Patient case: 4-year-old female with neuroblastoma; genetic feature: ALK

Clinical trial: Electroacupuncture in Treating Delayed Nausea and Vomiting in Patients Receiving Chemotherapy For Newly Diagnosed Childhood Sarcoma, Neuroblastoma, Nasopharyngeal Cancer, Germ Cell Tumors, or Hodgkin Lymphoma

Summary: 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.

Detailed description: 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.

Eligibility: DISEASE CHARACTERISTICS:
  -  Newly diagnosed malignancy of 1 of the following types:
  -  Pediatric sarcoma
  -  Neuroblastoma
  -  Nasopharyngeal carcinoma
  -  Germ cell tumor
  -  Hodgkin lymphoma
  -  Meets 1 of the following criteria:
  -  Eligible for Children's Oncology Group (COG) protocol for sarcoma, neuroblastoma, or germ cell tumor
  -  Eligible for NCI Pediatric Oncology Branch (POB) protocol for sarcoma
  -  Following COG-approved standard treatment regimen for sarcoma, neuroblastoma, nasopharyngeal carcinoma, or germ cell tumor
  -  Enrolled on the POB natural history protocol 98-C-0037
  -  Planned treatment, according to COG or POB protocols, that includes a cisplatin- and/or doxorubicin-containing regimen for sarcoma, neuroblastoma, nasopharyngeal carcinoma, germ cell tumor, or Hodgkin lymphoma OR either a cyclophosphamide/ifosfamide-doxorubicin-containing or cyclophosphamide/dactinomycin-containing regimen for rhabdomyosarcoma
  -  No clinical or radiographic signs of spinal cord compression
  PATIENT CHARACTERISTICS:
  Age:
  -  5 to 35
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Platelet count greater than 50,000/mm^3 (transfusion independent)
  -  No clotting disorders, including hemophilia
  Hepatic:
  -  PT and PTT normal (within 10% of institution's upper limit of normal)
  Renal:
  -  Not specified
  Other:
  -  Not pregnant
  -  No casting of 1 or more extremities
  -  No other condition that would preclude access to acupuncture points
  -  No cognitive impairment
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Not specified
  Chemotherapy:
  -  See Disease Characteristics
  -  No prior systemic chemotherapy
  Endocrine therapy:
  -  More than 4 weeks since prior glucocorticoid therapy
  -  No concurrent glucocorticoid therapy
  Radiotherapy:
  -  Not specified
  Surgery:
  -  Not specified
  Other:
  -  No prior acupuncture
  -  No concurrent anticoagulants

Relevance to patient case: not relevant