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
Condition: Brain Tumors; Central Nervous System Tumors; Childhood Germ Cell Tumor; Extragonadal Germ Cell Tumor; Head and Neck Cancer; Lymphoma; Nausea; Vomiting; Neuroblastoma; Ovarian Cancer; Sarcoma
MeSH terms: Lymphoma; Neoplasms; Sarcoma; Neuroblastoma; Neoplasms, Germ Cell and Embryonal; Nervous System Neoplasms; Central Nervous System Neoplasms; Nausea; Vomiting
Study type: Interventional

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.
    

Intervention name(s): electroacupuncture therapy; sham intervention; quality-of-life assessment
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Undergo electroacupuncture therapy to sham points; Ancillary studies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: nausea and vomiting; localized osteosarcoma; metastatic osteosarcoma; nonmetastatic childhood soft tissue sarcoma; metastatic childhood soft tissue sarcoma; previously untreated childhood rhabdomyosarcoma; localized Ewing sarcoma/peripheral primitive neuroectodermal tumor; metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor; childhood teratoma; childhood extragonadal germ cell tumor; childhood malignant testicular germ cell tumor; childhood malignant ovarian germ cell tumor; childhood central nervous system germ cell tumor; localized resectable neuroblastoma; localized unresectable neuroblastoma; disseminated neuroblastoma; regional neuroblastoma; stage 4S neuroblastoma; stage I lymphoepithelioma of the nasopharynx; stage I squamous cell carcinoma of the nasopharynx; stage II lymphoepithelioma of the nasopharynx; stage II squamous cell carcinoma of the nasopharynx; stage III lymphoepithelioma of the nasopharynx; stage III squamous cell carcinoma of the nasopharynx; stage IV lymphoepithelioma of the nasopharynx; stage IV squamous cell carcinoma of the nasopharynx; stage I adult Hodgkin lymphoma; stage I childhood Hodgkin lymphoma; stage II adult Hodgkin lymphoma; stage II childhood Hodgkin lymphoma; stage III adult Hodgkin lymphoma; stage III childhood Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; stage IV childhood Hodgkin lymphoma