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Completed

NCT Number: NCT00310063

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

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.

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Key information

Age range

2 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acupressure therapy

Procedure

Acupressure wristband

sham intervention

Procedure

Sham wristband

Primary outcomes

  1. reduction of chemotherapy related nausea

    Time frame: 6 months

    assessment by questionaire of nausea during patient chemo

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Apr 3, 2006
Registry last updated
Aug 10, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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