Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate 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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Supportive care Active 5 to 35 NCCAM, NCI NCCAM-02-AT-0172 NCI-02-AT-0172, COG-ACCL04C2, ACCL04C2, NCT00040911

Special Category: NIH Clinical Center trial

Objectives

Primary

1. 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

1. Determine the efficacy of this therapy, in terms of reducing delayed chemotherapy-induced emesis, in these patients.
2. 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.
3. Determine the efficacy of this therapy, in terms of improving the quality of life, in these patients.
4. Determine the efficacy of this therapy, in terms of reducing acute nausea and emesis, in these patients.

Entry 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

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

Patient Characteristics:

Age:

• 5 to 35

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Platelet count greater than 50,000/mm³ (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

Expected Enrollment

A total of 65 patients (approximately 32 per arm) will be accrued for this study within 2.5-3 years.

Outcomes

Delayed nausea by Marrow Assessment of Nausea and Emesis at 1, 3, and 6 weeks after study completion

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

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.

Trial Contact Information

Trial Lead Organizations

National Center for Complementary and Alternative Medicine

Patrick Mansky, MD, Principal investigator		Ph: 301-435-4845; 888-644-6226 Email: manskyp@mail.nih.gov

Children's Oncology Group

Kara Kelly, MD, Protocol chair		Ph: 212-305-3374 Email: kk291@columbia.edu

U.S.A.
California
	Madera
	Children's Hospital Central California
		Vonda Crouse	Ph:  559-353-5480
Georgia
	Atlanta
	Winship Cancer Institute of Emory University
		Howard Katzenstein	Ph:  404-785-0853
Maryland
	Bethesda
	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
		Clinical Trials Office - Warren Grant Magnusen Clinical Center - NCI Clinical Trials Referral Office	Ph:  888-NCI-1937
Minnesota
	Minneapolis
	Children's Hospitals and Clinics of Minnesota - Minneapolis
		Clinical Trials Office - Children's Hospitals and Clinics of Minnesota	Ph:  612-813-5193
New York
	New York
	Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
		Clinical Trials Office - Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	Ph:  212-305-8615
	Syracuse
	SUNY Upstate Medical University Hospital
		Clinical Trials Office - SUNY Upstate Medical University Hospital	Ph:  315-464-5476
Ohio
	Cincinnati
	Cincinnati Children's Hospital Medical Center
		Clinical Trials Office - Cincinnati Children's Hospital Medical Center	Ph:  513-636-0161
Oklahoma
	Tulsa
	Natalie Warren Bryant Cancer Center at St. Francis Hospital
		Gregory Kirkpatrick	Ph:  918-502-6720
Oregon
	Portland
	Legacy Emanuel Hospital and Health Center and Children's Hospital
		Clinical Trials Office - Legacy Emanuel Hospital and Health Center and Children's Hospital	Ph:  503-413-8199
South Carolina
	Charleston
	Hollings Cancer Center at Medical University of South Carolina
		Clinical Trials Office - Hollings Cancer Center at Medical University of South Carolina	Ph:  843-792-9321
Washington
	Seattle
	Children's Hospital and Regional Medical Center - Seattle
		Douglas Hawkins	Ph:  206-987-3096
	Spokane
	Providence Cancer Center at Sacred Heart Medical Center
		Judy Felgenhauer	Ph:  509-474-2777
Canada
Nova Scotia
	Halifax
	IWK Health Centre
		Margaret Yhap	Ph:  902-470-8778

Registry Information
Official Title		A Randomized Study Of Electroacupuncture Treatment For Delayed Chemotherapy-Induced Nausea And Vomiting In Patients With Pediatric Solid Tumors
Trial Start Date		2002-04-24
Trial Completion Date		2008-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00040911
Date Submitted to PDQ		2002-05-07
Information Last Verified		2008-10-02