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Completed

NCT Number: NCT03582423

Acupuncture for Chemotherapy-induced Peripheral Neuropathy

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.

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Key information

Conditions

Chemotherapy Induced Peripheral Neuropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linda Zhong

Kowloon Tong, Kowloon, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hong Kong Baptist University

Other

Collaborators

  • Princess Margaret Hospital, Hong Kong

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 11, 2018
Registry last updated
Oct 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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