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| 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 |
| 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 |
| Estimated Enrollment: | 65 |
| Study Start Date: | April 2002 |
| Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
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 |
DISEASE CHARACTERISTICS:
Newly diagnosed malignancy of 1 of the following types:
Meets 1 of the following criteria:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and 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 | |||||
| National Center for Complementary and Alternative Medicine (NCCAM) |
| National Cancer Institute (NCI) |
| Children's Oncology Group |
| 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 
  |
| 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 |
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