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Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting


N/A
8 Years
21 Years
Not Enrolling
Both
Childhood Acute Lymphoblastic Leukemia, Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies, Ewing Sarcoma, Vomiting in Infants and/or Children, Osteosarcoma

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Trial Information

Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Number of episodes of vomiting

Outcome Time Frame:

During the first 24 hours of chemotherapy

Safety Issue:

No

Principal Investigator

Brenda Golianu

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

PEDSVAR0016

NCT ID:

NCT01492569

Start Date:

May 2012

Completion Date:

Related Keywords:

  • Childhood Acute Lymphoblastic Leukemia
  • Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies
  • Ewing Sarcoma
  • Vomiting in Infants and/or Children
  • Osteosarcoma
  • Neoplasms
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Osteosarcoma
  • Vomiting
  • Sarcoma, Ewing's
  • Neuroectodermal Tumors, Primitive, Peripheral
  • Sarcoma

Name

Location

Stanford UniversityStanford, California  94305