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| Name | Class |
|---|---|
| Shanghai Children's Medical Center | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3) |
| Measure | Description | Time Frame |
|---|---|---|
| Sensory function outcomes | Touch sensation were measured using monofilament examination with the best of both 2 trials on each side averaged. | Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3) |
| Sensory function outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ka Yan Ho, PhD | Contact | +85254844554 | +85227666417 | kyeva.ho@polyu.edu.hk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Children Medical Center | Shanghai | China |
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| Auricular Acupressure (AA) | Behavioral | 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. |
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| No intervention | Other | No intervention |
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Vibration sensation were measured using a 128 Hz tuning fork, with the best of both 2 trials on each side averaged. |
| 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. | 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. | 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. | 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. | 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. | 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. | Baseline, immediately after intervention (T1), 1 month after intervention (T2), and 3 month after intervention (T3) |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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