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

Not Applicable

Completed

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

• Registration Number: NCT00040911
• Lead Sponsor: Children's Oncology Group

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.

Study Timeline

• Study First Submitted: 2002-07-08
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Study Start: 2005-04
• Primary Completion: 2009-10
• Study Completion: 2011-01
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (alternative medicine procedure)	electroacupuncture therapy	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).
Arm I (alternative medicine procedure)	quality-of-life assessment	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).
Arm II (alternative medicine procedure)	sham intervention	Patients undergo electroacupuncture therapy to sham points on the arms and legs as in arm I.
Arm II (alternative medicine procedure)	quality-of-life assessment	Patients undergo electroacupuncture therapy to sham points on the arms and legs as in arm I.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office; 🇺🇸 Bethesda, Maryland, United States