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

This study has been completed.
Sponsor:
Collaborator:
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

March 29, 2006
July 11, 2012
April 2005
May 2007   (final data collection date for primary outcome measure)
reduction of chemotherapy related nausea [ Time Frame: 6 months ] [ Designated as safety issue: No ]
assessment by questionaire of nausea during patient chemo
Not Provided
Complete list of historical versions of study NCT00310063 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Acupressure in Preventing Nausea and Vomiting in Young Cancer Patients Receiving Chemotherapy
Acupressure for the Prevention of Chemotherapy-Associated Nausea and Vomiting in Children

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Nausea and Vomiting
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • Procedure: acupressure therapy
    Acupressure wristband
  • Procedure: sham intervention
    Sham wristband
  • Experimental: Arm I
    Sea Band elastic acupressure wristband
    Intervention: Procedure: acupressure therapy
  • Sham Comparator: Arm II
    Sham wristband
    Intervention: Procedure: sham intervention
Jones E, Isom S, Kemper KJ, McLean TW. Acupressure for chemotherapy-associated nausea and vomiting in children. J Soc Integr Oncol. 2008 Fall;6(4):141-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
Not Provided
May 2007   (final data collection date for primary outcome measure)

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
Both
2 Years to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00310063
CDR0000466312, CCCWFU-02104, CCCWFU-BG05-101
No
Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
National Cancer Institute (NCI)
Study Chair: Thomas Williams McLean, MD Comprehensive Cancer Center of Wake Forest University
Comprehensive Cancer Center of Wake Forest University
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP