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NCT Number: NCT07319481

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

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. What is the feasibility of implementing TAES for children with ALL, as measured by the eligibility rate, consent rate, randomization rate etc.? 2. 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.

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Key information

Conditions

Chemotherapy Induced Peripheral Neuropathy (CIPN) Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Leukemia Leukemia, Lymphoid Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Precursor Cell Lymphoblastic Leukemia-Lymphoma

Age range

10 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Cancer Hospital of Zhengzhou University, Henan Cancer Hospital

Zhengzhou, China

Location contact

Meng Meng Luo

CONTACT

[email protected]

0371-65588251

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Feasibility measure - Screening rate

    Time frame: Baseline

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

  2. Feasibility measure - Eligibility rate

    Time frame: Baseline

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

  3. Feasibility measure - Recruitment rate

    Time frame: Baseline

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

  4. Feasibility measure - Randomization rate

    Time frame: Baseline

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

  5. 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

  6. 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.

  7. 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.

Secondary outcomes

  1. 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.

  2. 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)

    Timed Up and Go test (TUG) will be used to evaluate the physical function in children with ALL.

  3. 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)

    30-second sitting-rising test will be used to evaluate the physical function in children with ALL.

  4. Physical functioning - grip strength

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

    Handheld grip strength meter will be used to evaluate the physical function in children with ALL.

  5. Psychological distress

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

    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.

  6. Quality of life outcome

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ka Yan HO

CONTACT

[email protected]

+85254844554

Sponsors and collaborators

Lead sponsor

The Hong Kong Polytechnic University

Other

Collaborators

  • Zhengzhou University

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 6, 2026
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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