Acupressure in Preventing Nausea and Vomiting in Young Cancer Patients Receiving Chemotherapy
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|ClinicalTrials.gov Identifier: NCT00310063|
Recruitment Status : Completed
First Posted : April 3, 2006
Last Update Posted : February 23, 2017
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 or disease||Intervention/treatment||Phase|
|Nausea and Vomiting Unspecified Childhood Solid Tumor, Protocol Specific||Procedure: acupressure therapy Procedure: sham intervention||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Acupressure for the Prevention of Chemotherapy-Associated Nausea and Vomiting in Children|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||May 2007|
Experimental: Arm I
Sea Band elastic acupressure wristband
Procedure: acupressure therapy
Sham Comparator: Arm II
Procedure: sham intervention
- reduction of chemotherapy related nausea [ Time Frame: 6 months ]assessment by questionaire of nausea during patient chemo
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00310063
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|Study Chair:||Thomas Williams McLean, MD||Wake Forest University Health Sciences|