search
Back to results

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

Primary Purpose

Nausea and Vomiting, Unspecified Childhood Solid Tumor, Protocol Specific

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
acupressure therapy
sham intervention
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nausea and Vomiting focused on measuring nausea and vomiting, unspecified childhood solid tumor, protocol specific

Eligibility Criteria

2 Years - 21 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Wake Forest University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Arm I

Arm II

Arm Description

Sea Band elastic acupressure wristband

Sham wristband

Outcomes

Primary Outcome Measures

reduction of chemotherapy related nausea
assessment by questionaire of nausea during patient chemo

Secondary Outcome Measures

Full Information

First Posted
March 29, 2006
Last Updated
August 8, 2018
Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00310063
Brief Title
Acupressure in Preventing Nausea and Vomiting in Young Cancer Patients Receiving Chemotherapy
Official Title
Acupressure for the Prevention of Chemotherapy-Associated Nausea and Vomiting in Children
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea and Vomiting, Unspecified Childhood Solid Tumor, Protocol Specific
Keywords
nausea and vomiting, unspecified childhood solid tumor, protocol specific

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Sea Band elastic acupressure wristband
Arm Title
Arm II
Arm Type
Sham Comparator
Arm Description
Sham wristband
Intervention Type
Procedure
Intervention Name(s)
acupressure therapy
Intervention Description
Acupressure wristband
Intervention Type
Procedure
Intervention Name(s)
sham intervention
Intervention Description
Sham wristband
Primary Outcome Measure Information:
Title
reduction of chemotherapy related nausea
Description
assessment by questionaire of nausea during patient chemo
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Williams McLean, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Study Chair
Facility Information:
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19134445
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs