Back to resultsElectro-acupuncture for the Prevention and Treatment of Oxaliplatin-induced Neurotoxicity in Colorectal Cancer Patients
Primary Purpose
Colorectal Cancer, Oxaliplatin, Electro-acupuncture
Status
Not yet recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Acupuncture
Sham-acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Colorectal Cancer
Eligibility Criteria
Inclusion Criteria: are aged ≥18 years old; are newly diagnosed with stage II to IV colorectal cancer; going to receive adjuvant oxaliplatin-based chemotherapy within 4 weeks; had not received any acupuncture in the previous 3 months and had a life expectancy ≥ of six months. Exclusion Criteria: are not able to comprehend and communicate; are not able to read Chinese; have prior peripheral neuropathy caused by other diseases including diabetes, stroke, cardiovascular diseases such as arrhythmia, heart failure, myocardial infarction, and patients with cardiac pacemakers; have a bleeding tendency; are pregnant or breastfeeding; have impaired hepatic or renal function; using any pharmaceutical agents e.g., vitamin B6 and vitamin E, or herbal medication. All the above medication prescribed by physicians or Chinese medicine practitioners during the study will be recorded.
Sites / Locations
- Linda Zhong
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Electro-acupuncture group
sham-acupuncture group
Arm Description
The electro-acupuncture intervention will be conducted for 2 sessions per week for 4 consecutive weeks before and 8 weeks during the chemotherapy. In this study 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 occur due to Capecitabine (Xeloda). Disposable acupuncture needles (verum acupuncture needles Hwato 0.25 x 25mm matching the Streiterger sham needles) will be inserted at a depth of 10-25mm into the points. Electrical stimulation will be delivered with continuous waves at 2 Hz, at an intensity of each patient's minimum sensation of stimulation through the electrical acupuncture stimulation instrument. The needles will be retained in position for 25 minutes.
For subjects assigned to the sham control group, Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2"/ 0.30 x 30mm) will be applied to serve as a sham control at the same acupoints with the same stimulation modality, and the stimulation will be a "pseudo stimulation", which will be given by connecting the needle to the incorrect output socket of the electrical acupuncture stimulation instrument.The credibility and validity of this system have been well demonstrated.
Outcomes
Primary Outcome Measures
Score Changes on the FACT/GOG-Ntx questionnaire
The questionnaire includes 11 questions covering sensory neuropathy, motor neuropathy, hearing neuropathy, and dysfunction associated with neuropathy, which results in a cumulative score ranging from 0 to 44, with the lower scores reflecting worse neuropathy symptoms.
Secondary Outcome Measures
numerical rating scale (NRS)
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 neuropathy while ≥4 of 10 NRS will be considered as moderate to severe neuropathy.
European Organization for Research and Treatment of Cancer (EORCTC) quality of life questionnaire QLQ-C30
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 (dyspnoea, appetite loss, insomnia, constipation, diarrhoea, and financial difficulties).
Constitution of Chinese Medicine Questionnaire (CCMQ)
CCMQ 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.
Vibration sense test
It will be assessed using the graduated Rydel-Seiffer tuning fork (U.S. Neurologicals, Poulsbo, WA), with printed directions for use and its normative data. Readings will be averaged and recorded as the vibration value.
Light touch test
It will be assessed with standard 10g monofilaments, contained within the Neuropen (Owen Mumford, Woodstock, UK). During testing, the fiber will be applied perpendicular to the plantar surface of the great toe and the palmar surface of the index finger until the fiber begins to bend and will be held in place for 1 second and then removed. This procedure will be repeated 3 times and the patient will be asked to report the ability to feel the fibe.
Short Form 12 item(version 2) Health Survey (SF-12V2)
The SF-12V2 is a widely used generic HRQoL instrument, and its Chinese version has been validated and normed in the general Chinese population in Hong Kong. It consists of 12 questions measuring eight domains of health, including physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The scores are generated using an algorithm to generate a combined physical and mental health score for comparison with normative data. In the normative data: 1) the mean score was set to 50; 2) a score > 50 indicated better physical or mental health than the mean; 3) a score < 50 indicated worse physical or mental health than the mean.
Full Information
NCT ID
NCT05798884
First Posted
March 9, 2023
Last Updated
April 3, 2023
Sponsor
Hong Kong Baptist University
Collaborators
Princess Margaret Hospital, Hong Kong, Queen Mary Hospital, Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05798884
Brief Title
Electro-acupuncture for the Prevention and Treatment of Oxaliplatin-induced Neurotoxicity in Colorectal Cancer Patients
Official Title
Electro-acupuncture for the Prevention and Treatment of Oxaliplatin-induced Neurotoxicity in Colorectal Cancer Patients: a Prospective, Randomized, Sham-controlled, Double-blinded and Multicenter Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
April 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hong Kong Baptist University
Collaborators
Princess Margaret Hospital, Hong Kong, Queen Mary 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 randomized, sham-controlled, single-blind, multicenter clinical trial will be conducted to explore the effect of electroacupuncture for prevention and treatment of both acute and chronic neurotoxicity through both clinical and biological indicators.
Detailed Description
This is a prospective, randomized, sham-controlled, double-blinded and multiple center trial on electro-acupuncture for preventing and treating symptoms of chemotherapy-induced neurotoxicity in patients with colorectal cancer. A total of 150 candidates will be recruited in this study four weeks before chemotherapy for best preventive effect. They will be assigned randomly into either the electro-acupuncture or the sham-control group with 1:1 ratio. Both groups will receive a total of 24 sessions of interventions (4 weeks before chemotherapy and 8 weeks during chemotherapy, with 2 session per week), and will be followed up regularly for up to 12 weeks after completion of the acupuncture.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Oxaliplatin, Electro-acupuncture, Neurotoxicity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
All patients and the investigators including the research assessors, the statistician, and the researchers interacting with the patients except the one who conducts the acupuncture therapy will be blinded.
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Electro-acupuncture group
Arm Type
Experimental
Arm Description
The electro-acupuncture intervention will be conducted for 2 sessions per week for 4 consecutive weeks before and 8 weeks during the chemotherapy. In this study 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 occur due to Capecitabine (Xeloda). Disposable acupuncture needles (verum acupuncture needles Hwato 0.25 x 25mm matching the Streiterger sham needles) will be inserted at a depth of 10-25mm into the points. Electrical stimulation will be delivered with continuous waves at 2 Hz, at an intensity of each patient's minimum sensation of stimulation through the electrical acupuncture stimulation instrument. The needles will be retained in position for 25 minutes.
Arm Title
sham-acupuncture group
Arm Type
Sham Comparator
Arm Description
For subjects assigned to the sham control group, Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2"/ 0.30 x 30mm) will be applied to serve as a sham control at the same acupoints with the same stimulation modality, and the stimulation will be a "pseudo stimulation", which will be given by connecting the needle to the incorrect output socket of the electrical acupuncture stimulation instrument.The credibility and validity of this system have been well demonstrated.
Intervention Type
Device
Intervention Name(s)
Acupuncture
Intervention Description
Disposable acupuncture needles (0.25 mm in diameter and 25 mm in length) are straightly into body acupuncture points (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 occur due to Capecitabine (Xeloda). Electrical stimulation will be delivered with continuous waves at 2 Hz, at an intensity of each patient's minimum sensation of stimulation through the electrical acupuncture stimulation instrument. The needles will be retained in position for 25 minutes.
Intervention Type
Device
Intervention Name(s)
Sham-acupuncture
Intervention Description
Streitberger's non-invasive acupuncture needles (Gauge 8 x 1.2"/ 0.30 x 30mm) will be applied to serve as a sham control at the same acupoints with the same stimulation modality and then connecting the needle to the incorrect output socket of the electrical acupuncture stimulation instrument. The sham points are "pseudo stimulation".
Primary Outcome Measure Information:
Title
Score Changes on the FACT/GOG-Ntx questionnaire
Description
The questionnaire includes 11 questions covering sensory neuropathy, motor neuropathy, hearing neuropathy, and dysfunction associated with neuropathy, which results in a cumulative score ranging from 0 to 44, with the lower scores reflecting worse neuropathy symptoms.
Time Frame
0-24 weeks; weekly
Secondary Outcome Measure Information:
Title
numerical rating scale (NRS)
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 neuropathy while ≥4 of 10 NRS will be considered as moderate to severe neuropathy.
Time Frame
0-24 weeks; weekly
Title
European Organization for Research and Treatment of Cancer (EORCTC) quality of life questionnaire QLQ-C30
Description
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 (dyspnoea, appetite loss, insomnia, constipation, diarrhoea, and financial difficulties).
Time Frame
0,3,6,9,12,15,18,21,24 weeks
Title
Constitution of Chinese Medicine Questionnaire (CCMQ)
Description
CCMQ 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.
Time Frame
0,12,24 weeks
Title
Vibration sense test
Description
It will be assessed using the graduated Rydel-Seiffer tuning fork (U.S. Neurologicals, Poulsbo, WA), with printed directions for use and its normative data. Readings will be averaged and recorded as the vibration value.
Time Frame
0-12 week; weekly
Title
Light touch test
Description
It will be assessed with standard 10g monofilaments, contained within the Neuropen (Owen Mumford, Woodstock, UK). During testing, the fiber will be applied perpendicular to the plantar surface of the great toe and the palmar surface of the index finger until the fiber begins to bend and will be held in place for 1 second and then removed. This procedure will be repeated 3 times and the patient will be asked to report the ability to feel the fibe.
Time Frame
0-12 week; weekly
Title
Short Form 12 item(version 2) Health Survey (SF-12V2)
Description
The SF-12V2 is a widely used generic HRQoL instrument, and its Chinese version has been validated and normed in the general Chinese population in Hong Kong. It consists of 12 questions measuring eight domains of health, including physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional and mental health. The scores are generated using an algorithm to generate a combined physical and mental health score for comparison with normative data. In the normative data: 1) the mean score was set to 50; 2) a score > 50 indicated better physical or mental health than the mean; 3) a score < 50 indicated worse physical or mental health than the mean.
Time Frame
0-12 week; weekly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
are aged ≥18 years old;
are newly diagnosed with stage II to IV colorectal cancer;
going to receive adjuvant oxaliplatin-based chemotherapy within 4 weeks;
had not received any acupuncture in the previous 3 months and had a life expectancy ≥ of six months.
Exclusion Criteria:
are not able to comprehend and communicate;
are not able to read Chinese;
have prior peripheral neuropathy caused by other diseases including diabetes, stroke, cardiovascular diseases such as arrhythmia, heart failure, myocardial infarction, and patients with cardiac pacemakers;
have a bleeding tendency;
are pregnant or breastfeeding;
have impaired hepatic or renal function;
using any pharmaceutical agents e.g., vitamin B6 and vitamin E, or herbal medication. All the above medication prescribed by physicians or Chinese medicine practitioners during the study will be recorded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Linda Zhong
Phone
852-34116523
Email
ldzhong0305@gmail.com
Facility Information:
Facility Name
Linda Zhong
City
Kowloon Tong
State/Province
Kowloon
Country
Hong Kong
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Links:
URL
https://www3.ha.org.hk/cancereg/
Description
accessed on 29 March 2021
Learn more about this trial
Electro-acupuncture for the Prevention and Treatment of Oxaliplatin-induced Neurotoxicity in Colorectal Cancer Patients
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