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
This study has been completed.
Sponsor:
Children's Oncology Group
Collaborators:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00040911
First received: July 8, 2002
Last updated: May 29, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 Tumors Central Nervous System Tumors Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Head and Neck Cancer Lymphoma Nausea Vomiting Neuroblastoma Ovarian Cancer Sarcoma |
Procedure: electroacupuncture therapy Procedure: sham intervention Procedure: quality-of-life assessment |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) 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 |
Resource links provided by NLM:
MedlinePlus related topics:
Brain Cancer
Cancer
Childhood Brain Tumors
Head and Neck Cancer
Hodgkin Disease
Lymphoma
Nausea and Vomiting
Neuroblastoma
Ovarian Cancer
Soft Tissue Sarcoma
U.S. FDA Resources
Further study details as provided by Children's Oncology Group:
Primary Outcome Measures:
- Delayed nausea by Marrow Assessment of Nausea and Emesis at 1, 3, and 6 weeks after study completion [ Time Frame: 7 days ] [ Designated as safety issue: No ]A two-sample t-test will be used. In the event the data are not normally distributed in one or both arms, a Wilcoxon rank sum test will be used.
Secondary Outcome Measures:
- Quality of life by QLQ C-30 at 1, 3, and 6 weeks after study completion [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
- Pain by Brief Pain Inventory at 1, 3, and 6 weeks after study completion [ Time Frame: Day 1 ] [ Designated as safety issue: No ]It is anticipated that Cochran-Armitage trend tests will be used to compare the results between randomized groups.
| Enrollment: | 17 |
| Study Start Date: | April 2005 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm I (alternative medicine procedure)
Patients undergo electroacupuncture therapy 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).
|
Procedure: electroacupuncture therapy
Procedure: quality-of-life assessment
Ancillary studies
|
|
Sham Comparator: Arm II (alternative medicine procedure)
Patients undergo electroacupuncture therapy to sham points on the arms and legs as in arm I.
|
Procedure: sham intervention
Undergo electroacupuncture therapy to sham points
Procedure: quality-of-life assessment
Ancillary studies
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 5 Years to 35 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00040911
Locations
| United States, Maryland | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |
| Bethesda, Maryland, United States, 20892-1182 | |
Sponsors and Collaborators
Children's Oncology Group
Investigators
| Study Chair: | Kara Kelly, MD | Herbert Irving Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Children's Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00040911 History of Changes |
| Obsolete Identifiers: | NCT00034411, NCT00034996 |
| Other Study ID Numbers: | ACCL04C2, NCCAM-02-AT-0172, NCI-02-AT-0172, COG-ACCL04C2, CDR0000069419 |
| Study First Received: | July 8, 2002 |
| Last Updated: | May 29, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Children's Oncology Group:
|
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 |
Additional relevant MeSH terms:
|
Brain Neoplasms Head and Neck Neoplasms Hodgkin Disease Lymphoma Nausea Nervous System Neoplasms Neuroblastoma Ovarian Neoplasms Vomiting Central Nervous System Neoplasms Nasopharyngeal Neoplasms Neoplasms, Germ Cell and Embryonal Neuroectodermal Tumors, Primitive, Peripheral Sarcoma Neoplasms by Site |
Neoplasms Brain Diseases Central Nervous System Diseases Nervous System Diseases Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Signs and Symptoms, Digestive Signs and Symptoms Neuroectodermal Tumors, Primitive Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Glandular and Epithelial |
ClinicalTrials.gov processed this record on June 17, 2013