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

Lymphoma Clinical Trial

Official title:

A Randomized Study Of Electroacupuncture Treatment For Delayed Chemotherapy-Induced Nausea And Vomiting In Patients With Pediatric Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00040911
• Other study ID #: ACCL04C2
• Secondary ID: NCCAM-02-AT-0172
• Status: Completed
• Phase: N/A
• First received: July 8, 2002
• Last updated: May 29, 2013
• Start date: April 2005
• Est. completion date: January 2011

Study information

• Verified date: May 2013
• Source: Children's Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Other known NCT identifiers

• NCT00034411
• NCT00034996

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: January 2011
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 35 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Brain Tumors
• Central Nervous System Neoplasms
• Central Nervous System Tumors
• Childhood Germ Cell Tumor
• Extragonadal Germ Cell Tumor
• Head and Neck Cancer
• Head and Neck Neoplasms
• Hodgkin Disease
• Lymphoma
• Nausea
• Neoplasms
• Neoplasms, Germ Cell and Embryonal
• Nervous System Neoplasms
• Neuroblastoma
• Ovarian Cancer
• Sarcoma
• Vomiting

Intervention

Procedure:
• electroacupuncture therapy

• sham intervention
Undergo electroacupuncture therapy to sham points
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office	Bethesda	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Children's Oncology Group	National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delayed nausea by Marrow Assessment of Nausea and Emesis at 1, 3, and 6 weeks after study completion	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.	7 days	No
Secondary	Quality of life by QLQ C-30 at 1, 3, and 6 weeks after study completion		Day 8	No
Secondary	Pain by Brief Pain Inventory at 1, 3, and 6 weeks after study completion	It is anticipated that Cochran-Armitage trend tests will be used to compare the results between randomized groups.	Day 1	No