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

A Randomized Study Of Electroacupuncture Treatment For Delayed Chemotherapy-Induced Nausea And Vomiting In Patients With Pediatric Solid Tumors

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.

Study Overview

• Status: Completed
• Conditions: Sarcoma; Lymphoma; Head and Neck Cancer; Nausea; Vomiting; Ovarian Cancer; Neuroblastoma; Brain Tumors; Central Nervous System Tumors; Extragonadal Germ Cell Tumor; Childhood Germ Cell Tumor
• Intervention / Treatment: Procedure: quality-of-life assessment; Procedure: electroacupuncture therapy; Procedure: sham intervention

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
• Enrollment (Actual): 17
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892-1182
      • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 5 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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: quality-of-life assessment; Ancillary studies; Procedure: electroacupuncture therapy
Sham Comparator: Arm II (alternative medicine procedure); Patients undergo electroacupuncture therapy to sham points on the arms and legs as in arm I.	Procedure: quality-of-life assessment; Ancillary studies; Procedure: sham intervention; Undergo electroacupuncture therapy to sham points

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delayed nausea by Marrow Assessment of Nausea and Emesis at 1, 3, and 6 weeks after study completion	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.	7 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Children's Oncology Group
• Collaborators: National Cancer Institute (NCI); National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Study Chair: Kara Kelly, MD, Herbert Irving Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: April 1, 2005
• Primary Completion (Actual): October 1, 2009
• Study Completion (Actual): January 1, 2011

Study Registration Dates

• First Submitted: July 8, 2002
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): May 31, 2013
• Last Update Submitted That Met QC Criteria: May 29, 2013
• Last Verified: May 1, 2013

More Information

Terms related to this study

• Keywords: stage III squamous cell carcinoma of the nasopharynx; stage III lymphoepithelioma of the nasopharynx; stage IV squamous cell carcinoma of the nasopharynx; stage IV lymphoepithelioma of the nasopharynx; stage I squamous cell carcinoma of the nasopharynx; stage II squamous cell carcinoma of the nasopharynx; localized osteosarcoma; stage III adult Hodgkin lymphoma; stage IV adult Hodgkin lymphoma; disseminated neuroblastoma; localized unresectable neuroblastoma; stage 4S neuroblastoma; regional neuroblastoma; stage IV childhood Hodgkin lymphoma; stage III childhood Hodgkin lymphoma; metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor; metastatic osteosarcoma; stage I adult Hodgkin lymphoma; stage II adult Hodgkin lymphoma; stage I childhood Hodgkin lymphoma; stage II childhood Hodgkin lymphoma; nausea and vomiting; metastatic childhood soft tissue sarcoma; childhood central nervous system germ cell tumor; childhood teratoma; childhood malignant testicular germ cell tumor; childhood malignant ovarian germ cell tumor; childhood extragonadal germ cell tumor; previously untreated childhood rhabdomyosarcoma; nonmetastatic childhood soft tissue sarcoma; localized resectable neuroblastoma; localized Ewing sarcoma/peripheral primitive neuroectodermal tumor; stage I lymphoepithelioma of the nasopharynx; stage II lymphoepithelioma of the nasopharynx
• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Signs and Symptoms, Digestive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive; Neuroectodermal Tumors, Primitive, Peripheral; Neoplasms; Sarcoma; Lymphoma; Neoplasms, Germ Cell and Embryonal; Nausea; Vomiting; Nervous System Neoplasms; Central Nervous System Neoplasms; Neuroblastoma
• 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)