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

Sponsor

Wake Forest University Health Sciences (Other)

Overall Status

Completed

CT.gov ID

NCT00310063

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Location

Arms

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

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 :

Apr 1, 2005

Actual Primary Completion Date :

May 1, 2007

Actual Study Completion Date :

May 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm I Sea Band elastic acupressure wristband	Procedure: acupressure therapy Acupressure wristband
Sham Comparator: Arm II Sham wristband	Procedure: sham intervention Sham wristband

Arm

Intervention/Treatment

Experimental: Arm I

Sea Band elastic acupressure wristband

Procedure: acupressure therapy

Acupressure wristband

Sham Comparator: Arm II

Sham wristband

Procedure: sham intervention

Sham wristband

Outcome Measures

Primary Outcome Measures

reduction of chemotherapy related nausea [6 months]
assessment by questionaire of nausea during patient chemo

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 21 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Wake Forest University Health Sciences

ClinicalTrials.gov Identifier:

NCT00310063

Other Study ID Numbers:

CDR0000466312
CCCWFU-02104
CCCWFU-BG05-101

First Posted:

Apr 3, 2006

Last Update Posted:

Aug 10, 2018

Last Verified:

Aug 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Wake Forest University Health Sciences

nausea and vomiting

unspecified childhood solid tumor, protocol specific

Additional relevant MeSH terms:

Nausea

Vomiting

Study Results

No Results Posted as of Aug 10, 2018