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

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier:
NCT00310063
First received: March 29, 2006
Last updated: July 11, 2012
Last verified: July 2012
History of Changes
  Purpose

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.


Condition Intervention
Nausea and Vomiting
Unspecified Childhood Solid Tumor, Protocol Specific
 Procedure: acupressure therapy
Procedure: sham intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Acupressure for the Prevention of Chemotherapy-Associated Nausea and Vomiting in Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Comprehensive Cancer Center of Wake Forest University:

Primary Outcome Measures:
  • reduction of chemotherapy related nausea [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    assessment by questionaire of nausea during patient chemo


Enrollment: 28
Study Start Date: April 2005
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I
Sea Band elastic acupressure wristband
 Procedure: acupressure therapy
Acupressure wristband
Sham Comparator: Arm II
Sham wristband
 Procedure: sham intervention
Sham wristband

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.

  Eligibility

Ages Eligible for Study:   2 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00310063

Locations
United States, North Carolina
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
Sponsors and Collaborators
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Investigators
Study Chair: Thomas Williams McLean, MD Comprehensive Cancer Center of Wake Forest University
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Comprehensive Cancer Center of Wake Forest University
ClinicalTrials.gov Identifier: NCT00310063     History of Changes
Other Study ID Numbers: CDR0000466312, CCCWFU-02104, CCCWFU-BG05-101
Study First Received: March 29, 2006
Last Updated: July 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Comprehensive Cancer Center of Wake Forest University:
nausea and vomiting
unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013