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

Children's Oncology Group

Status: Completed

Conditions: Vomiting; Nausea; Sarcoma; Neuroblastoma; Extragonadal Germ Cell Tumor; Central Nervous System Tumors; Brain Tumors; Childhood Germ Cell Tumor; Lymphoma; Ovarian Cancer; Head and Neck Cancer

Treatments: Procedure: electroacupuncture therapy; Procedure: sham intervention; Procedure: quality-of-life assessment

Study type: Interventional

Funder types: NETWORK; NIH

Identifiers

NCT00040911

NCCAM-02-AT-0172

ACCL04C2

COG-ACCL04C2 (Other Identifier)

NCI-02-AT-0172 (Other Identifier)

CDR0000069419 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 5 to 35 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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17 participants in 2 patient groups

Arm I (alternative medicine procedure)

Experimental group

Description:

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).

Treatment:

Procedure: quality-of-life assessment

Procedure: electroacupuncture therapy

Arm II (alternative medicine procedure)

Sham Comparator group

Description:

Patients undergo electroacupuncture therapy to sham points on the arms and legs as in arm I.

Treatment:

Procedure: quality-of-life assessment

Procedure: sham intervention