Basic Trial Information
|No phase specified||Supportive care||Completed||5 to 35||NCI, Other||ACCL04C2|
NCCAM-02-AT-0172, NCI-02-AT-0172, COG-ACCL04C2, CDR0000069419, NCT00040911
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.
Further Study Information
- 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.
- 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.
- Newly diagnosed malignancy of 1 of the following types:
- 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
- Platelet count greater than 50,000/mm^3 (transfusion independent)
- No clotting disorders, including hemophilia
- PT and PTT normal (within 10% of institution's upper limit of normal)
- No casting of 1 or more extremities
- No other condition that would preclude access to acupuncture points
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior systemic chemotherapy
- More than 4 weeks since prior glucocorticoid therapy
- No concurrent glucocorticoid therapy
- No concurrent anticoagulants
Trial Lead Organizations/Sponsors
Children's Oncology Group
- National Cancer Institute
- National Center for Complementary and Integrative Health (NCCIH)
Kara Kelly, Study Chair
Link to the current ClinicalTrials.gov record.
NLM Identifier NCT00040911
ClinicalTrials.gov processed this data on April 09, 2015
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