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Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting

Primary Purpose

Childhood Acute Lymphoblastic Leukemia, Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies, Ewing Sarcoma

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
electroacupuncture therapy
questionnaire administration
electroacupuncture therapy
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Childhood Acute Lymphoblastic Leukemia

Eligibility Criteria

8 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Arm I (TAPS at the P6 point)

Arm II (TAPS at a non-P6 point)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of episodes of vomiting
Severity of nausea as recorded on the visual analogue scale (VAS)
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.

Secondary Outcome Measures

Number of as needed (PRN) antiemetic medications needed

Full Information

First Posted
December 13, 2011
Last Updated
June 11, 2013
Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01492569
Brief Title
Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting
Official Title
Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Withdrawn
Why Stopped
low accrual
Study Start Date
May 2012 (undefined)
Primary Completion Date
July 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Acute Lymphoblastic Leukemia, Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies, Ewing Sarcoma, Vomiting in Infants and/or Children, Osteosarcoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (TAPS at the P6 point)
Arm Type
Experimental
Arm Description
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 Title
Arm II (TAPS at a non-P6 point)
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
electroacupuncture therapy
Other Intervention Name(s)
electroacupuncture
Intervention Description
Undergo TAPS at sham point
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
electroacupuncture therapy
Other Intervention Name(s)
electroacupuncture
Intervention Description
Undergo TAPS
Primary Outcome Measure Information:
Title
Number of episodes of vomiting
Time Frame
During the first 24 hours of chemotherapy
Title
Severity of nausea as recorded on the visual analogue scale (VAS)
Description
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.
Time Frame
During the first 24 hours of chemotherapy
Secondary Outcome Measure Information:
Title
Number of as needed (PRN) antiemetic medications needed
Time Frame
After the first 24 hours of chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenda Golianu
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

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Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting

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