Clinical trial 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
Official title: A Randomized Study Of Electroacupuncture Treatment For Delayed Chemotherapy-Induced Nausea And Vomiting In Patients With Pediatric Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Keywords: 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
stage III adult Hodgkin lymphoma
stage III childhood Hodgkin lymphoma
stage IV adult Hodgkin lymphoma
stage IV childhood Hodgkin lymphoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2003-01-27
Enrollment: 17
Sex: ALL
Minimum age (years): 5
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
measure: Delayed nausea by Marrow Assessment of Nausea and Emesis at 1, 3, and 6 weeks after study completion
timeFrame: 7 days
Secondary outcomes:
measure: Quality of life by QLQ C-30 at 1, 3, and 6 weeks after study completion
timeFrame: Day 8
measure: Pain by Brief Pain Inventory at 1, 3, and 6 weeks after study completion
timeFrame: Day 1
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
state: Maryland
Study officials:
affiliation: Herbert Irving Comprehensive Cancer Center
name: Kara Kelly, MD
role: STUDY_CHAIR
References: