Acupressure in Preventing Nausea and Vomiting in Young Cancer Patients Receiving Chemotherapy

Study Overview
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Brief Summary
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RATIONALE: Using acupressure wrist bands to press and stimulate nerves at an acupressure point on the inside of the wrist may help control nausea and vomiting caused by chemotherapy. PURPOSE: This randomized clinical trial is studying how well acupressure works in preventing nausea and vomiting in young cancer patients receiving chemotherapy.

Detailed Description
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OBJECTIVES: Determine the feasibility of implementing an acupressure therapy for the prevention of chemotherapy-associated nausea in children with cancer. Test the hypothesis that acupressure bands will prevent chemotherapy-associated nausea and vomiting in children, when compared to placebo acupressure (wrist bands without acupressure). Develop a competitive grant application for a large, multi-institutional randomized controlled trial of the efficacy of acupressure in preventing chemotherapy-associated nausea in children. OUTLINE: This is a prospective, randomized, placebo-controlled, crossover, pilot study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients wear Sea-Band elastic acupressure wristbands on each wrist beginning approximately 1 hour before beginning their first inpatient chemotherapy session and continuing for at least 24 hours after completing chemotherapy. Patients do not wear wristbands for their second chemotherapy session. Patients wear placebo wristbands on each wrist beginning approximately 1 hour before their third chemotherapy session and continuing for at least 24 hours after completing chemotherapy. Arm II: Patients wear placebo wristbands on each wrist beginning approximately 1 hour before their first chemotherapy session and continuing for at least 24 hours after completing chemotherapy. Patients do not wear wristbands for their second chemotherapy session. Patients wear Sea-Band acupressure wristbands on each wrist beginning approximately 1 hour before their third chemotherapy session and continuing for at least 24 hours after completing chemotherapy. All patients also receive standard antiemetic therapy. PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Official Title
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Acupressure for the Prevention of Chemotherapy-Associated Nausea and Vomiting in Children

Conditions
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Nausea and Vomiting, Unspecified Childhood Solid Tumor, Protocol Specific

Intervention / Treatment
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* Procedure: acupressure therapy
* Procedure: sham intervention


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Patients must receive in-patient primary oncology care at least monthly at Brenner Children's Hospital Patients may have any type of cancer Must be receiving at least 1 of the following chemotherapy agents as an inpatient: An alkylating agent (e.g., cisplatin, cyclophosphamide, or ifosfamide) An antitumor antibiotic (e.g., doxorubicin, daunomycin, dactinomycin, or mitoxantrone) High-dose cytarabine PATIENT CHARACTERISTICS: Patient's primary caregiver must speak English PRIOR CONCURRENT THERAPY: See Disease Characteristics

Ages Eligible for Study
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Minimum Age: 2 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I<br>Sea Band elastic acupressure wristband | Procedure: acupressure therapy<br>* Acupressure wristband<br>|
| Sham Comparator: Arm II<br>Sham wristband | Procedure: sham intervention<br>* Sham wristband<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| reduction of chemotherapy related nausea | assessment by questionaire of nausea during patient chemo | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nausea and vomiting, unspecified childhood solid tumor, protocol specific