Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060021
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2003-05-06
Brief Title:
Acupuncture in Treating Mucositis-Related Pain Caused by Chemotherapy in Patients Undergoing Stem Cell Transplantation
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Randomized Placebo-Controlled Blinded Study Of Acupuncture Therapy In Mucositis-Related Pain In Patients Undergoing Hematopoietic Stem Cell Transplantation
Status:
COMPLETED
Status Verified Date:
2004-04
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 Acupuncture may be effective in relieving mucositis-related pain caused by chemotherapy in patients undergoing stem cell transplantation
PURPOSE Randomized clinical trial to study the effectiveness of acupuncture in treating mucositis-related pain caused by high-dose chemotherapy in patients who are undergoing stem cell transplantation
PURPOSE Randomized clinical trial to study the effectiveness of acupuncture in treating mucositis-related pain caused by high-dose chemotherapy in patients who are undergoing stem cell transplantation
Detailed Description:
OBJECTIVES
Compare the efficacy of acupuncture vs placebo acupuncture in alleviating mucositis-related pain secondary to high-dose chemotherapy as assessed by total cumulative dose of opioids used and subjective pain scores in patients undergoing hematopoietic stem cell transplantation
Compare the overall number of patients requiring opioid therapy in these 2 intervention groups
Compare the nausea and vomiting scores of patients in these 2 intervention groups
Compare the sedation score of patients in these 2 intervention groups
Compare the use of other psychotropic medications eg anxiolytics or hypnotics in patients in these 2 intervention groups
Compare the need for total parenteral nutrition TPN and the number of days on TPN experienced by patients in these 2 intervention groups
Compare pruritus and the need for symptomatic treatment in patients in these 2 intervention groups
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to 9-phenylthiocarbamide6-n-propylthiouracil PROP tasting ability super-tasters vs non-super-tasters Patients are randomized to 1 of 2 treatment arms
Arm I Beginning immediately after the development of mucositis pain patients undergo acupuncture over 30 minutes once daily Patients also receive standard pain management Treatment continues until pain is completely resolved in the absence of unacceptable toxicity
Arm II Patients undergo placebo acupuncture and receive standard pain management as in arm I
PROJECTED ACCRUAL A maximum of 45 patients will be accrued for this study within 3 years
Compare the efficacy of acupuncture vs placebo acupuncture in alleviating mucositis-related pain secondary to high-dose chemotherapy as assessed by total cumulative dose of opioids used and subjective pain scores in patients undergoing hematopoietic stem cell transplantation
Compare the overall number of patients requiring opioid therapy in these 2 intervention groups
Compare the nausea and vomiting scores of patients in these 2 intervention groups
Compare the sedation score of patients in these 2 intervention groups
Compare the use of other psychotropic medications eg anxiolytics or hypnotics in patients in these 2 intervention groups
Compare the need for total parenteral nutrition TPN and the number of days on TPN experienced by patients in these 2 intervention groups
Compare pruritus and the need for symptomatic treatment in patients in these 2 intervention groups
OUTLINE This is a randomized double-blind placebo-controlled study Patients are stratified according to 9-phenylthiocarbamide6-n-propylthiouracil PROP tasting ability super-tasters vs non-super-tasters Patients are randomized to 1 of 2 treatment arms
Arm I Beginning immediately after the development of mucositis pain patients undergo acupuncture over 30 minutes once daily Patients also receive standard pain management Treatment continues until pain is completely resolved in the absence of unacceptable toxicity
Arm II Patients undergo placebo acupuncture and receive standard pain management as in arm I
PROJECTED ACCRUAL A maximum of 45 patients will be accrued for this study within 3 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-03-C-0125 | None | None | None |