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

Wake Forest University (WFU)

Status: Completed

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

Treatments: Procedure: acupressure therapy; Procedure: sham intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00310063

CCCWFU-BG05-101

CDR0000466312

CCCWFU-02104

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 2 to 21 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Arm I

Experimental group

Description:

Sea Band elastic acupressure wristband

Treatment:

Procedure: acupressure therapy

Arm II

Sham Comparator group

Description:

Sham wristband

Treatment:

Procedure: sham intervention