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:
Collaborators:
Information provided by (Responsible Party):
Children's Oncology Group
ClinicalTrials.gov Identifier:
NCT00040911
First received: July 8, 2002
Last updated: May 29, 2013
Last verified: May 2013

July 8, 2002
May 29, 2013
April 2005
October 2009   (final data collection date for primary outcome measure)
Delayed nausea by Marrow Assessment of Nausea and Emesis at 1, 3, and 6 weeks after study completion [ Time Frame: 7 days ] [ Designated as safety issue: No ]
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.
Not Provided
Complete list of historical versions of study NCT00040911 on ClinicalTrials.gov Archive Site
  • Quality of life by QLQ C-30 at 1, 3, and 6 weeks after study completion [ Time Frame: Day 8 ] [ Designated as safety issue: No ]
  • Pain by Brief Pain Inventory at 1, 3, and 6 weeks after study completion [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    It is anticipated that Cochran-Armitage trend tests will be used to compare the results between randomized groups.
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Supportive Care
  • 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
    Undergo electroacupuncture therapy to sham points
  • Procedure: quality-of-life assessment
    Ancillary studies
  • 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).
    Interventions:
    • Procedure: electroacupuncture therapy
    • Procedure: quality-of-life assessment
  • Sham Comparator: Arm II (alternative medicine procedure)
    Patients undergo electroacupuncture therapy to sham points on the arms and legs as in arm I.
    Interventions:
    • Procedure: sham intervention
    • Procedure: quality-of-life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
January 2011
October 2009   (final data collection date for primary outcome measure)

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
Both
5 Years to 35 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00040911
ACCL04C2, NCCAM-02-AT-0172, NCI-02-AT-0172, COG-ACCL04C2, CDR0000069419
Yes
Children's Oncology Group
Children's Oncology Group
  • National Cancer Institute (NCI)
  • National Center for Complementary and Alternative Medicine (NCCAM)
Study Chair: Kara Kelly, MD Herbert Irving Comprehensive Cancer Center
Children's Oncology Group
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP