Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00065221
Status:
COMPLETED
Last Update Posted:
2008-01-25
First Post:
2003-07-18
Brief Title:
Ginger Control of Chemotherapy Induced Nausea and Vomiting
Sponsor:
National Center for Complementary and Integrative Health NCCIH
Organization:
National Center for Complementary and Integrative Health NCCIH
Study Overview
Official Title:
Trial of Encapsulated Ginger as a Treatment for Chemotherapy-Induced Nausea and Vomiting
Status:
COMPLETED
Status Verified Date:
2008-01
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:
This is a trial to determine the safety and efficacy of ginger in reducing the prevalence and severity of chemotherapy induced nausea and vomiting
Detailed Description:
Chemotherapy induced nausea and vomiting significantly reduces patients quality of life increases fatigue anxiety and increases costs of health care delivery Ginger Zingiber officinalis is already used in traditional folk medicine to treat nausea and vomiting in various populations Gingers ability to block 5-HT3 receptors and its free-radical scavenging in the intestines suggest that it may be beneficial for reducing both the prevalence and severity of chemotherapy induced nausea and vomiting Despite gingers possible benefits in reducing the prevalence and severity of chemotherapy induced nausea and vomiting no dosing andor safety studies have been performed
This study will assess the efficacy and safety of two dose levels 1000 mg or 2000 mg orallyday of Zingiber officinalis extract standardized for 5 gingerols in patients undergoing chemotherapy cisplastin or adriamycin who have experienced at least one episode of chemotherapy induced nausea and vomiting despite optimal conventional medical therapy The primary aim of the study is to determine the most efficacious dose of powdered ginger-root for reducing the prevalence and severity of acute nausea and vomiting Secondary aims of the study include 1 determination of the most efficacious dose of powdered ginger-root for reducing the prevalence and severity of delayed nausea and vomiting 2 assessment of the safety of different doses of oral powdered ginger root in patients receiving chemotherapy and 3 determination if study participants can discern if they are receiving placebo or ginger Participants receiving either adriamycin or cisplatin for cancer related treatment will be randomized to receive one of two doses of powdered ginger or placebo immediately prior to chemotherapy infusion Participants will be followed for 72 hours after infusion in order to assess frequency and severity of nausea and vomiting Baseline and 72 hour post chemotherapy labs will be used to assess safety profile of ginger
This study will assess the efficacy and safety of two dose levels 1000 mg or 2000 mg orallyday of Zingiber officinalis extract standardized for 5 gingerols in patients undergoing chemotherapy cisplastin or adriamycin who have experienced at least one episode of chemotherapy induced nausea and vomiting despite optimal conventional medical therapy The primary aim of the study is to determine the most efficacious dose of powdered ginger-root for reducing the prevalence and severity of acute nausea and vomiting Secondary aims of the study include 1 determination of the most efficacious dose of powdered ginger-root for reducing the prevalence and severity of delayed nausea and vomiting 2 assessment of the safety of different doses of oral powdered ginger root in patients receiving chemotherapy and 3 determination if study participants can discern if they are receiving placebo or ginger Participants receiving either adriamycin or cisplatin for cancer related treatment will be randomized to receive one of two doses of powdered ginger or placebo immediately prior to chemotherapy infusion Participants will be followed for 72 hours after infusion in order to assess frequency and severity of nausea and vomiting Baseline and 72 hour post chemotherapy labs will be used to assess safety profile of ginger
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