Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00046891
Status:
COMPLETED
Last Update Posted:
2016-07-06
First Post:
2002-10-03
Brief Title:
EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
The Use of Ginkgo Biloba For The Prevention Of Chemotherapy-Related Cognitive Dysfunction
Status:
COMPLETED
Status Verified Date:
2016-07
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 Chemotherapy may cause memory loss attention loss and other problems that make it difficult for patients to think clearly EGb761 may help maintain mental clarity in patients undergoing chemotherapy
PURPOSE Randomized clinical trial to study the effectiveness of EGb761 in preventing loss of mental clarity in women who are receiving chemotherapy for newly diagnosed breast cancer
PURPOSE Randomized clinical trial to study the effectiveness of EGb761 in preventing loss of mental clarity in women who are receiving chemotherapy for newly diagnosed breast cancer
Detailed Description:
OBJECTIVES
Determine the effectiveness of EGb761 in the prevention of chemotherapy-related cognitive dysfunction in women with breast cancer
Determine the safety and tolerability of this drug when administered during adjuvant chemotherapy in these patients
Assess the onset and trajectory of cognitive loss that may occur during chemotherapy in these patients
Assess the quality of life and cognitive role functioning of patients treated with this drug
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to type of chemotherapy doxorubicincyclophosphamide vs doxorubicincyclophosphamide with taxane vs other anthracycline-based chemotherapy vs other non-anthracycline-based chemotherapy age 18 to 49 vs 50 and over menopausal status at start of therapy premenopausal vs postmenopausal vs unknown for surgical reasons and lymph node involvement 0-3 vs 4 or more Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral EGb761 twice daily
Arm II Patients receive oral placebo twice daily Patients in both arms receive treatment beginning no later than the start of the second course of chemotherapy and continuing until 1 month after the completion of chemotherapy
Quality of life and cognitive function are assessed at baseline monthly during chemotherapy and then at 1 6 12 18 and 24 months
Patients are followed every 6 months for 2 years
PROJECTED ACCRUAL A total of 220 patients 110 per treatment arm will be accrued for this study within 11 months
Determine the effectiveness of EGb761 in the prevention of chemotherapy-related cognitive dysfunction in women with breast cancer
Determine the safety and tolerability of this drug when administered during adjuvant chemotherapy in these patients
Assess the onset and trajectory of cognitive loss that may occur during chemotherapy in these patients
Assess the quality of life and cognitive role functioning of patients treated with this drug
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to type of chemotherapy doxorubicincyclophosphamide vs doxorubicincyclophosphamide with taxane vs other anthracycline-based chemotherapy vs other non-anthracycline-based chemotherapy age 18 to 49 vs 50 and over menopausal status at start of therapy premenopausal vs postmenopausal vs unknown for surgical reasons and lymph node involvement 0-3 vs 4 or more Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive oral EGb761 twice daily
Arm II Patients receive oral placebo twice daily Patients in both arms receive treatment beginning no later than the start of the second course of chemotherapy and continuing until 1 month after the completion of chemotherapy
Quality of life and cognitive function are assessed at baseline monthly during chemotherapy and then at 1 6 12 18 and 24 months
Patients are followed every 6 months for 2 years
PROJECTED ACCRUAL A total of 220 patients 110 per treatment arm will be accrued for this study within 11 months
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 |
|---|---|---|---|
| CDR0000257008 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02492 | REGISTRY | None | None |
| NCI-P02-0231 | None | None | None |