Acupressure in Preventing Nausea and Vomiting in Young Cancer Patients Receiving Chemotherapy - Full Text View

Sponsors and Collaborators:	Wake Forest University National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00310063

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

MedlinePlus related topics: Cancer Nausea and Vomiting

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Placebo Control
Official Title:	Acupressure for the Prevention of Chemotherapy-Associated Nausea and Vomiting in Children

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	30
Study Start Date:	April 2005
Primary Completion Date:	January 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Sea Band elastic acupressure wristband	Procedure: acupressure therapy Acupressure wristband
Arm II: Sham Comparator 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

Wake Forest University

National Cancer Institute (NCI)

Investigators

Study Chair:

Thomas Williams McLean, MD

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

No publications provided

Study ID Numbers:	CDR0000466312, CCCWFU-02104, CCCWFU-BG05-101
Study First Received:	March 29, 2006
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00310063 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

nausea and vomiting
unspecified childhood solid tumor, protocol specific

Study placed in the following topic categories:

Signs and Symptoms
Vomiting
Signs and Symptoms, Digestive
Nausea

Additional relevant MeSH terms:

Signs and Symptoms
Vomiting
Signs and Symptoms, Digestive
Nausea

ClinicalTrials.gov processed this record on May 07, 2009