Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting

Stanford University

Status: Withdrawn

Conditions: Vomiting in Infants and/or Children; Osteosarcoma; Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies; Ewing Sarcoma; Childhood Acute Lymphoblastic Leukemia

Treatments: Procedure: electroacupuncture therapy; Other: questionnaire administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01492569

NCI-2011-03653 (Registry Identifier)

PEDSVAR0016

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 8 to 21 years old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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0 participants in 2 patient groups

Arm I (TAPS at the P6 point)

Experimental group

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.

Treatment:

Other: questionnaire administration

Procedure: electroacupuncture therapy

Procedure: electroacupuncture therapy

Arm II (TAPS at a non-P6 point)

Sham Comparator group

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.

Treatment:

Other: questionnaire administration

Procedure: electroacupuncture therapy

Procedure: electroacupuncture therapy