Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting

Osteosarcoma Clinical Trial

Official title:

Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01492569
• Other study ID #: PEDSVAR0016
• Secondary ID: NCI-2011-03653
• Status: Withdrawn
• Phase: N/A
• First received: December 13, 2011
• Last updated: June 11, 2013
• Start date: May 2012

Study information

• Verified date: June 2013
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 21 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Childhood Acute Lymphoblastic Leukemia
• Childhood Acute Myeloid Leukemia/Other Myeloid Malignancies
• Ewing Sarcoma
• Leukemia
• Leukemia, Lymphoid
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Osteosarcoma
• Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Sarcoma, Ewing
• Vomiting
• Vomiting in Infants and/or Children

Intervention

Procedure:
• electroacupuncture therapy
Undergo TAPS at sham point

Other:
• questionnaire administration
Ancillary studies

Procedure:
• electroacupuncture therapy
Undergo TAPS

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of episodes of vomiting		During the first 24 hours of chemotherapy	No
Primary	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.	During the first 24 hours of chemotherapy	No
Secondary	Number of as needed (PRN) antiemetic medications needed		After the first 24 hours of chemotherapy	No