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 - Full Text View

Sponsor:	National Center for Complementary and Alternative Medicine (NCCAM)
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00040911

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 and Central Nervous System Tumors Childhood Germ Cell Tumor Extragonadal Germ Cell Tumor Head and Neck Cancer Lymphoma Nausea and Vomiting Neuroblastoma Ovarian Cancer Sarcoma	Procedure: electroacupuncture therapy Procedure: management of therapy complications Procedure: nausea and vomiting therapy

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Active Control
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: Ataxia Telangiectasia Cancer 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 National Cancer Institute (NCI):

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	65
Study Start Date:	April 2002
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

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, California
Children's Hospital Central California	Recruiting
Madera, California, United States, 93638-8762
Contact: Vonda L. Crouse 559-353-5480
United States, District of Columbia
Children's National Medical Center	Recruiting
Washington, District of Columbia, United States, 20010-2970
Contact: Clinical Trials Office - Children's National Medical Center 202-884-2549
United States, Georgia
Winship Cancer Institute of Emory University	Recruiting
Atlanta, Georgia, United States, 30322
Contact: Howard M. Katzenstein 404-785-0853
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Recruiting
Bethesda, Maryland, United States, 20892-1182
Contact: Clinical Trials Office - Warren Grant Magnusen Clinical Center 888-NCI-1937
United States, Minnesota
Children's Hospitals and Clinics of Minnesota - Minneapolis	Recruiting
Minneapolis, Minnesota, United States, 55404
Contact: Clinical Trials Office - Children's Hospitals and Clinics of M 612-813-5193
United States, New York
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center	Recruiting
New York, New York, United States, 10032
Contact: Clinical Trials Office - Herbert Irving Comprehensive Cancer C 212-305-8615
SUNY Upstate Medical University Hospital	Recruiting
Syracuse, New York, United States, 13210
Contact: Clinical Trials Office - SUNY Upstate Medical University Hospi 315-464-5476
United States, Ohio
Cincinnati Children's Hospital Medical Center	Recruiting
Cincinnati, Ohio, United States, 45229-3039
Contact: Clinical Trials Office - Cincinnati Children's Hospital Medica 513-636-2799
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital	Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Gregory Kirkpatrick 918-502-6720
United States, Oregon
Legacy Emanuel Hospital and Health Center and Children's Hospital	Recruiting
Portland, Oregon, United States, 97227
Contact: Clinical Trials Office - Legacy Emanuel Hospital and Health Ce 503-413-8199
United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina	Recruiting
Charleston, South Carolina, United States, 29425
Contact: Clinical Trials Office - Hollings Cancer Center at Medical Uni 843-792-9321
United States, Washington
Children's Hospital and Regional Medical Center - Seattle	Recruiting
Seattle, Washington, United States, 98105
Contact: Douglas Hawkins 206-987-3096
Providence Cancer Center at Sacred Heart Medical Center	Recruiting
Spokane, Washington, United States, 99220-2555
Contact: Judy Felgenhauer 509-474-2777
Canada, Nova Scotia
IWK Health Centre	Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Margaret C. Yhap 902-470-8778

Sponsors and Collaborators

National Center for Complementary and Alternative Medicine (NCCAM)

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Patrick J. Mansky, MD

National Center for Complementary and Alternative Medicine (NCCAM)

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000069419, NCCAM-02-AT-0172, NCI-02-AT-0172, COG-ACCL04C2
Study First Received:	July 8, 2002
Last Updated:	November 12, 2009
ClinicalTrials.gov Identifier:	NCT00040911 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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:

Otorhinolaryngologic Neoplasms
Vomiting
Neuroectodermal Tumors, Primitive
Signs and Symptoms, Digestive
Gonadal Disorders
Neoplasms, Nerve Tissue
Pharyngeal Neoplasms
Urogenital Neoplasms
Ovarian Diseases
Central Nervous System Neoplasms
Nasopharyngeal Neoplasms
Neuroblastoma
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Signs and Symptoms

Neoplasms by Site
Neoplasms, Germ Cell and Embryonal
Nasopharyngeal Diseases
Nausea
Lymphoma
Hodgkin Disease
Nervous System Neoplasms
Endocrine Gland Neoplasms
Otorhinolaryngologic Diseases
Ovarian Neoplasms
Neoplasms by Histologic Type
Immunoproliferative Disorders
Immune System Diseases
Nervous System Diseases
Genital Neoplasms, Female

ClinicalTrials.gov processed this record on November 30, 2009