NCT00310063

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2005

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 3, 2006

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

August 10, 2018

Status Verified

August 1, 2018

Enrollment Period

2.1 years

First QC Date

March 29, 2006

Last Update Submit

August 8, 2018

Conditions

Nausea and VomitingUnspecified Childhood Solid Tumor, Protocol Specific

Keywords

nausea and vomitingunspecified childhood solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

  • reduction of chemotherapy related nausea

    assessment by questionaire of nausea during patient chemo

    6 months

Study Arms (2)

Arm I

EXPERIMENTAL

Sea Band elastic acupressure wristband

Procedure: acupressure therapy

Arm II

SHAM COMPARATOR

Sham wristband

Procedure: sham intervention

Interventions

acupressure therapyPROCEDURE

Acupressure wristband

Arm I
sham interventionPROCEDURE

Sham wristband

Arm II

Eligibility Criteria

Age2 Years - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Wake Forest University Comprehensive Cancer Center

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

Location

Related 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.

    PMID: 19134445RESULT

MeSH Terms

Conditions

NauseaVomiting

Interventions

Acupressure

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Thomas Williams McLean, MD

    Wake Forest University Health Sciences

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2006

First Posted

April 3, 2006

Study Start

April 1, 2005

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

August 10, 2018

Record last verified: 2018-08

Locations

US(1)