Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting

June 11, 2013 updated by: Stanford University
This randomized pilot clinical trial studies giving acupuncture in reducing nausea and vomiting in patients undergoing chemotherapy. Pressing and stimulating nerves at an acupuncture point on the inside of the wrist may help control nausea and vomiting during chemotherapy.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To determine whether transcutaneous acupuncture point stimulation (TAPS) at P6 as an adjuvant treatment to standard antiemetic therapy reduces acute chemotherapy induced nausea and vomiting as compared to sham acupuncture point stimulation in children undergoing their first round of highly or moderately emetogenic chemotherapy.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo TAPS at the true acupuncture point (P6) 30 minutes prior to first chemotherapy infusion and then four times a day for 20 minutes every 2 hours at 8am, 10am, 12pm, and 2pm. Patients then crossover to Arm II for the second course of chemotherapy.

ARM II: Patients undergo TAPS at a sham non-acupuncture point 30 minutes prior to first chemotherapy infusion and then four times a day for 20 minutes every 2 hours at 8am, 10am, 12pm, and 2pm. Patients then crossover to Arm I for the second course of chemotherapy.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 21 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient with a planned admission for at least 24 hours for highly emetogenic or moderately emetogenic chemotherapy at Lucile Packard Children's Hospital or Packard El Camino.
  • Planned to undergo at least 2 more cycles of chemotherapy.
  • Can include but not limited to: children with high risk ALL, AML, Ewing's Sarcoma, Osteosarcoma
  • History of vomiting with prior cycles of chemotherapy (2 episodes of emesis at minimum) despite use of conventional antiemetic medications.
  • Age 8-21.
  • Parent must be able to understand and willing to sign written informed consent document.

Exclusion Criteria:

  • Prior knowledge of acupuncture or experience with acupuncture or acupressure.
  • There will be no restrictions regarding use of other Investigational Agents.

  • Comorbid Diseases:

    • Diagnosis of any cardiac condition (cardiomyopathy, arrhythmia, pacemaker placement).
    • Any diagnosis requiring pediatric intensive care unit admission.
    • Patients with brain tumor, brain metastasis (these patients often require radiation and surgery in addition to chemotherapy which may confound the results)
    • Concomitant radiation therapy during current chemotherapy cycle.
    • Developmental delay patients with allergy to tape or leads will be excluded from the study.
  • Pregnant patients will be excluded from the study.
  • Cancer survivors will not be excluded from the study as long as they are undergoing chemotherapy treatment for their current cancer therapy.
  • HIV-positive patients will not be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm I (TAPS at the P6 point)
Patients undergo TAPS at the true acupuncture point (P6) 30 minutes prior to first chemotherapy infusion and then four times a day for 20 minutes every 2 hours at 8am, 10am, 12pm, and 2pm. Patients then crossover to Arm II for the second course of chemotherapy.
Other: questionnaire administration
Ancillary studies
Procedure: electroacupuncture therapy
Undergo TAPS at sham point
Other Names:
  • electroacupuncture
Procedure: electroacupuncture therapy
Undergo TAPS
Other Names:
  • electroacupuncture
Sham Comparator: Arm II (TAPS at a non-P6 point)
Patients undergo TAPS at a sham non-acupuncture point 30 minutes prior to first chemotherapy infusion and then four times a day for 20 minutes every 2 hours at 8am, 10am, 12pm, and 2pm. Patients then crossover to Arm I for the second course of chemotherapy.
Other: questionnaire administration
Ancillary studies
Procedure: electroacupuncture therapy
Undergo TAPS at sham point
Other Names:
  • electroacupuncture
Procedure: electroacupuncture therapy
Undergo TAPS
Other Names:
  • electroacupuncture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of episodes of vomiting
Time Frame: During the first 24 hours of chemotherapy
During the first 24 hours of chemotherapy
Severity of nausea as recorded on the visual analogue scale (VAS)
Time Frame: During the first 24 hours of chemotherapy
Measured as a continuous variable for the mean episodes of emesis. The mean VAS nausea score will also be measured as a continuous variable. Measured using the Multinational Association of Supportive Care in Cancer (MASCC) antiemesis tool.
During the first 24 hours of chemotherapy

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of as needed (PRN) antiemetic medications needed
Time Frame: After the first 24 hours of chemotherapy
After the first 24 hours of chemotherapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Brenda Golianu, Stanford University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

December 13, 2011

First Submitted That Met QC Criteria

December 14, 2011

First Posted (Estimate)

December 15, 2011

Study Record Updates

Last Update Posted (Estimate)

June 12, 2013

Last Update Submitted That Met QC Criteria

June 11, 2013

Last Verified

June 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEDSVAR0016
  • NCI-2011-03653 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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