Breast Cancer Clinical Trial
EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer
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.
Full 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 (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.
PROJECTED ACCRUAL: A total of 220 patients (110 per treatment arm) will be accrued for this study within 11 months.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Newly diagnosed breast cancer
Planned standard doses of adjuvant chemotherapy with or without a taxane
PATIENT CHARACTERISTICS:
Age
18 and over
Sex
Female
Menopausal status
Any status
Performance status
Eastern Cooperative Oncology Group (ECOG) 0-1
Life expectancy
At least 6 months
Hematopoietic
No bleeding diathesis
Hepatic
serum glutamate oxaloacetate transaminase (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
PRIOR CONCURRENT THERAPY:
Biologic therapy
No concurrent stem cell transplantation
Chemotherapy
No concurrent high-dose chemotherapy
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)
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There are 136 Locations for this study
Scottsdale Arizona, 85259, United States
Lompoc California, 93438, United States
Santa Barbara California, 93105, United States
Santa Barbara California, 93105, United States
Snata Barbara California, 93105, United States
Solvang California, 93463, United States
Aurora Colorado, 80012, United States
Boulder Colorado, 80301, United States
Colorado Springs Colorado, 80933, United States
Denver Colorado, 80210, United States
Denver Colorado, 80218, United States
Denver Colorado, 80218, United States
Denver Colorado, 80220, United States
Denver Colorado, 80224, United States
Englewood Colorado, 80110, United States
Grand Junction Colorado, 81502, United States
Lone Tree Colorado, 80124, United States
Longmont Colorado, 80502, United States
Pueblo Colorado, 81004, United States
Thornton Colorado, 80229, United States
Jacksonville Florida, 32224, United States
Atlanta Georgia, 30309, United States
Atlanta Georgia, 30342, United States
Atlanta Georgia, 30342, United States
Atlanta Georgia, 30342, United States
Augusta Georgia, 30912, United States
Austell Georgia, 30106, United States
Decatur Georgia, 30033, United States
Lawrenceville Georgia, 30045, United States
Marietta Georgia, 30060, United States
Riverdale Georgia, 30274, United States
Aurora Illinois, 60507, United States
Canton Illinois, 61520, United States
Carthage Illinois, 62321, United States
Eureka Illinois, 61530, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Havana Illinois, 62644, United States
Hopedale Illinois, 61747, United States
Joliet Illinois, 60435, United States
Kewanee Illinois, 61443, United States
Macomb Illinois, 61455, United States
Moline Illinois, 61265, United States
Moline Illinois, 61265, United States
Normal Illinois, 61761, United States
Normal Illinois, 61761, United States
Ottawa Illinois, 61350, United States
Ottawa Illinois, 61350, United States
Pekin Illinois, 61554, United States
Peoria Illinois, 61614, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61636, United States
Peru Illinois, 61354, United States
Spring Valley Illinois, 61362, United States
Urbana Illinois, 61801, United States
Urbana Illinois, 61801, United States
Michigan City Indiana, 46360, United States
Ames Iowa, 50010, United States
Bettendorf Iowa, 52722, United States
Cedar Rapids Iowa, 52402, United States
Cedar Rapids Iowa, 52403, United States
Cedar Rapids Iowa, 52403, United States
Des Moines Iowa, 50307, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
Mason City Iowa, 50401, United States
Ottumwa Iowa, 52501, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51104, United States
Sioux City Iowa, 51104, United States
West Des Moines Iowa, 50266, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Kingman Kansas, 67068, United States
Liberal Kansas, 67901, United States
Newton Kansas, 67114, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67042, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67203, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Baton Rouge Louisiana, 70816, United States
Houma Louisiana, 70360, United States
New Orleans Louisiana, 70121, United States
Adrian Michigan, 49221, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48106, United States
Dearborn Michigan, 48123, United States
Flint Michigan, 48503, United States
Flint Michigan, 48503, United States
Grosse Pointe Woods Michigan, 48236, United States
Jackson Michigan, 49201, United States
Lambertville Michigan, 48144, United States
Lansing Michigan, 48909, United States
Monroe Michigan, 48162, United States
Monroe Michigan, 48162, United States
Saginaw Michigan, 48601, United States
Warren Michigan, 48093, United States
Alexandria Minnesota, 56308, United States
Bemidji Minnesota, 56601, United States
Brainerd Minnesota, 56401, United States
Brainerd Minnesota, 56401, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Duluth Minnesota, 55805, United States
Fergus Falls Minnesota, 56537, United States
Mankato Minnesota, 56002, United States
Montevideo Minnesota, 56265, United States
Rochester Minnesota, 55905, United States
Saint Cloud Minnesota, 56303, United States
Sartell Minnesota, 56377, United States
St. Cloud Minnesota, 56303, United States
Hattiesburg Mississippi, 39401, United States
Hattiesburg Mississippi, 39402, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59107, United States
Bozeman Montana, 59715, United States
Butte Montana, 59701, United States
Great Falls Montana, 59405, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59801, United States
Missoula Montana, 59804, United States
Missoula Montana, 59807, United States
Missoula Montana, 59807, United States
Lincoln Nebraska, 68510, United States
Omaha Nebraska, 68106, United States
Omaha Nebraska, 68122, United States
Omaha Nebraska, 68124, United States
Omaha Nebraska, 68131, United States
Fargo North Dakota, 58122, United States
Fargo North Dakota, 58122, United States
Bowling Green Ohio, 43402, United States
Findlay Ohio, 45840, United States
Fremont Ohio, 43420, United States
Kenton Ohio, 43326, United States
Lima Ohio, 45804, United States
Maumee Ohio, 43537, United States
Maumee Ohio, 43537, United States
Oregon Ohio, 43616, United States
Oregon Ohio, 43616, United States
Sandusky Ohio, 44870, United States
Sandusky Ohio, 44870, United States
Sylvania Ohio, 43560, United States
Tiffin Ohio, 44883, United States
Toledo Ohio, 43606, United States
Toledo Ohio, 43608, United States
Toledo Ohio, 43614, United States
Toledo Ohio, 43623, United States
Toledo Ohio, 43623, United States
Wauseon Ohio, 43567, United States
Allentown Pennsylvania, 18105, United States
Rapid City South Dakota, 57701, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57105, United States
Sioux Falls South Dakota, 57117, United States
La Crosse Wisconsin, 54601, United States
Sheridan Wyoming, 82801, United States
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