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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):
Wake Forest University Health Sciences
ClinicalTrials.gov Identifier:
NCT00310063
First received: March 29, 2006
Last updated: February 21, 2017
Last verified: February 2017
  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: No masking
Primary Purpose: Supportive Care
Official Title: Acupressure for the Prevention of Chemotherapy-Associated Nausea and Vomiting in Children

Resource links provided by NLM:


Further study details as provided by Wake Forest University Health Sciences:

Primary Outcome Measures:
  • reduction of chemotherapy related nausea [ Time Frame: 6 months ]
    assessment by questionaire of nausea during patient chemo


Enrollment: 28
Study Start Date: April 2005
Study Completion Date: May 2007
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   (Child, Adult)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Health Sciences
National Cancer Institute (NCI)
Investigators
Study Chair: Thomas Williams McLean, MD Wake Forest University Health Sciences
  More Information

Publications:
Responsible Party: Wake Forest University Health Sciences
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: February 21, 2017

Keywords provided by Wake Forest University Health Sciences:
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 25, 2017