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
- 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.
Study Type
Interventional
Primary Outcome
Delayed nausea by Marrow Assessment of Nausea and Emesis at 1, 3, and 6 weeks after study completion
Secondary Outcome
Quality of life by QLQ C-30 at 1, 3, and 6 weeks after study completion
Condition
Brain Tumors
Intervention
electroacupuncture therapy
Study Arms / Comparison Groups
Arm I (alternative medicine procedure)
Description: 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).
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
17
Start Date
April 2005
Completion Date
January 2011
Primary Completion Date
October 2009
Eligibility 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
Gender
All
Ages
5 Years - 35 Years
Accepts Healthy Volunteers
No
Contacts
Kara Kelly, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00040911
Organization ID
ACCL04C2
Secondary IDs
NCCAM-02-AT-0172
Responsible Party
Sponsor
Study Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Kara Kelly, MD, Study Chair, Herbert Irving Comprehensive Cancer Center
Verification Date
May 2013