A Randomized Study Of Electroacupuncture Treatment For Delayed Chemotherapy-Induced Nausea And Vomiting In Patients With Pediatric Solid Tumors
- Determine the efficacy of electroacupuncture, in terms of reducing acute and delayed
chemotherapy-induced nausea, in patients with newly diagnosed pediatric sarcoma,
neuroblastoma, nasopharyngeal carcinoma, or germ cell tumors.
- Determine the efficacy of this therapy, in terms of reducing delayed
chemotherapy-induced emesis, in these patients.
- Determine the efficacy of this therapy, in terms of altering salivary cortisol levels
and fasting serum glucose and insulin levels as stress parameters, in these patients.
- Determine the efficacy of this therapy, in terms of improving the quality of life, in
- Determine the efficacy of this therapy, in terms of reducing acute nausea and emesis,
in these patients.
OUTLINE: This is a multicenter, randomized, double-blind study. Patients are stratified
according to planned treatment with cisplatin-based chemotherapy (yes vs no) and gender.
Patients are randomized to 1 of 2 arms.
- Arm I: Patients undergo electroacupuncture to specific acupuncture points on the arms
and legs over 25 minutes twice daily on days 1 and 2 and then once daily on days 3-7
during week 1 of chemotherapy course 1 (9 acupuncture treatments total).
- Arm II: Patients undergo electroacupuncture to sham points on the arms and legs as in
Quality of life is assessed at baseline, on days 1 and 8 of each treatment course, and then
after completion of the study.
PROJECTED ACCRUAL: A total of 65 patients (approximately 32 per arm) will be accrued for
this study within 2.5-3 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care
Delayed nausea by Marrow Assessment of Nausea and Emesis at 1, 3, and 6 weeks after study completion
A two-sample t-test will be used. In the event the data are not normally distributed in one or both arms, a Wilcoxon rank sum test will be used.
Kara Kelly, MD
Herbert Irving Comprehensive Cancer Center
United States: Federal Government
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office||Bethesda, Maryland 20892-1182|