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

Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial

Official title:

Acupressure for the Prevention of Chemotherapy-Associated Nausea and Vomiting in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00310063
• Other study ID #: CDR0000466312
• Secondary ID: CCCWFU-02104CCCW
• Status: Completed
• Phase: N/A
• Start date: April 2005
• Est. completion date: May 2007

Study information

• Verified date: August 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Nausea and Vomiting
• Unspecified Childhood Solid Tumor, Protocol Specific
• Vomiting

Intervention

Procedure:
• acupressure therapy
Acupressure wristband
• sham intervention
Sham wristband

Locations

Country	Name	City	State
United States	Wake Forest University Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction of chemotherapy related nausea	assessment by questionaire of nausea during patient chemo	6 months