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Completed

NCT Number: NCT00040911

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

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.

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Key information

Age range

5 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

electroacupuncture therapy

Procedure

sham intervention

Procedure

Undergo electroacupuncture therapy to sham points

quality-of-life assessment

Procedure

Ancillary studies

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Children's Oncology Group

Network

Collaborators

  • National Cancer Institute (NCI)
  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2011
First posted
Jan 27, 2003
Registry last updated
May 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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