Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting

NCT ID: NCT01492569

Last Updated: 2013-06-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

questionnaire administration

Intervention Type: OTHER

Ancillary studies

electroacupuncture therapy

Intervention Type: PROCEDURE

Undergo TAPS

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.

Group Type: SHAM_COMPARATOR

electroacupuncture therapy

Intervention Type: PROCEDURE

Undergo TAPS at sham point

questionnaire administration

Intervention Type: OTHER

Ancillary studies

Interventions

electroacupuncture therapy

Undergo TAPS at sham point

Intervention Type: PROCEDURE

questionnaire administration

Ancillary studies

Intervention Type: OTHER

electroacupuncture therapy

Undergo TAPS

Intervention Type: PROCEDURE

Other Intervention Names

electroacupuncture; electroacupuncture

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brenda Golianu

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Other Identifiers

NCI-2011-03653

Identifier Type: REGISTRY

Identifier Source: secondary_id

PEDSVAR0016

Identifier Type: -

Identifier Source: org_study_id