Chemotherapy Induced Peripheral Neuropathy (CIPN)NCT07279818
Improving Chemotherapy Induced Peripheral Neuropathy in Children With Leukemia: A Study of Transcutaneous Acupoints Electrical Stimulation and Auricular Acupressure Interventions
A study testing Transcutaneous Acupoints Electrical Stimulation (TAES) and Auricular Acupressure (AA) in people with Chemotherapy Induced Peripheral Neuropathy (CIPN), run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
The goal of this clinical trial is to compare the effectiveness of Transcutaneous Acupoints Electrical Stimulation (TAES) and Auricular Acupressure (AA) on subject CIPN symptoms, sensory function, motor and physical function, psychological, physical symptoms and quality of life outcomes in Children with Leukemia. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Chemotherapy Induced Peripheral Neuropathy (CIPN)
- What is being tested?
- Transcutaneous Acupoints Electrical Stimulation (TAES) and Auricular Acupressure (AA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 132 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age between 8 and 17 years old
- diagnosed with leukemia
- received neurotoxic chemotherapy
- have developed score 9 or above CIPN symptoms according to Pediatric Chemotherapy-Induced Neuropathy (P-CIN)
- able to communicate and read Chinese
Who cannot join
- receiving multiple cancer treatment
- had a diagnosis of cancer in the central nervous system cancer, cancer relapse or secondary cancer
- having other neuromuscular disorders, for example, traumatic brain injury and cerebral palsy
- having other systematic diseases that cause toxicity in the peripheral nervous system, such as sickle cell disease (SCD), Guillain-Barre ́ Syndrome (GBS), anterior cutaneous nerve entrapment syndrome (ACNES), obstetric brachial plexus injury (OBPI), type I diabetes mellitus, postherpetic neuralgia (PHN), peroneal nerve injury, and reflex sympathetic dystrophy (RSD)
- acupoints areas with injuries, wounds or allodynia
- participated in any other CIPN non-pharmacological intervention programme
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- having any impaired bone marrow suppression, liver or renal function
- contraindications to TEAS or auricular acupressure: such as having a pacemaker, skin infection, damage, or allergy to the electrodes
- suffering from mental illness or using antipsychotic drugs
- parents and children refused to give consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shanghai Children Medical Center
Shanghai
Meng Xue He, PhD, (86)15702140512, hemx0321@163.com
About this study
Official title: Effectiveness of Transcutaneous Acupoints Electrical Stimulation and Auricular Acupressure on Chemotherapy Induced Peripheral Neuropathy in Children With Leukemia: a Single Blind Randomized Controlled Study
The goal of this clinical trial is to compare the effectiveness of Transcutaneous Acupoints Electrical Stimulation (TAES) and Auricular Acupressure (AA) on subject CIPN symptoms, sensory function, motor and physical function, psychological, physical symptoms and quality of life outcomes in Children with Leukemia.
The main questions it aims to answer are:
Read more
- Does TAES and AA can improve CIPN symptoms, sensory function, motor and physical function, psychological, physical symptoms and quality of life outcomes in children with Leukemia compared with self-management control group?
- Does TAES yield improvements in CIPN symptoms, sensory function, motor and physical function, psychological, physical symptoms and quality of life outcomes that are comparable to those achieved through AA in children with leukemia?
This proposed research is designed to conduct a three-arm RCT comparing TAES, AA to usual care in children with leukemia.
Subjects in TAES group will receive 8 weeks TAES on four acupoints. Subjects in AA group will receive 8 weeks on four acupoints. Subjects in self-management control group will receive usual care they will receive from the hospital. These three groups will be provided with a leaflet containing self-help materials for CIPN.
- Being tested
- Transcutaneous Acupoints Electrical Stimulation (TAES), Auricular Acupressure (AA), No intervention
- Keywords
- Transcutaneous Acupoints Electrical Stimulation, Auricular Acupressure, chemotherapy induced peripheral neuropathy, Leukemia, children
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Acupoints Electrical Stimulation (TAES)Behavioural
Transcutaneous Acupoints Electrical Stimulation (TAES) is a kind of physical therapy that use electric current through the electrodes placed on the surface of acupoints to produce clinical effects in the human body.
Auricular Acupressure (AA)Behavioural
Auricular acupressure (AA) is a non-invasive therapy rooted in Traditional Chinese Medicine (TCM) that involves applying pressure to specific acupoints on the ear using Vaccaria seeds.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Acupoints Electrical Stimulation (TAES) | Experimental | The intervention for TAES group will last 8 weeks, conducting 2 times per week, total covering 16 sessions. The intervention will be delivered a registered nurse with qualified TCM nurse certification. Four bilateral acupoints - Hegu, Shousanli , Zusanli, and Chongyang will be choosen. TAES will be deliveried by electronic acupunture treatment instrument with low frequency. Each session is 60 minutes. Receives: Behavioral: Transcutaneous Acupoints Electrical Stimulation (TAES) |
| Auricular Acupressure (AA) | Experimental | The AA subjects received auricular acupressure three times a day for two days every week for 8 weeks, total covering 16 sessions. Four acupoints including Shenmen (TF4), sympathetic (AH6a), fingers (SF1) and toes (AH2) will be choosen. A small piece of adhesive tape with vaccaria seed will be taped onto each selected auricular acupoint on a subject's ear. Receives: Behavioral: Auricular Acupressure (AA) |
| Self-Managed control group | Placebo comparator | Subjects shall receive leaflet containing self-help materials for CIPN which they can conduct by themself (self-management) and continue to receive their usual care from the hospital. Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
CIPN severity - Pediatric Chemotherapy-Induced Neuropathy (P-CIN)
To evaluate the severity of CIPN. The Pediatric Chemotherapy-Induced Neuropathy scale contains 13 items, with eight items to rate CIPN symptoms in the hands and feet and five items to rate the difficulty of performing functional tasks. The total score ranges from 0 to 65 with higher scores indicating more severe CIPN.
Measured: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Secondary outcomes (8)
Sensory function outcomes
Touch sensation were measured using monofilament examination with the best of both 2 trials on each side averaged.
Measured: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Sensory function outcomes
Vibration sensation were measured using a 128 Hz tuning fork, with the best of both 2 trials on each side averaged.
Measured: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Motor and physical function
Timed Up and Go test (TUG) will be used to evaluate the motor and physical function in children with leukemia.
Measured: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Motor and physical function
30-second sitting-rising test will be used to evaluate the motor and physical function in children with leukemia.
Measured: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Motor and physical function
Handheld grip strength meter will be used to evaluate the motor and physical function in children with leukemia.
Measured: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Psychological distress
National Comprehensive Cancer Network (NCCN) distress thermometer will be used to evaluate the psychological distress of children with leukemia. It included two parts: one is a single-item DT screening tool using an 11-point visual scale for respondents to rate their level of subjective distress from 0 (no distress) to 10 (extreme distress). A cut off value ≥4 was recommended to indicate a distressed patient; another is a 40-items problem list to identify potential sources of distress including practical, family, emotional, physical, and spiritual distress.
Measured: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Physical symptoms
The therapy-related symptom checklist for children (TRSC-C) Chinese version will be used to assess the physical symptoms severity. The total TRSC-C score ranges between 0 to 120, with higher scores indicating greater severity of symptoms.
Measured: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Quality of life outcome
Pediatric Quality of Life Inventory version 3.0 cancer module (PedsQL 3.0 cancer module) will be used to evalute the quality of life for children with leukemia. The scale score was the average of the total item scores, with higher scores representing better quality of life.
Measured: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study start8 Dec 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (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 The Hong Kong Polytechnic UniversityThe 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
- Investigator, Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Children's Medical Center
- Responsible party
- Principal investigator, Dr Eva Ho, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279818
- Sponsor's protocol ID
- TAES and AA to treat CIPN
- Status last verified
- Dec 2025
- First submitted
- 22 Nov 2025
- Last updated
- 12 Dec 2025
- 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 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Transcutaneous Acupoints Electrical Stimulation and Auricular Acupressure on Chemotherapy Induced Peripheral Neuropathy in Children With Leukemia: a Single Blind Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07279818
- Acronym / sponsor ID
- TAES and AA to treat CIPN
- Keywords
- Transcutaneous Acupoints Electrical Stimulation, Auricular Acupressure, chemotherapy induced peripheral neuropathy, Leukemia, children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 132 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Shanghai Children's Medical Center
- Study start
- 8 Dec 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 12 Dec 2025 (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 goal of this clinical trial is to compare the effectiveness of Transcutaneous Acupoints Electrical Stimulation (TAES) and Auricular Acupressure (AA) on subject CIPN symptoms, sensory function, motor and physical function, psychological, physical symptoms and quality of life outcomes in Children with Leukemia.
The main questions it aims to answer are:
- Does TAES and AA can improve CIPN symptoms, sensory function, motor and physical function, psychological, physical symptoms and quality of life outcomes in children with Leukemia compared with self-management control group?
- Does TAES yield improvements in CIPN symptoms, sensory function, motor and physical function, psychological, physical symptoms and quality of life outcomes that are comparable to those achieved through AA in children with leukemia?
This proposed research is designed to conduct a three-arm RCT comparing TAES, AA to usual care in children with leukemia.
Subjects in TAES group will receive 8 weeks TAES on four acupoints. Subjects in AA group will receive 8 weeks on four acupoints. Subjects in self-management control group will receive usual care they will receive from the hospital. These three groups will be provided with a leaflet containing self-help materials for CIPN.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Acupoints Electrical Stimulation (TAES) | Experimental | Behavioral: Transcutaneous Acupoints Electrical Stimulation (TAES)The intervention for TAES group will last 8 weeks, conducting 2 times per week, total covering 16 sessions. The intervention will be delivered a registered nurse with qualified TCM nurse certification. Four bilateral acupoints - Hegu, Shousanli , Zusanli, and Chongyang will be choosen. TAES will be deliveried by electronic acupunture treatment instrument with low frequency. Each session is 60 minutes. |
| Auricular Acupressure (AA) | Experimental | Behavioral: Auricular Acupressure (AA)The AA subjects received auricular acupressure three times a day for two days every week for 8 weeks, total covering 16 sessions. Four acupoints including Shenmen (TF4), sympathetic (AH6a), fingers (SF1) and toes (AH2) will be choosen. A small piece of adhesive tape with vaccaria seed will be taped onto each selected auricular acupoint on a subject's ear. |
| Self-Managed control group | Placebo comparator | Other: No interventionSubjects shall receive leaflet containing self-help materials for CIPN which they can conduct by themself (self-management) and continue to receive their usual care from the hospital. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- age between 8 and 17 years old
- diagnosed with leukemia
- received neurotoxic chemotherapy
- have developed score 9 or above CIPN symptoms according to Pediatric Chemotherapy-Induced Neuropathy (P-CIN)
- able to communicate and read Chinese
Key exclusion criteria (10 listed)
- receiving multiple cancer treatment
- had a diagnosis of cancer in the central nervous system cancer, cancer relapse or secondary cancer
- having other neuromuscular disorders, for example, traumatic brain injury and cerebral palsy
- having other systematic diseases that cause toxicity in the peripheral nervous system, such as sickle cell disease (SCD), Guillain-Barre ́ Syndrome (GBS), anterior cutaneous nerve entrapment syndrome (ACNES), obstetric brachial plexus injury (OBPI), type I diabetes mellitus, postherpetic neuralgia (PHN), peroneal nerve injury, and reflex sympathetic dystrophy (RSD)
- acupoints areas with injuries, wounds or allodynia
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 |
|---|---|---|
| Transcutaneous Acupoints Electrical Stimulation (TAES)Transcutaneous Acupoints Electrical Stimulation (TAES) is a kind of physical therapy that use electric current through the electrodes placed on the surface of acupoints to produce clinical effects in the human body. | Behavioural | Transcutaneous Acupoints Electrical Stimulation (TAES) |
| Auricular Acupressure (AA)Auricular acupressure (AA) is a non-invasive therapy rooted in Traditional Chinese Medicine (TCM) that involves applying pressure to specific acupoints on the ear using Vaccaria seeds. | Behavioural | Auricular Acupressure (AA) |
| No interventionNo intervention | Other | Self-Managed control group |
Primary outcome
CIPN severity - Pediatric Chemotherapy-Induced Neuropathy (P-CIN)
Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
To evaluate the severity of CIPN. The Pediatric Chemotherapy-Induced Neuropathy scale contains 13 items, with eight items to rate CIPN symptoms in the hands and feet and five items to rate the difficulty of performing functional tasks. The total score ranges from 0 to 65 with higher scores indicating more severe CIPN.
8 secondary outcomes
Sensory function outcomes
Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Sensory function outcomes
Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Motor and physical function
Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Motor and physical function
Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Motor and physical function
Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Psychological distress
Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Physical symptoms
Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Quality of life outcome
Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Acupoints Electrical Stimulation (TAES) and Auricular Acupressure (AA) in people with Chemotherapy Induced Peripheral Neuropathy (CIPN), run by The Hong Kong Polytechnic University at 1 site in China.
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 5 inclusion and 10 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: opening soon, as of the sponsor's last update on 12 Dec 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ka Yan Ho, PhD (+85254844554 ext. +85227666417, kyeva.ho@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CIPN severity - Pediatric Chemotherapy-Induced Neuropathy (P-CIN) (time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)). 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 12 Dec 2025.