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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

Primary Purpose

Brain Tumors, Central Nervous System Tumors, Childhood Germ Cell Tumor

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
electroacupuncture therapy
sham intervention
quality-of-life assessment
Sponsored by
Children's Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Brain Tumors focused on measuring nausea and vomiting, localized osteosarcoma, metastatic osteosarcoma, nonmetastatic childhood soft tissue sarcoma, metastatic childhood soft tissue sarcoma, previously untreated childhood rhabdomyosarcoma, localized Ewing sarcoma/peripheral primitive neuroectodermal tumor, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, childhood teratoma, childhood extragonadal germ cell tumor, childhood malignant testicular germ cell tumor, childhood malignant ovarian germ cell tumor, childhood central nervous system germ cell tumor, localized resectable neuroblastoma, localized unresectable neuroblastoma, disseminated neuroblastoma, regional neuroblastoma, stage 4S neuroblastoma, stage I lymphoepithelioma of the nasopharynx, stage I squamous cell carcinoma of the nasopharynx, stage II lymphoepithelioma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx, stage III lymphoepithelioma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, stage I adult Hodgkin lymphoma, stage I childhood Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage II childhood Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage III childhood Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, stage IV childhood Hodgkin lymphoma

Eligibility Criteria

5 Years - 35 Years (Child, Adult)All SexesDoes not accept 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 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

Sites / Locations

  • Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Arm I (alternative medicine procedure)

Arm II (alternative medicine procedure)

Arm 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).

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Quality of life by QLQ C-30 at 1, 3, and 6 weeks after study completion
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.

Full Information

First Posted
July 8, 2002
Last Updated
May 29, 2013
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00040911
Brief Title
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
Official Title
A Randomized Study Of Electroacupuncture Treatment For Delayed Chemotherapy-Induced Nausea And Vomiting In Patients With Pediatric Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
Keywords
nausea and vomiting, localized osteosarcoma, metastatic osteosarcoma, nonmetastatic childhood soft tissue sarcoma, metastatic childhood soft tissue sarcoma, previously untreated childhood rhabdomyosarcoma, localized Ewing sarcoma/peripheral primitive neuroectodermal tumor, metastatic Ewing sarcoma/peripheral primitive neuroectodermal tumor, childhood teratoma, childhood extragonadal germ cell tumor, childhood malignant testicular germ cell tumor, childhood malignant ovarian germ cell tumor, childhood central nervous system germ cell tumor, localized resectable neuroblastoma, localized unresectable neuroblastoma, disseminated neuroblastoma, regional neuroblastoma, stage 4S neuroblastoma, stage I lymphoepithelioma of the nasopharynx, stage I squamous cell carcinoma of the nasopharynx, stage II lymphoepithelioma of the nasopharynx, stage II squamous cell carcinoma of the nasopharynx, stage III lymphoepithelioma of the nasopharynx, stage III squamous cell carcinoma of the nasopharynx, stage IV lymphoepithelioma of the nasopharynx, stage IV squamous cell carcinoma of the nasopharynx, stage I adult Hodgkin lymphoma, stage I childhood Hodgkin lymphoma, stage II adult Hodgkin lymphoma, stage II childhood Hodgkin lymphoma, stage III adult Hodgkin lymphoma, stage III childhood Hodgkin lymphoma, stage IV adult Hodgkin lymphoma, stage IV childhood Hodgkin lymphoma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (alternative medicine procedure)
Arm Type
Experimental
Arm 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).
Arm Title
Arm II (alternative medicine procedure)
Arm Type
Sham Comparator
Arm Description
Patients undergo electroacupuncture therapy to sham points on the arms and legs as in arm I.
Intervention Type
Procedure
Intervention Name(s)
electroacupuncture therapy
Intervention Type
Procedure
Intervention Name(s)
sham intervention
Intervention Description
Undergo electroacupuncture therapy to sham points
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Delayed nausea by Marrow Assessment of Nausea and Emesis at 1, 3, and 6 weeks after study completion
Description
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.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Quality of life by QLQ C-30 at 1, 3, and 6 weeks after study completion
Time Frame
Day 8
Title
Pain by Brief Pain Inventory at 1, 3, and 6 weeks after study completion
Description
It is anticipated that Cochran-Armitage trend tests will be used to compare the results between randomized groups.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kara Kelly, MD
Organizational Affiliation
Herbert Irving Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892-1182
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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