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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Number of episodes of vomiting
During the first 24 hours of chemotherapy
No
Brenda Golianu
Principal Investigator
Stanford University
United States: Institutional Review Board
PEDSVAR0016
NCT01492569
May 2012
Name | Location |
---|---|
Stanford University | Stanford, California 94305 |