Hong Kong Baptist University

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.

Condition or disease Intervention/treatment Phase
Chemotherapy Induced Peripheral Neuropathy Other: electro-acupuncture Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
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
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
Estimated Study Start Date : August 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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.

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"
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582423


Contacts
Contact: Linda Zhong, MD., Ph.D 852-34116523 ldzhong0305@gmail.com

Sponsors and Collaborators
Hong Kong Baptist University
Princess Margaret Hospital, Hong Kong
Investigators
Study Director: Bacon Ng, Ph.D Department of Chinese Medicine, Hospital Authority

Responsible Party: Zhong Lidan, Research Assistant Professor, Hong Kong Baptist University
ClinicalTrials.gov Identifier: NCT03582423     History of Changes
Other Study ID Numbers: HKBU-YCH
First Posted: July 11, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents