Chemotherapy Induced Peripheral Neuropathy (CIPN)NCT07319481
Preliminary Effectiveness and Feasibility of Transcutaneous Acupoints Electrical Stimulation on Chemotherapy-induced Peripheral Neuropathy Among Children With Acute Lymphoblastic Leukemia
A study testing Transcutaneous Acupoints Electrical Stimulation (TAES) in people with Chemotherapy Induced Peripheral Neuropathy (CIPN), run by The Hong Kong Polytechnic University at 1 site in China.
Trial summary
The first goal of this clinical trial is to assess the feasibility of transcutaneous acupoints electrical stimulation (TAES) on children with acute lymphoblastic leukemia (ALL). The second goal of this clinical trial is to evaluate the preliminary effectiveness of TAES on subject chemotherapy induced peripheral… Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Chemotherapy Induced Peripheral Neuropathy (CIPN)
- What is being tested?
- Transcutaneous Acupoints Electrical Stimulation (TAES)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 31 Jan 2027
- 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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age between 10 and 17 years old
- diagnosed with ALL
- 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
- contraindications to TEAS : 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
The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital
Zhengzhou
Meng Meng Luo, 0371-65588251, 1213347977@qq.com
About this study
Official title: Preliminary Effectiveness and Feasibility of Transcutaneous Acupoints Electrical Stimulation on Chemotherapy-induced Peripheral Neuropathy Among Chinese Children With Acute Lymphoblastic Leukemia: A Randomized Controlled Trial
The first goal of this clinical trial is to assess the feasibility of transcutaneous acupoints electrical stimulation (TAES) on children with acute lymphoblastic leukemia (ALL). The second goal of this clinical trial is to evaluate the preliminary effectiveness of TAES on subject chemotherapy induced peripheral neuropathy (CIPN) symptoms severity, physical function, psychological distress, and quality of life at postintervention and at 1-, and 3-month follow-up postintervention.
The main questions it aims to answer are:
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- What is the feasibility of implementing TAES for children with ALL, as measured by the eligibility rate, consent rate, randomization rate etc.?
- Does TAES can improve CIPN symptoms severity, physical function, psychological distress, quality of life in children with ALL compared with sham control group?
This proposed research is designed to conduct a two-arm RCT comparing TAES to sham TAES in children with ALL. Subjects in TAES group will receive 8 weeks TAES on four acupoints. Subjects in sham control group will follow the same protocol as the TEAS treatment but with 0 mA, 0 Hz TAES. These two groups will be provided with a leaflet containing self-help materials for CIPN.
- Being tested
- Transcutaneous Acupoints Electrical Stimulation (TAES), No intervention: sham TAES
- Keywords
- acute lymphoblastic leukemia, transcutaneous acupoints electrical stimulation, children, Chemotherapy induced peripheral neuropathy
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
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.
No intervention: sham TAESOther
It is designed to look, feel, and be administered identically to the active treatment but lacks its core therapeutic component.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Acupoints Electrical Stimulation (TAES) group | Experimental | The intervention for TAES group will conduct 2 times per week, total 8 weeks with covering 16 sessions. The intervention will be delivered by 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 lasts for 60 minutes. Receives: Behavioral: Transcutaneous Acupoints Electrical Stimulation (TAES) |
| Sham control group | Sham comparator | We will adopt a sham control for participants in the sham control group with the same frequency, duration and procedures as the TAES in the experimental group. However, only electrodes will be attached on the four bilateral acupoints, but without any electrical stimulation. Receives: Other: No intervention: sham TAES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility measure - Screening rate
The number of participants being screened divided by the number of participants available for screening
Measured: Baseline
Feasibility measure - Eligibility rate
The number of eligible participants divided by the number of screened participants.
Measured: Baseline
Feasibility measure - Recruitment rate
The number of eligible participants who consent to join divided by the number of eligible participants
Measured: Baseline
Feasibility measure - Randomization rate
The number of consented participants being randomized divided by the number of consented participants
Measured: Baseline
Feasibility measure - Attendance rate
The number of participants in the experimental group and control group who complete the intervention divided by the number of participants randomized into the group
Measured: immediately after intervention (T1)
Feasibility measure - Attrition rate
The number of participants who drop out divided by the number of participants randomized.
Measured: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Feasilibility measure - Adverse events
It will be denoted as the number of adverse events reported by the participants during the study period.
Measured: During the study period including 8-week intervention and 3 months follow-up
Secondary outcomes (6)
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)
Physical functioning - Timed Up and Go test
Timed Up and Go test (TUG) will be used to evaluate the physical function in children with ALL.
Measured: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Physical functioning - 30-second sitting-rising test
30-second sitting-rising test will be used to evaluate the physical function in children with ALL.
Measured: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Physical functioning - grip strength
Handheld grip strength meter will be used to evaluate the physical function in children with ALL.
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)
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 posted6 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Zhengzhou University
- Responsible party
- Principal investigator, Dr Eva Ho, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07319481
- Sponsor's protocol ID
- Electrical stimulation
- Status last verified
- Dec 2025
- First submitted
- 21 Dec 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Effectiveness and Feasibility of Transcutaneous Acupoints Electrical Stimulation on Chemotherapy-induced Peripheral Neuropathy Among Chinese Children With Acute Lymphoblastic Leukemia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07319481
- Acronym / sponsor ID
- Electrical stimulation
- Keywords
- acute lymphoblastic leukemia, transcutaneous acupoints electrical stimulation, children, Chemotherapy induced peripheral neuropathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Zhengzhou University
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 6 Jan 2026 (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 first goal of this clinical trial is to assess the feasibility of transcutaneous acupoints electrical stimulation (TAES) on children with acute lymphoblastic leukemia (ALL). The second goal of this clinical trial is to evaluate the preliminary effectiveness of TAES on subject chemotherapy induced peripheral neuropathy (CIPN) symptoms severity, physical function, psychological distress, and quality of life at postintervention and at 1-, and 3-month follow-up postintervention.
The main questions it aims to answer are:
- What is the feasibility of implementing TAES for children with ALL, as measured by the eligibility rate, consent rate, randomization rate etc.?
- Does TAES can improve CIPN symptoms severity, physical function, psychological distress, quality of life in children with ALL compared with sham control group?
This proposed research is designed to conduct a two-arm RCT comparing TAES to sham TAES in children with ALL. Subjects in TAES group will receive 8 weeks TAES on four acupoints. Subjects in sham control group will follow the same protocol as the TEAS treatment but with 0 mA, 0 Hz TAES. These two groups will be provided with a leaflet containing self-help materials for CIPN.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Acupoints Electrical Stimulation (TAES) group | Experimental | Behavioral: Transcutaneous Acupoints Electrical Stimulation (TAES)The intervention for TAES group will conduct 2 times per week, total 8 weeks with covering 16 sessions. The intervention will be delivered by 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 lasts for 60 minutes. |
| Sham control group | Sham comparator | Other: No intervention: sham TAESWe will adopt a sham control for participants in the sham control group with the same frequency, duration and procedures as the TAES in the experimental group. However, only electrodes will be attached on the four bilateral acupoints, but without any electrical stimulation. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- age between 10 and 17 years old
- diagnosed with ALL
- 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) group |
| No intervention: sham TAESIt is designed to look, feel, and be administered identically to the active treatment but lacks its core therapeutic component. | Other | Sham control group |
Primary outcome
Feasibility measure - Screening rate
Time frame: Baseline
The number of participants being screened divided by the number of participants available for screening
Feasibility measure - Eligibility rate
Time frame: Baseline
The number of eligible participants divided by the number of screened participants.
Feasibility measure - Recruitment rate
Time frame: Baseline
The number of eligible participants who consent to join divided by the number of eligible participants
Feasibility measure - Randomization rate
Time frame: Baseline
The number of consented participants being randomized divided by the number of consented participants
Feasibility measure - Attendance rate
Time frame: immediately after intervention (T1)
The number of participants in the experimental group and control group who complete the intervention divided by the number of participants randomized into the group
Feasibility measure - Attrition rate
Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
The number of participants who drop out divided by the number of participants randomized.
Feasilibility measure - Adverse events
Time frame: During the study period including 8-week intervention and 3 months follow-up
It will be denoted as the number of adverse events reported by the participants during the study period.
6 secondary outcomes
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)
Physical functioning - Timed Up and Go test
Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Physical functioning - 30-second sitting-rising test
Time frame: Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)
Physical functioning - grip strength
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)
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 6 Jan 2026.
- 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) 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 6 Jan 2026. 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 (+85254844554, 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?
Feasibility measure - Screening rate (time frame: Baseline). The study lists 7 primary outcomes in all. 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 6 Jan 2026.