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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

2014-07-23 21:52:42 | BioPortfolio

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.

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

Allocation: Randomized, Control: Active Control, Masking: Double-Blind, Primary Purpose: Supportive Care

Conditions

Brain and Central Nervous System Tumors

Intervention

electroacupuncture therapy, management of therapy complications, nausea and vomiting therapy

Location

Children's Hospital Central California
Madera
California
United States
93638-8762

Status

Recruiting

Source

National Cancer Institute (NCI)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:52:42-0400

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