Nausea and Vomiting, Unspecified Childhood Solid Tumor, Protocol Specific
Conditions
Keywords
nausea and vomiting, unspecified childhood solid tumor, protocol specific
Brief summary
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
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.
Interventions
PROCEDUREacupressure therapy
Acupressure wristband
PROCEDUREsham intervention
Sham wristband
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| reduction of chemotherapy related nausea | 6 months | assessment by questionaire of nausea during patient chemo |
Countries
United States
Outcome results
None listed