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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Study Of Electroacupuncture Treatment For Delayed Chemotherapy-Induced Nausea And Vomiting In Patients With Pediatric Solid Tumors

Conditions
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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

Intervention / Treatment
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* Procedure: electroacupuncture therapy
* Procedure: sham intervention
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (alternative medicine procedure)<br>Patients undergo electroacupuncture therapy 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). | Procedure: electroacupuncture therapy<br> <br> Procedure: quality-of-life assessment<br>* Ancillary studies<br>|
| Sham Comparator: Arm II (alternative medicine procedure)<br>Patients undergo electroacupuncture therapy to sham points on the arms and legs as in arm I. | Procedure: sham intervention<br>* Undergo electroacupuncture therapy to sham points<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life by QLQ C-30 at 1, 3, and 6 weeks after study completion |  | 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. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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