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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.
Verified by National Cancer Institute (NCI), July 2008

Sponsors and Collaborators: National Center for Complementary and Alternative Medicine (NCCAM)
National Cancer Institute (NCI)
Children's Oncology Group
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00040911
  Purpose

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.


Condition Intervention
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
Procedure: electroacupuncture therapy
Procedure: management of therapy complications
Procedure: nausea and vomiting therapy

MedlinePlus related topics:   Ataxia Telangiectasia    Cancer    Head and Neck Cancer    Hodgkin's Disease    Lymphoma    Nausea and Vomiting    Neuroblastoma    Ovarian Cancer    Soft Tissue Sarcoma   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Supportive Care, Randomized, Double-Blind, Active Control
Official Title:   A Randomized Study Of Electroacupuncture Treatment For Delayed Chemotherapy-Induced Nausea And Vomiting In Patients With Pediatric Solid Tumors

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Delayed nausea by Marrow Assessment of Nausea and Emesis at 1, 3, and 6 weeks after study completion

Secondary Outcome Measures:
  • 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

Estimated Enrollment:   65
Study Start Date:   April 2002
Estimated Primary Completion Date:   December 2008 (Final data collection date for primary outcome measure)

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
Ages Eligible for Study:   5 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00040911

Locations
United States, California
Children's Hospital Central California     Recruiting
      Madera, California, United States, 93638-8762
      Contact: Vonda L. Crouse     559-353-5480        
United States, Georgia
Winship Cancer Institute of Emory University     Recruiting
      Atlanta, Georgia, United States, 30322
      Contact: Howard M. Katzenstein     404-785-0853        
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office     Recruiting
      Bethesda, Maryland, United States, 20892-1182
      Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center     888-NCI-1937        
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis     Recruiting
      Minneapolis, Minnesota, United States, 55404
      Contact: Clinical Trials Office - Children's Hospitals and Clinics of M     612-813-5193        
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center     Recruiting
      New York, New York, United States, 10032
      Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C     212-305-8615        
SUNY Upstate Medical University Hospital     Recruiting
      Syracuse, New York, United States, 13210
      Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi     315-464-5476        
United States, Ohio
Cincinnati Children's Hospital Medical Center     Recruiting
      Cincinnati, Ohio, United States, 45229-3039
      Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica     513-636-0161        
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital     Recruiting
      Tulsa, Oklahoma, United States, 74136
      Contact: Gregory Kirkpatrick     918-502-6720        
United States, Oregon
Legacy Emanuel Hospital and Health Center and Children's Hospital     Recruiting
      Portland, Oregon, United States, 97227
      Contact: Clinical Trials Office - Legacy Emanuel Hospital and Health Ce     503-413-8199        
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina     Recruiting
      Charleston, South Carolina, United States, 29425
      Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni     843-792-9321        
United States, Washington
Children's Hospital and Regional Medical Center - Seattle     Recruiting
      Seattle, Washington, United States, 98105
      Contact: Douglas Hawkins     206-987-3096        
Providence Cancer Center at Sacred Heart Medical Center     Recruiting
      Spokane, Washington, United States, 99220-2555
      Contact: Judy Felgenhauer     509-474-2777        
Canada, Nova Scotia
IWK Health Centre     Recruiting
      Halifax, Nova Scotia, Canada, B3K 6R8
      Contact: Margaret C. Yhap     902-470-8778        

Sponsors and Collaborators

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    
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   CDR0000069419, NCCAM-02-AT-0172, NCI-02-AT-0172, COG-ACCL04C2
First Received:   July 8, 2002
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00040911
Health Authority:   Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Neuroectodermal Tumors, Primitive
Signs and Symptoms, Digestive
Malignant mesenchymal tumor
Hodgkin lymphoma, adult
Urogenital Neoplasms
Central Nervous System Neoplasms
Osteogenic sarcoma
Neoplasms, Connective and Soft Tissue
Ewing's sarcoma
Neuroepithelioma
Hodgkin Disease
Nervous System Neoplasms
Rhabdomyosarcoma
Endocrine Gland Neoplasms
Immunoproliferative Disorders
Genital Neoplasms, Female
Endocrine System Diseases
Testicular Neoplasms
Carcinoma
Neuroectodermal Tumors
Hodgkin lymphoma, childhood
Sarcoma
Testicular cancer
Carcinoma, Squamous Cell
Neoplasms, Glandular and Epithelial
Vomiting
Hodgkin's disease
Gonadal Disorders
Ewing's family of tumors
Squamous cell carcinoma

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Immune System Diseases
Neoplasms, Nerve Tissue
Nervous System Diseases
Neoplasms, Neuroepithelial
Adnexal Diseases

ClinicalTrials.gov processed this record on September 05, 2008




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