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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
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	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	17 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Care Provider)
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
Study Start Date :	April 2005
Actual Primary Completion Date :	October 2009
Actual Study Completion Date :	January 2011

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Delayed nausea by Marrow Assessment of Nausea and Emesis at 1, 3, and 6 weeks after study completion [ Time Frame: 7 days ]
   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 :

1. Quality of life by QLQ C-30 at 1, 3, and 6 weeks after study completion [ Time Frame: Day 8 ]
2. Pain by Brief Pain Inventory at 1, 3, and 6 weeks after study completion [ Time Frame: Day 1 ]
   It is anticipated that Cochran-Armitage trend tests will be used to compare the results between randomized groups.

Eligibility Criteria

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Ages Eligible for Study:	5 Years to 35 Years (Child, Adult)
Sexes Eligible for Study:	All
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

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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

National Cancer Institute (NCI)

National Center for Complementary and Integrative Health (NCCIH)

Investigators

Study Chair:	Kara Kelly, MD	Herbert Irving Comprehensive Cancer Center

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ( Other Identifier: NCI ); COG-ACCL04C2 ( Other Identifier: Children's Oncology Group ); CDR0000069419 ( Other Identifier: Clinical Trials.gov )
First Posted:	January 27, 2003
Last Update Posted:	May 31, 2013
Last Verified:	May 2013

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:

Lymphoma; Neoplasms; Sarcoma; Hodgkin Disease; Head and Neck Neoplasms; Nausea; Neuroblastoma; Vomiting; Neoplasms, Germ Cell and Embryonal; Nervous System Neoplasms; Central Nervous System Neoplasms; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases	Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Site; Signs and Symptoms, Digestive; Signs and Symptoms; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Nervous System Diseases