Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00409071
Status:
COMPLETED
Last Update Posted:
2010-02-05
First Post:
2006-12-07
Brief Title:
Placebo-controlled Evaluation of Cocculine Efficacy in the Management of Nausea After Chemotherapy in Breast Cancer
Sponsor:
Centre Leon Berard
Organization:
Centre Leon Berard
Study Overview
Official Title:
Placebo-controlled Evaluation of Homeopathic Remedy Cocculine Efficacy in the Management of Nausea After Adjuvant Chemotherapy in Non Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2010-02
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:
The purpose of the study is to determine whether a homeopathic remedy Cocculine is effective in the prevention of chemotherapy-induced nausea in non metastatic breast cancer
Eligible patients will be randomly assigned to one of 2-arms Cocculine or placebo
The number of patients required to demonstrate a 05-point reduction in nausea on a visual analogue scale assuming an alpha risk of 5 in a two-sided test and 85 power is 396 198 per arm It has been estimated that the enrollment period should be 18 months
Eligible patients will be randomly assigned to one of 2-arms Cocculine or placebo
The number of patients required to demonstrate a 05-point reduction in nausea on a visual analogue scale assuming an alpha risk of 5 in a two-sided test and 85 power is 396 198 per arm It has been estimated that the enrollment period should be 18 months
Detailed Description:
The proportion of women with breast cancer treated by chemotherapy CT is increasing CT-induced nausea and vomiting negatively impact patient quality of life
The primary objective of the trial is to evaluate against a placebo the efficacy of Cocculine administered as an adjunct to conventional treatments corticosteroids and 5-HT3 receptor antagonists for the management of nausea induced by a 1st course of adjuvant CT with FAC50 FEC100 or TAC in patients with non-metastatic breast cancer
Secondary objectives are to test
the persistence of Cocculine efficacy over the 2nd and 3rd CT courses
the contribution of Cocculine to the global management of nausea and vomiting during adjuvant CT
patient compliance with Cocculine dose
Eligible patients will be randomly assigned to one of 2 arms Cocculine or placebo
The primary objective of the trial is to evaluate against a placebo the efficacy of Cocculine administered as an adjunct to conventional treatments corticosteroids and 5-HT3 receptor antagonists for the management of nausea induced by a 1st course of adjuvant CT with FAC50 FEC100 or TAC in patients with non-metastatic breast cancer
Secondary objectives are to test
the persistence of Cocculine efficacy over the 2nd and 3rd CT courses
the contribution of Cocculine to the global management of nausea and vomiting during adjuvant CT
patient compliance with Cocculine dose
Eligible patients will be randomly assigned to one of 2 arms Cocculine or placebo
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 |
|---|---|---|---|
| ET2005-028 | None | None | None |