Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting

Study Overview
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Brief Summary
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This randomized pilot clinical trial studies giving acupuncture in reducing nausea and vomiting in patients undergoing chemotherapy. Pressing and stimulating nerves at an acupuncture point on the inside of the wrist may help control nausea and vomiting during chemotherapy.

Detailed Description
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PRIMARY OBJECTIVE: I. To determine whether transcutaneous acupuncture point stimulation (TAPS) at P6 as an adjuvant treatment to standard antiemetic therapy reduces acute chemotherapy induced nausea and vomiting as compared to sham acupuncture point stimulation in children undergoing their first round of highly or moderately emetogenic chemotherapy. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I: Patients undergo TAPS at the true acupuncture point (P6) 30 minutes prior to first chemotherapy infusion and then four times a day for 20 minutes every 2 hours at 8am, 10am, 12pm, and 2pm. Patients then crossover to Arm II for the second course of chemotherapy. ARM II: Patients undergo TAPS at a sham non-acupuncture point 30 minutes prior to first chemotherapy infusion and then four times a day for 20 minutes every 2 hours at 8am, 10am, 12pm, and 2pm. Patients then crossover to Arm I for the second course of chemotherapy.

Official Title
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Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting

Conditions
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Childhood Acute Lymphoblastic Leukemia, Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies, Ewing Sarcoma, Vomiting in Infants and/or Children, Osteosarcoma

Intervention / Treatment
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* Procedure: electroacupuncture therapy
* Other: questionnaire administration
* Procedure: electroacupuncture therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with a planned admission for at least 24 hours for highly emetogenic or moderately emetogenic chemotherapy at Lucile Packard Children's Hospital or Packard El Camino. Planned to undergo at least 2 more cycles of chemotherapy. Can include but not limited to: children with high risk ALL, AML, Ewing's Sarcoma, Osteosarcoma History of vomiting with prior cycles of chemotherapy (2 episodes of emesis at minimum) despite use of conventional antiemetic medications. Age 8-21. Parent must be able to understand and willing to sign written informed consent document. Exclusion Criteria: Prior knowledge of acupuncture or experience with acupuncture or acupressure. There will be no restrictions regarding use of other Investigational Agents. Comorbid Diseases: Diagnosis of any cardiac condition (cardiomyopathy, arrhythmia, pacemaker placement). Any diagnosis requiring pediatric intensive care unit admission. Patients with brain tumor, brain metastasis (these patients often require radiation and surgery in addition to chemotherapy which may confound the results) Concomitant radiation therapy during current chemotherapy cycle. Developmental delay patients with allergy to tape or leads will be excluded from the study. Pregnant patients will be excluded from the study. Cancer survivors will not be excluded from the study as long as they are undergoing chemotherapy treatment for their current cancer therapy. HIV-positive patients will not be excluded.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (TAPS at the P6 point)<br>Patients undergo TAPS at the true acupuncture point (P6) 30 minutes prior to first chemotherapy infusion and then four times a day for 20 minutes every 2 hours at 8am, 10am, 12pm, and 2pm. Patients then crossover to Arm II for the second course of chemotherapy. | Other: questionnaire administration<br>* Ancillary studies<br>Procedure: electroacupuncture therapy<br>* Undergo TAPS<br>* Other names: electroacupuncture;|
| Sham Comparator: Arm II (TAPS at a non-P6 point)<br>Patients undergo TAPS at a sham non-acupuncture point 30 minutes prior to first chemotherapy infusion and then four times a day for 20 minutes every 2 hours at 8am, 10am, 12pm, and 2pm. Patients then crossover to Arm I for the second course of chemotherapy. | Procedure: electroacupuncture therapy<br>* Undergo TAPS at sham point<br>* Other names: electroacupuncture;Other: questionnaire administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of episodes of vomiting |  | During the first 24 hours of chemotherapy | 
| Severity of nausea as recorded on the visual analogue scale (VAS) | Measured as a continuous variable for the mean episodes of emesis. The mean VAS nausea score will also be measured as a continuous variable. Measured using the Multinational Association of Supportive Care in Cancer (MASCC) antiemesis tool. | During the first 24 hours of chemotherapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of as needed (PRN) antiemetic medications needed |  | After the first 24 hours of chemotherapy |