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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00040911
First Posted: January 27, 2003
Last Update Posted: May 31, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Cancer Institute (NCI)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
Children's Oncology Group
  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 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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Children's Oncology Group:

Primary Outcome Measures:
  • 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:
  • Quality of life by QLQ C-30 at 1, 3, and 6 weeks after study completion [ Time Frame: Day 8 ]
  • 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.
Enrollment: 17
Study Start Date: April 2005
Study Completion Date: January 2011
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00040911


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

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 Submitted: July 8, 2002
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