Preliminary Effectiveness and Feasibility of Transcutaneous Acupoints Electrical Stimulation on Chemotherapy-induced Peripheral Neuropathy Among Children With Acute Lymphoblastic Leukemia

NCT07319481 | Not Yet Recruiting

• 1 other identifier: Electrical stimulation
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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 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:

1. 1.What is the feasibility of implementing TAES for children with ALL, as measured by the eligibility rate, consent rate, randomization rate etc.?
2. 2.Does TAES can improve CIPN symptoms severity, physical function, psychological distress, quality of life in children with ALL compared with sham control group?

Conditions

Chemotherapy Induced Peripheral Neuropathy (CIPN)

Keywords

acute lymphoblastic leukemia; transcutaneous acupoints electrical stimulation; children; Chemotherapy induced peripheral neuropathy

Outcome Measures

Primary Outcomes (7)

• Feasibility measure - Screening rate

  The number of participants being screened divided by the number of participants available for screening

  Baseline

• Feasibility measure - Eligibility rate

  The number of eligible participants divided by the number of screened participants.

  Baseline

• Feasibility measure - Recruitment rate

  The number of eligible participants who consent to join divided by the number of eligible participants

  Baseline

• Feasibility measure - Randomization rate

  The number of consented participants being randomized divided by the number of consented participants

  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

  immediately after intervention (T1)

• Feasibility measure - Attrition rate

  The number of participants who drop out divided by the number of participants randomized.

  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.

  During the study period including 8-week intervention and 3 months follow-up

Secondary Outcomes (6)

• CIPN severity - Pediatric Chemotherapy-Induced Neuropathy (P-CIN)

  Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)

• Physical functioning - Timed Up and Go test

  Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)

• Physical functioning - 30-second sitting-rising test

  Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)

• Physical functioning - grip strength

  Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)

• Psychological distress

  Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3)

Study Arms (2)

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.

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.

Other: No intervention: sham TAES

Interventions

Transcutaneous Acupoints Electrical Stimulation (TAES) BEHAVIORAL

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.

Transcutaneous Acupoints Electrical Stimulation (TAES) group

No intervention: sham TAES OTHER

It is designed to look, feel, and be administered identically to the active treatment but lacks its core therapeutic component.

Sham control group

Eligibility Criteria

• Age: 10 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Zhengzhou University: collaborator

Study Sites (1)

The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital

Zhengzhou, China

Location

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Ka Yan HO

CONTACT

+85254844554; kyeva.ho@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 21, 2025
• First Posted: January 6, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)