Know Cancer

or
forgot password

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


N/A
2 Years
21 Years
Not Enrolling
Both
Nausea and Vomiting, Unspecified Childhood Solid Tumor, Protocol Specific

Thank you

Trial Information

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


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

reduction of chemotherapy related nausea

Outcome Description:

assessment by questionaire of nausea during patient chemo

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Thomas Williams McLean, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CDR0000466312

NCT ID:

NCT00310063

Start Date:

April 2005

Completion Date:

Related Keywords:

  • Nausea and Vomiting
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • nausea and vomiting
  • unspecified childhood solid tumor, protocol specific
  • Nausea
  • Vomiting

Name

Location

Wake Forest University Comprehensive Cancer Center Winston-Salem, North Carolina  27157-1096