Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00040911
Status:
COMPLETED
Last Update Posted:
2013-05-31
First Post:
2002-07-08
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
Sponsor:
Childrens Oncology Group
Organization:
Childrens Oncology Group
Study Overview
Official Title:
A Randomized Study Of Electroacupuncture Treatment For Delayed Chemotherapy-Induced Nausea And Vomiting In Patients With Pediatric Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 25-3 years
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 25-3 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCCAM-02-AT-0172 | None | None | None |
| NCI-02-AT-0172 | OTHER | None | None |
| COG-ACCL04C2 | OTHER | None | None |
| CDR0000069419 | OTHER | Clinical Trialsgov | None |