RATIONALE: Electroacupuncture may help to reduce or prevent delayed nausea and vomiting in patients treated with chemotherapy. PURPOSE: This randomized clinical trial is studying the effectiveness of electroacupuncture in treating delayed nausea and vomiting in patients who are receiving chemotherapy for newly diagnosed childhood sarcoma, neuroblastoma, nasopharyngeal cancer, germ cell tumors, or Hodgkin lymphoma.
OBJECTIVES: Primary * 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. Secondary * 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 these patients. * 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 arm I. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
17
Undergo electroacupuncture therapy to sham points
Ancillary studies
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
Bethesda, Maryland, United States
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.
Time frame: 7 days
Quality of life by QLQ C-30 at 1, 3, and 6 weeks after study completion
Time frame: Day 8
Pain by Brief Pain Inventory at 1, 3, and 6 weeks after study completion
It is anticipated that Cochran-Armitage trend tests will be used to compare the results between randomized groups.
Time frame: Day 1
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