Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting - Full Text View

Purpose

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.

Condition	Intervention
Childhood Acute Lymphoblastic Leukemia Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies Ewing Sarcoma Vomiting in Infants and/or Children Osteosarcoma	Procedure: electroacupuncture therapy Other: questionnaire administration

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care
Official Title:	Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting

Resource links provided by NLM:

Genetics Home Reference related topics: Ewing sarcoma familial acute myeloid leukemia with mutated CEBPA

MedlinePlus related topics: Acupuncture Acute Bronchitis Acute Myeloid Leukemia Cancer Chronic Lymphocytic Leukemia Leukemia Nausea and Vomiting Soft Tissue Sarcoma

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Number of episodes of vomiting [ Time Frame: During the first 24 hours of chemotherapy ] [ Designated as safety issue: No ]
Severity of nausea as recorded on the visual analogue scale (VAS) [ Time Frame: During the first 24 hours of chemotherapy ] [ Designated as safety issue: No ]
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 [ Time Frame: After the first 24 hours of chemotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment:	35
Study Start Date:	May 2012
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 Other Name: 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.	Procedure: electroacupuncture therapy Undergo TAPS at sham point Other Name: electroacupuncture Other: questionnaire administration Ancillary studies

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.

Eligibility

Ages Eligible for Study:	8 Years to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492569

Locations

United States, California
Stanford University	Recruiting
Stanford, California, United States, 94305
Contact: Brenda Golianu 650-723-5728 bgolianu@stanford.edu
Principal Investigator: Brenda Golianu

Sponsors and Collaborators

Stanford University

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Brenda Golianu

Stanford University

More Information

No publications provided

Responsible Party:	Stanford University
ClinicalTrials.gov Identifier:	NCT01492569 History of Changes
Other Study ID Numbers:	PEDSVAR0016, NCI-2011-03653
Study First Received:	December 13, 2011
Last Updated:	December 11, 2012
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Neoplasms
Leukemia
Leukemia, Lymphoid
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Osteosarcoma
Vomiting
Sarcoma, Ewing's
Neuroectodermal Tumors, Primitive, Peripheral
Sarcoma
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases

Immunoproliferative Disorders
Immune System Diseases
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Signs and Symptoms, Digestive
Signs and Symptoms
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on May 16, 2013