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Clinical Trial Details — Status: Withdrawn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Status Withdrawn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Status Withdrawn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. completion date
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


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
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