Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information
Registry Information

Alternate Title

EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Supportive care Closed 18 and over NCI NCCTG-N00C9 NCI-P02-0231, NCT00046891

Objectives

1. Determine the effectiveness of EGb761 in the prevention of chemotherapy-related cognitive dysfunction in women with breast cancer.
2. Determine the safety and tolerability of this drug when administered during adjuvant chemotherapy in these patients.
3. Assess the onset and trajectory of cognitive loss that may occur during chemotherapy in these patients.
4. Assess the quality of life and cognitive role functioning of patients treated with this drug.

Entry Criteria

Disease Characteristics:

• Newly diagnosed breast cancer



• Planned standard doses of adjuvant chemotherapy with or without a taxane



• Hormone receptor status:
  • Not specified

Prior/Concurrent Therapy:

Biologic therapy

• No concurrent stem cell transplantation

Chemotherapy

• See Disease Characteristics
• No concurrent high-dose chemotherapy

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• More than 6 months since prior EGb761
• No concurrent antithrombotic therapy (e.g., daily aspirin or anticoagulants)
  • Anticoagulants used for central or peripheral line maintenance (i.e., warfarin 1 mg/day or heparin flushes) allowed
• No concurrent dose-intensive regimens
• No concurrent aspirin or aspirin-like medicines (e.g., indomethacin, ibuprofen, or some antihistamines or heparin or warfarin [except as used above])
• No concurrent regimen expected to cause thrombocytopenia
• No concurrent trazodone, monoamine oxidase inhibitors, or thiazide diuretics (e.g., chlorothiazide, hydrochlorothiazide, indapamide, or metolazone)

Patient Characteristics:

Age

• 18 and over

Sex

• Female

Menopausal status

• Any status

Performance status

• ECOG 0-1

Life expectancy

• At least 6 months

Hematopoietic

• No bleeding diathesis

Hepatic

• SGOT no greater than 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase no greater than 1.5 times ULN

Renal

• Creatinine no greater than 1.5 times ULN

Cardiovascular

• No arterial vascular disease

Other

• Able to complete questionnaires alone or with assistance
• No diabetes
• No dementia
• No diagnosis of a psychiatric disorder within the past 5 years that would preclude study compliance
• No other significant comorbidity
• No known allergy to ginkgo biloba
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

Expected Enrollment

A total of 220 patients (110 per treatment arm) will be accrued for this study within 11 months.

Outline

This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to type of chemotherapy (doxorubicin/cyclophosphamide vs doxorubicin/cyclophosphamide 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.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Debra Barton, RN, PhD, AOCN, Protocol chair		Ph: 507-538-7623 Email: cancerclinicaltrials@mayo.edu

Registry Information
Official Title		The Use of Ginkgo Biloba For The Prevention Of Chemotherapy-Related Cognitive Dysfunction
Trial Start Date		2002-12-04
Registered in ClinicalTrials.gov		NCT00046891
Date Submitted to PDQ		2002-08-02
Information Last Verified		2007-01-08

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