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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2007-05-31

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.

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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.

Conditions

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Nausea and Vomiting Unspecified Childhood Solid Tumor, Protocol Specific

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I

Sea Band elastic acupressure wristband

Group Type EXPERIMENTAL

acupressure therapy

Intervention Type PROCEDURE

Acupressure wristband

Arm II

Sham wristband

Group Type SHAM_COMPARATOR

sham intervention

Intervention Type PROCEDURE

Sham wristband

Interventions

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acupressure therapy

Acupressure wristband

Intervention Type PROCEDURE

sham intervention

Sham wristband

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No