Osteosarcoma Clinical Trial
Official title:
Acupuncture Point Stimulation for Treatment of Chemotherapy Nausea and Vomiting
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
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