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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

This study is currently recruiting participants.
Information provided by National Cancer Institute (NCI)

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

Study Phase
Study Type  Interventional
Study Design  Supportive Care, Randomized, Double-Blind, Active Control
Primary Outcome Measure  Delayed nausea by Marrow Assessment of Nausea and Emesis at 1, 3, and 6 weeks after study completion
Secondary Outcome Measure  Quality of life by QLQ C-30 at 1, 3, and 6 weeks after study completion
Pain by Brief Pain Inventory at 1, 3, and 6 weeks after study completion
Condition  Brain and Central Nervous System Tumors
Childhood Germ Cell Tumor
Extragonadal Germ Cell Tumor
Head and Neck Cancer
Lymphoma
Nausea and Vomiting
Neuroblastoma
Ovarian Cancer
Sarcoma
Intervention  Procedure: electroacupuncture therapy
Procedure: management of therapy complications
Procedure: nausea and vomiting therapy
MEDLINE PMIDs
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  65
Start Date  April 2002
Completion Date
Eligibility Criteria 

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
Gender Both
Ages 5 Years to 35 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States,   Canada
Administrative Information Fields
NCT ID  NCT00040911
Organization ID CDR0000069419
Secondary IDs †† NCCAM-02-AT-0172, NCI-02-AT-0172, COG-ACCL04C2
Study Sponsor  National Center for Complementary and Alternative Medicine (NCCAM)
Collaborators †† National Cancer Institute (NCI)
Children's Oncology Group
Investigators 
Principal Investigator:     Patrick J. Mansky, MD     National Center for Complementary and Alternative Medicine (NCCAM)    
Study Chair:     Kara Kelly, MD     Herbert Irving Comprehensive Cancer Center    
Information Provided By National Cancer Institute (NCI)
Verification Date June 2008
First Received Date  July 8, 2002
Last Updated Date June 17, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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