|
|
![]() |
![]() |
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
||||||||||||||||||||||||||||||||||||
| 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
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. |
||||||||
| 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 ![]() |
||||||||
| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 65 | ||||||||
| Start Date † | April 2002 | ||||||||
| Completion Date | |||||||||
| Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY: Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
|
||||||||
| 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 † |
|
||||||||
| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | June 2008 | ||||||||
| First Received Date † | July 8, 2002 | ||||||||
| Last Updated Date | June 17, 2008 | ||||||||