Back to resultsEfficacy of Acupuncture on Chemotherapy-Induced Peripheral Neuropathy
Primary Purpose
Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
acupuncture
minimal acupuncture
Sponsored by
About this trial
This is an interventional treatment trial for Chemotherapy-Induced Peripheral Neuropathy (CIPN) focused on measuring acupuncture, chemotherapy-induced peripheral neuropathy, neuropathic pain, von-Frey monofilament test, taxane, platinum
Eligibility Criteria
Inclusion criteria:
The study will enroll patients with a symptom of peripheral neuropathy, including paresthesia, numbness, glove-and-stocking sensory loss distribution or pain in four limbs, and meet the following inclusion criteria:
- All adult cancer patients (Age≧20-year-old) who received chemotherapy regimens, including adjuvant and neoadjuvant therapy
- Stage I-III cancer patients
- Completed chemotherapy regimens more than3 months, including Taxanes (paclitaxel or docetaxel), platinum (cisplatin, oxaliplatin, carboplatin)
- Baseline von Frey Monofilament test (Target force at hand) ≧ 0.07gms
- Baseline von Frey Monofilament test (Target force at foot) ≧ 0.4gms
- Eastern Cooperative Oncology Group (ECOG) performance status ≦3
- Grading of peripheral sensory neuropathy in National Cancer Institute- common terminology criteria for adverse events,v5.0 (NCI-CTCAE5) ≧1
- Patients were restricted acupuncture treatment for one month before recruitment
- Written patient informed consent
Exclusion criteria:
Participants with any of the following conditions will be excluded:
- Uncontrolled Diabetic Mellitus, HbA1c≧7% is inappropriate[19].
- Diabetic neuropathy diagnosed before receiving chemotherapy
- Neuropathy from any type of nerve compression (e.g., carpal/tarsal tunnel syndrome, radiculopathy, spinal stenosis, brachial plexopathy)
- Concomitant with duloxetine, or another analgesia, including Pregabalin, Venlafaxine, Minocycline, Topical gel, Oxycodone, Naloxone, Cannabinoids, and Angiotensin II type 2 receptor antagonist
- Severe hemorrhagic coagulopathy or bleeding tendency
- Unstable cardiovascular disease
- Severe skin lesions around the treatment sites The researchers will exclude any participants considered to be inappropriate for the study.
Sites / Locations
- Taipei Veterans General HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
No Intervention
Arm Label
acupuncture group
sham-controlled group
waitlist-control group
Arm Description
The acupuncture group and the sham-controlled group will receive three therapeutic sessions each week for four weeks, and another two sessions each week for four weeks (a total of 20 sessions at eight weeks). Each group will be followed-up for four weeks, to evaluate the persistent efficacy of acupuncture.The needle set for the sham acupuncture group and the real acupuncture group will use the CASOON Acupuncture Needle (Wuxi Jiajian Medical Instrument Company, limited), which needle size is 0.3 mm×30 mm. The depth of needling varied based on the patient's body sizes. After insertion, the needles were manually manipulated to obtain the De Qi sensation, which was defined as the acupuncturist feeling a tugging or grasping sensation from the needle manipulation and the patient feeling soreness, fullness, heaviness, or local distension at local needling sites.
The sham acupuncture group will be performed by superficial needling with less than 4mm depth. The needling location is about 0.5 cm away from the acupoints. Both the real acupuncture group and the sham acupuncture group received the same treatment protocol.
As an waitlist-control group, no acupuncture will be performed.
Outcomes
Primary Outcome Measures
FACT-Neurotoxicity subscale(NtxS)
The primary outcome will be the change FACT-Neurotoxicity subscale(NtxS) from baseline to 20 sessions at 8th weeks. The neurotoxicity subscale from the FACT/GOG-NTX-13(version 4) contains 13 items assessing numbness, tingling, and discomfort in the hands or feet, difficulty hearing, tinnitus, joint pain or muscle cramps, weakness, or trouble walking, buttoning buttons, or feeling small shapes when placed in the hand. Items are scored from 0-4 (0 = not at all; 4 = very much) and summed (total score range = 0-52). Since no published data are defining a cut-point for determining a clinically important change in the FACT/GOG Ntx score, we defined a 4 point change as a clinically meaningful improvement in patient-reported CIPN-related neurotoxicity outcome . The authorized translated traditional Chinese version will be purchased in this study.
Secondary Outcome Measures
The change of BPI-SF
Our secondary outcome will be the change of average pain severity in BPI-SF from baseline to 20 sessions at 8th weeks. BPI-SF is an instrument used to evaluate the severity of pain, including neuropathic pain and the interference on the patients' daily functioning. Items are scored from 0 to 10 (0= no pain; 10= pain as bad as you can imagine). Since not all the patients feel pain in their daily life, we selected the participants who have average pain severity more than 4 points at baseline assessment into the final analysis. The authorized translated traditional Chinese version will be purchased in this study.
The quantitative sensation of touch detection
The quantitative sensation of touch detection was used to test sensory levels and obtain objective data on the status of diminishing or returning sensibility. Touch detection was measured using von Frey monofilaments (Semmes-Weinstein Von Frey Aesthesiometer, Stoelting Co. 620 Wheat Lane, Wood Dale, IL, USA), with weights from 0.008 g to 300 g at 8 points. The measuring sites including the bases of the sole, tips of the big toe, palmar sides of hands, and the fingertips of the middle finger. The well-known up-down method applied to measure touch-detection thresholds.
It will be assessed before the first intervention in the first week, after the 20th intervention in the 8th week, and the follow-up assessment in the end of the 12th week. Each intervention is one day. Each von-Frey test or questionnaire will be performed within seven days from each time point.
Full Information
NCT ID
NCT04739631
First Posted
January 8, 2021
Last Updated
April 26, 2021
Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
China Medical University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04739631
Brief Title
Efficacy of Acupuncture on Chemotherapy-Induced Peripheral Neuropathy
Official Title
Efficacy of Acupuncture on Chemotherapy-Induced Peripheral Neuropathy (CIPN): A Phase III, Randomized, Sham-controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 22, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Veterans General Hospital, Taiwan
Collaborators
China Medical University Hospital
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
The purpose of this study is to assess the neurological efficacy of acupuncture in patients with cancer who experienced peripheral neuropathy, which is induced by chemotherapy.
Detailed Description
Background: Chemotherapy may lead to peripheral neuropathy up to 40% in cancer survivors, especially in some types of patients with cancer. The effect of acupuncture, an ancient Chinese medicine technique, was recognized by the World Health Organization (WHO) in the treatment of several diseases. The postulated mechanisms associated with acupuncture in analgesia or neurogenesis are still under investigation. Considering a moderate recommendation for duloxetine in the treatment of chemotherapy-induced peripheral neuropathy (CIPN) based on based on neuropathic pain, and a few treatment options with evidence for CIPN, acupuncture might be another option. Nowadays, only small scale pilot studies provided initial proof of acupuncture in CIPN, particularly in decreasing neuropathic pain and improving neurotoxicity, the study aims to determine the beneficial effects of acupuncture on CIPN with a large-scale, multicenter, randomized sham-controlled clinical trial. Furthermore, the aim of the study will provide evidence for the clinical therapeutic guideline of CIPN in the future.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-Induced Peripheral Neuropathy (CIPN)
Keywords
acupuncture, chemotherapy-induced peripheral neuropathy, neuropathic pain, von-Frey monofilament test, taxane, platinum
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
94 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
acupuncture group
Arm Type
Experimental
Arm Description
The acupuncture group and the sham-controlled group will receive three therapeutic sessions each week for four weeks, and another two sessions each week for four weeks (a total of 20 sessions at eight weeks). Each group will be followed-up for four weeks, to evaluate the persistent efficacy of acupuncture.The needle set for the sham acupuncture group and the real acupuncture group will use the CASOON Acupuncture Needle (Wuxi Jiajian Medical Instrument Company, limited), which needle size is 0.3 mm×30 mm. The depth of needling varied based on the patient's body sizes. After insertion, the needles were manually manipulated to obtain the De Qi sensation, which was defined as the acupuncturist feeling a tugging or grasping sensation from the needle manipulation and the patient feeling soreness, fullness, heaviness, or local distension at local needling sites.
Arm Title
sham-controlled group
Arm Type
Placebo Comparator
Arm Description
The sham acupuncture group will be performed by superficial needling with less than 4mm depth. The needling location is about 0.5 cm away from the acupoints. Both the real acupuncture group and the sham acupuncture group received the same treatment protocol.
Arm Title
waitlist-control group
Arm Type
No Intervention
Arm Description
As an waitlist-control group, no acupuncture will be performed.
Intervention Type
Other
Intervention Name(s)
acupuncture
Intervention Description
use disposable sterile needles to insert to the acupuncture point
Intervention Type
Other
Intervention Name(s)
minimal acupuncture
Intervention Description
The sham-controlled group will be performed with minimal acupuncture(superficial needling) at non- acupoints.
Primary Outcome Measure Information:
Title
FACT-Neurotoxicity subscale(NtxS)
Description
The primary outcome will be the change FACT-Neurotoxicity subscale(NtxS) from baseline to 20 sessions at 8th weeks. The neurotoxicity subscale from the FACT/GOG-NTX-13(version 4) contains 13 items assessing numbness, tingling, and discomfort in the hands or feet, difficulty hearing, tinnitus, joint pain or muscle cramps, weakness, or trouble walking, buttoning buttons, or feeling small shapes when placed in the hand. Items are scored from 0-4 (0 = not at all; 4 = very much) and summed (total score range = 0-52). Since no published data are defining a cut-point for determining a clinically important change in the FACT/GOG Ntx score, we defined a 4 point change as a clinically meaningful improvement in patient-reported CIPN-related neurotoxicity outcome . The authorized translated traditional Chinese version will be purchased in this study.
Time Frame
It will be assessed before the first intervention in the first week, after the 12th intervention in the 4th week , after the 20th intervention in the 8th week, and the follow-up assessment in the end of the 12th week. Each intervention is one day.
Secondary Outcome Measure Information:
Title
The change of BPI-SF
Description
Our secondary outcome will be the change of average pain severity in BPI-SF from baseline to 20 sessions at 8th weeks. BPI-SF is an instrument used to evaluate the severity of pain, including neuropathic pain and the interference on the patients' daily functioning. Items are scored from 0 to 10 (0= no pain; 10= pain as bad as you can imagine). Since not all the patients feel pain in their daily life, we selected the participants who have average pain severity more than 4 points at baseline assessment into the final analysis. The authorized translated traditional Chinese version will be purchased in this study.
Time Frame
It will be assessed before the first intervention in the first week, after the 12th intervention in the 4th week , after the 20th intervention in the 8th week, and the follow-up assessment in the end of the 12th week. Each intervention is one day.
Title
The quantitative sensation of touch detection
Description
The quantitative sensation of touch detection was used to test sensory levels and obtain objective data on the status of diminishing or returning sensibility. Touch detection was measured using von Frey monofilaments (Semmes-Weinstein Von Frey Aesthesiometer, Stoelting Co. 620 Wheat Lane, Wood Dale, IL, USA), with weights from 0.008 g to 300 g at 8 points. The measuring sites including the bases of the sole, tips of the big toe, palmar sides of hands, and the fingertips of the middle finger. The well-known up-down method applied to measure touch-detection thresholds.
It will be assessed before the first intervention in the first week, after the 20th intervention in the 8th week, and the follow-up assessment in the end of the 12th week. Each intervention is one day. Each von-Frey test or questionnaire will be performed within seven days from each time point.
Time Frame
It will be assessed before the first intervention in the first week, after the 20th intervention in the 8th week, and the follow-up assessment in the end of the 12th week. Each intervention is one day.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
The study will enroll patients with a symptom of peripheral neuropathy, including paresthesia, numbness, glove-and-stocking sensory loss distribution or pain in four limbs, and meet the following inclusion criteria:
All adult cancer patients (Age≧20-year-old) who received chemotherapy regimens, including adjuvant and neoadjuvant therapy
Stage I-III cancer patients
Completed chemotherapy regimens more than3 months, including Taxanes (paclitaxel or docetaxel), platinum (cisplatin, oxaliplatin, carboplatin)
Baseline von Frey Monofilament test (Target force at hand) ≧ 0.07gms
Baseline von Frey Monofilament test (Target force at foot) ≧ 0.4gms
Eastern Cooperative Oncology Group (ECOG) performance status ≦3
Grading of peripheral sensory neuropathy in National Cancer Institute- common terminology criteria for adverse events,v5.0 (NCI-CTCAE5) ≧1
Patients were restricted acupuncture treatment for one month before recruitment
Written patient informed consent
Exclusion criteria:
Participants with any of the following conditions will be excluded:
Uncontrolled Diabetic Mellitus, HbA1c≧7% is inappropriate[19].
Diabetic neuropathy diagnosed before receiving chemotherapy
Neuropathy from any type of nerve compression (e.g., carpal/tarsal tunnel syndrome, radiculopathy, spinal stenosis, brachial plexopathy)
Concomitant with duloxetine, or another analgesia, including Pregabalin, Venlafaxine, Minocycline, Topical gel, Oxycodone, Naloxone, Cannabinoids, and Angiotensin II type 2 receptor antagonist
Severe hemorrhagic coagulopathy or bleeding tendency
Unstable cardiovascular disease
Severe skin lesions around the treatment sites The researchers will exclude any participants considered to be inappropriate for the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fang-Pey Chen, Ph.D
Phone
886-2-28757453
Email
fpchen@vghtpe.gov.tw
Facility Information:
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Acupuncture on Chemotherapy-Induced Peripheral Neuropathy
We'll reach out to this number within 24 hrs