Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Bethesda, Maryland 20892


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.


Study summary:

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.


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


NCT ID:

NCT00040911


Primary Contact:

Study Chair
Kara Kelly, MD
Herbert Irving Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Bethesda, Maryland 20892
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.