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.

View Full Description

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.

View Eligibility Criteria

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)

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

226

Study ID:

NCT00046891

Recruitment Status:

Completed

Sponsor:

Alliance for Clinical Trials in Oncology

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There are 136 Locations for this study

See Locations Near You

Mayo Clinic Scottsdale
Scottsdale Arizona, 85259, United States
Santa Barbara Hematology Oncology - Lompoc
Lompoc California, 93438, United States
Sansum Medical Clinic
Santa Barbara California, 93105, United States
Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara
Santa Barbara California, 93105, United States
Cancer Center of Santa Barbara
Snata Barbara California, 93105, United States
Santa Barbara Hematology Oncology - Solvang
Solvang California, 93463, United States
Aurora Presbyterian Hospital
Aurora Colorado, 80012, United States
Boulder Community Hospital
Boulder Colorado, 80301, United States
Penrose Cancer Center at Penrose Hospital
Colorado Springs Colorado, 80933, United States
Porter Adventist Hospital
Denver Colorado, 80210, United States
Presbyterian - St. Luke's Medical Center
Denver Colorado, 80218, United States
St. Joseph Hospital
Denver Colorado, 80218, United States
Rose Medical Center
Denver Colorado, 80220, United States
CCOP - Colorado Cancer Research Program, Incorporated
Denver Colorado, 80224, United States
Swedish Medical Center
Englewood Colorado, 80110, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction Colorado, 81502, United States
Sky Ridge Medical Center
Lone Tree Colorado, 80124, United States
Hope Cancer Care Center at Longmont United Hospital
Longmont Colorado, 80502, United States
St. Mary-Corwin Regional Medical Center
Pueblo Colorado, 81004, United States
North Suburban Medical Center
Thornton Colorado, 80229, United States
Mayo Clinic - Jacksonville
Jacksonville Florida, 32224, United States
Piedmont Hospital
Atlanta Georgia, 30309, United States
Northside Hospital Cancer Center
Atlanta Georgia, 30342, United States
Saint Joseph's Hospital of Atlanta
Atlanta Georgia, 30342, United States
CCOP - Atlanta Regional
Atlanta Georgia, 30342, United States
MBCCOP - Medical College of Georgia Cancer Center
Augusta Georgia, 30912, United States
WellStar Cobb Hospital
Austell Georgia, 30106, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur Georgia, 30033, United States
Gwinnett Medical Center
Lawrenceville Georgia, 30045, United States
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta Georgia, 30060, United States
Southern Regional Medical Center
Riverdale Georgia, 30274, United States
Rush-Copley Cancer Care Center
Aurora Illinois, 60507, United States
Graham Hospital
Canton Illinois, 61520, United States
Memorial Hospital
Carthage Illinois, 62321, United States
Eureka Community Hospital
Eureka Illinois, 61530, United States
Galesburg Clinic
Galesburg Illinois, 61401, United States
Galesburg Cottage Hospital
Galesburg Illinois, 61401, United States
Mason District Hospital
Havana Illinois, 62644, United States
Hopedale Medical Complex
Hopedale Illinois, 61747, United States
Joliet Oncology-Hematology Associates, Limited - West
Joliet Illinois, 60435, United States
Kewanee Hospital
Kewanee Illinois, 61443, United States
McDonough District Hospital
Macomb Illinois, 61455, United States
Trinity Medical Center - East
Moline Illinois, 61265, United States

Moline Illinois, 61265, United States
BroMenn Regional Medical Center
Normal Illinois, 61761, United States
Community Cancer Center
Normal Illinois, 61761, United States
Community Hospital of Ottawa
Ottawa Illinois, 61350, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa Illinois, 61350, United States
Cancer Treatment Center at Pekin Hospital
Pekin Illinois, 61554, United States
Proctor Hospital
Peoria Illinois, 61614, United States
CCOP - Illinois Oncology Research Association
Peoria Illinois, 61615, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria Illinois, 61636, United States
Illinois Valley Community Hospital
Peru Illinois, 61354, United States
St. Margaret's Hospital
Spring Valley Illinois, 61362, United States
Carle Cancer Center at Carle Foundation Hospital
Urbana Illinois, 61801, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Saint Anthony Memorial Health Centers
Michigan City Indiana, 46360, United States
McFarland Clinic, PC
Ames Iowa, 50010, United States

Bettendorf Iowa, 52722, United States
St. Luke's Hospital
Cedar Rapids Iowa, 52402, United States
Cedar Rapids Oncology Associates
Cedar Rapids Iowa, 52403, United States
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids Iowa, 52403, United States
Mercy Capitol Hospital
Des Moines Iowa, 50307, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines Iowa, 50314, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines Iowa, 50316, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City Iowa, 50401, United States
Ottumwa Regional Health Center Cancer Center
Ottumwa Iowa, 52501, United States
Siouxland Hematology-Oncology Associates, LLP
Sioux City Iowa, 51101, United States
Siouxland Regional Cancer Center
Sioux City Iowa, 51101, United States
Mercy Medical Center - Sioux City
Sioux City Iowa, 51104, United States
St. Luke's Regional Medical Center
Sioux City Iowa, 51104, United States
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines Iowa, 50266, United States
Cancer Center of Kansas, PA - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado Kansas, 67042, United States
Cancer Center of Kansas, PA - Kingman
Kingman Kansas, 67068, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina Kansas, 67042, United States
Cancer Center of Kansas, PA - Wellington
Wellington Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita Kansas, 67203, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita Kansas, 67214, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield Kansas, 67156, United States
Ochsner Clinic of Baton Rouge
Baton Rouge Louisiana, 70816, United States
Terrebonne General Medical Center
Houma Louisiana, 70360, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans Louisiana, 70121, United States
Hickman Cancer Center at Bixby Medical Center
Adrian Michigan, 49221, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan, 48106, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn Michigan, 48123, United States
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States
Hurley Medical Center
Flint Michigan, 48503, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods Michigan, 48236, United States
Foote Hospital
Jackson Michigan, 49201, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville Michigan, 48144, United States
Sparrow Regional Cancer Center
Lansing Michigan, 48909, United States
Community Cancer Center of Monroe
Monroe Michigan, 48162, United States
Mercy Memorial Hospital System
Monroe Michigan, 48162, United States
Seton Cancer Institute - Saginaw
Saginaw Michigan, 48601, United States
St. John Macomb Hospital
Warren Michigan, 48093, United States

Alexandria Minnesota, 56308, United States
MeritCare Clinic - Bemidji
Bemidji Minnesota, 56601, United States
Brainerd Medical Center
Brainerd Minnesota, 56401, United States
St. Joseph's Medical Center
Brainerd Minnesota, 56401, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Miller-Dwan Medical Center
Duluth Minnesota, 55805, United States
St. Mary's - Duluth Clinic Cancer Center
Duluth Minnesota, 55805, United States

Fergus Falls Minnesota, 56537, United States
Immanuel St. Joseph's Clinic
Mankato Minnesota, 56002, United States
Chippewa County - Montevideo Hospital
Montevideo Minnesota, 56265, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
Coborn Cancer Center
Saint Cloud Minnesota, 56303, United States
Adult and Pediatric Urology, P.L.L.P.
Sartell Minnesota, 56377, United States
CentraCare Clinic - River Campus
St. Cloud Minnesota, 56303, United States
Hattiesburg Clinic, PA at Forrest General
Hattiesburg Mississippi, 39401, United States
Hematology & Oncology Clinic
Hattiesburg Mississippi, 39402, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings Montana, 59101, United States
St. Vincent Healthcare
Billings Montana, 59101, United States
Deaconess Billings Clinic - Downtown
Billings Montana, 59107, United States
Bozeman Deaconess Hospital
Bozeman Montana, 59715, United States
St. James Community Hospital
Butte Montana, 59701, United States
Great Falls Clinic
Great Falls Montana, 59405, United States
St. Peter's Hospital
Helena Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell Montana, 59901, United States
Kalispell Medical Oncology
Kalispell Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States
Community Medical Center
Missoula Montana, 59801, United States
Clinic of Dr. Judy L. Schmidt
Missoula Montana, 59804, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula Montana, 59807, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula Montana, 59807, United States
Cancer Resource Center - Lincoln
Lincoln Nebraska, 68510, United States
CCOP - Missouri Valley Cancer Consortium
Omaha Nebraska, 68106, United States
Immanuel Medical Center
Omaha Nebraska, 68122, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha Nebraska, 68124, United States
Creighton University Medical Center
Omaha Nebraska, 68131, United States
CCOP - MeritCare Hospital
Fargo North Dakota, 58122, United States
MeritCare Medical Group
Fargo North Dakota, 58122, United States
Wood County Oncology Center
Bowling Green Ohio, 43402, United States
Blanchard Valley Medical Associates
Findlay Ohio, 45840, United States
Fremont Memorial Hospital
Fremont Ohio, 43420, United States
Kenton Oncology, Incorporated
Kenton Ohio, 43326, United States
Lima Memorial Hospital
Lima Ohio, 45804, United States
Northwest Ohio Oncology Center
Maumee Ohio, 43537, United States
St. Luke's Hospital
Maumee Ohio, 43537, United States
St. Charles Mercy Hospital
Oregon Ohio, 43616, United States
Toledo Clinic - Oregon
Oregon Ohio, 43616, United States
Firelands Regional Medical Center
Sandusky Ohio, 44870, United States
North Coast Cancer Care, Incorporated
Sandusky Ohio, 44870, United States
Flower Hospital Cancer Center
Sylvania Ohio, 43560, United States
Mercy Hospital of Tiffin
Tiffin Ohio, 44883, United States
Toledo Hospital
Toledo Ohio, 43606, United States
St. Vincent Mercy Medical Center
Toledo Ohio, 43608, United States
Medical University of Ohio Cancer Center
Toledo Ohio, 43614, United States
CCOP - Toledo Community Hospital
Toledo Ohio, 43623, United States
Toledo Clinic, Incorporated - Main Clinic
Toledo Ohio, 43623, United States
Fulton County Health Center
Wauseon Ohio, 43567, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown Pennsylvania, 18105, United States
Rapid City Regional Hospital
Rapid City South Dakota, 57701, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Medical X-Ray Center, PC
Sioux Falls South Dakota, 57105, United States
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls South Dakota, 57117, United States
Franciscan Skemp Healthcare
La Crosse Wisconsin, 54601, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan Wyoming, 82801, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

226

Study ID:

NCT00046891

Recruitment Status:

Completed

Sponsor:


Alliance for Clinical Trials in Oncology

How clear is this clinincal trial information?

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