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

Sponsor

Children's Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00040911

Collaborator

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

Enrollment

Location

Arms

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
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	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

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

Study Start Date :

Apr 1, 2005

Actual Primary Completion Date :

Oct 1, 2009

Actual Study Completion Date :

Jan 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Delayed nausea by Marrow Assessment of Nausea and Emesis at 1, 3, and 6 weeks after study completion [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 [Day 8]
Pain by Brief Pain Inventory at 1, 3, and 6 weeks after study completion [Day 1]
It is anticipated that Cochran-Armitage trend tests will be used to compare the results between randomized groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 35 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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