Chemotherapy-Induced Peripheral Neuropathy (CIPN)NCT04739631
Efficacy of Acupuncture on Chemotherapy-Induced Peripheral Neuropathy
A study testing acupuncture and minimal acupuncture in people with Chemotherapy-Induced Peripheral Neuropathy (CIPN), run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Chemotherapy-Induced Peripheral Neuropathy (CIPN)
- What is being tested?
- acupuncture and minimal acupuncture
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Jan 2021to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Acupuncture on Chemotherapy-Induced Peripheral Neuropathy (CIPN): A Phase III, Randomized, Sham-controlled Clinical Trial
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.
Read the 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.
- Being tested
- acupuncture, minimal acupuncture
- Keywords
- acupuncture, chemotherapy-induced peripheral neuropathy, neuropathic pain, von-Frey monofilament test, taxane, platinum
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
acupunctureOther
use disposable sterile needles to insert to the acupuncture point
minimal acupunctureOther
The sham-controlled group will be performed with minimal acupuncture(superficial needling) at non- acupoints.
| Study group | Role | What they receive |
|---|---|---|
| acupuncture group | Experimental | 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. Receives: Other: acupuncture |
| sham-controlled group | Placebo comparator | 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. Receives: Other: minimal acupuncture |
| waitlist-control group | No intervention | As an waitlist-control group, no acupuncture will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (2)
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.
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start22 Jan 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy-Induced Peripheral Neuropathy (CIPN)Studies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Collaborators
- China Medical University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04739631
- Sponsor's protocol ID
- 2020-09-005C
- Status last verified
- Apr 2021
- First submitted
- 8 Jan 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Acupuncture on Chemotherapy-Induced Peripheral Neuropathy (CIPN): A Phase III, Randomized, Sham-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04739631
- Acronym / sponsor ID
- 2020-09-005C
- Keywords
- acupuncture, chemotherapy-induced peripheral neuropathy, neuropathic pain, von-Frey monofilament test, taxane, platinum
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 94 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Collaborators
- China Medical University Hospital
- Study start
- 22 Jan 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| acupuncture group | Experimental | Other: acupunctureThe 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. |
| sham-controlled group | Placebo comparator | Other: minimal acupunctureThe 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. |
| waitlist-control group | No intervention | –As an waitlist-control group, no acupuncture will be performed. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| acupunctureuse disposable sterile needles to insert to the acupuncture point | Other | acupuncture group |
| minimal acupunctureThe sham-controlled group will be performed with minimal acupuncture(superficial needling) at non- acupoints. | Other | sham-controlled group |
Primary outcome
FACT-Neurotoxicity subscale(NtxS)
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.
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.
2 secondary outcomes
The change of BPI-SF
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.
The quantitative sensation of touch detection
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing acupuncture and minimal acupuncture in people with Chemotherapy-Induced Peripheral Neuropathy (CIPN), run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fang-Pey Chen, Ph.D (886-2-28757453, fpchen@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FACT-Neurotoxicity subscale(NtxS) (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.