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| Sponsor: | National Center for Complementary and Alternative Medicine (NCCAM) |
|---|---|
| Collaborators: |
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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care |
| 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, 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 | |
| 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
| ClinicalTrials.gov Identifier: | NCT00040911 History of Changes |
| Obsolete Identifiers: | NCT00034411, NCT00034996 |
| Other Study ID Numbers: | CDR0000069419, NCCAM-02-AT-0172, NCI-02-AT-0172, COG-ACCL04C2 |
| Study First Received: | July 8, 2002 |
| Last Updated: | December 31, 2010 |
| Health Authority: | Unspecified |
|
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 |
|
Head and Neck Neoplasms Hodgkin Disease Lymphoma Nausea Vomiting Nervous System Neoplasms Neuroblastoma Ovarian Neoplasms Central Nervous System Neoplasms Nasopharyngeal Neoplasms Neoplasms, Germ Cell and Embryonal Neuroectodermal Tumors, Primitive, Peripheral Sarcoma Neoplasms by Site Neoplasms |
Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Signs and Symptoms, Digestive Signs and Symptoms Nervous System Diseases Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Endocrine Gland Neoplasms Ovarian Diseases |
