EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer
Breast Cancer, Neurotoxicity
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring neurotoxicity, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
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)
Sites / Locations
- Mayo Clinic Scottsdale
- Santa Barbara Hematology Oncology - Lompoc
- Sansum Medical Clinic
- Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara
- Cancer Center of Santa Barbara
- Santa Barbara Hematology Oncology - Solvang
- Aurora Presbyterian Hospital
- Boulder Community Hospital
- Penrose Cancer Center at Penrose Hospital
- Porter Adventist Hospital
- Presbyterian - St. Luke's Medical Center
- St. Joseph Hospital
- Rose Medical Center
- CCOP - Colorado Cancer Research Program, Incorporated
- Swedish Medical Center
- St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
- Sky Ridge Medical Center
- Hope Cancer Care Center at Longmont United Hospital
- St. Mary-Corwin Regional Medical Center
- North Suburban Medical Center
- Mayo Clinic - Jacksonville
- Piedmont Hospital
- Northside Hospital Cancer Center
- Saint Joseph's Hospital of Atlanta
- CCOP - Atlanta Regional
- MBCCOP - Medical College of Georgia Cancer Center
- WellStar Cobb Hospital
- Charles B. Eberhart Cancer Center at DeKalb Medical Center
- Gwinnett Medical Center
- Kennestone Cancer Center at Wellstar Kennestone Hospital
- Southern Regional Medical Center
- Rush-Copley Cancer Care Center
- Graham Hospital
- Memorial Hospital
- Eureka Community Hospital
- Galesburg Clinic
- Galesburg Cottage Hospital
- Mason District Hospital
- Hopedale Medical Complex
- Joliet Oncology-Hematology Associates, Limited - West
- Kewanee Hospital
- McDonough District Hospital
- Trinity Medical Center - East
- BroMenn Regional Medical Center
- Community Cancer Center
- Community Hospital of Ottawa
- Oncology Hematology Associates of Central Illinois, PC - Ottawa
- Cancer Treatment Center at Pekin Hospital
- Proctor Hospital
- CCOP - Illinois Oncology Research Association
- Oncology Hematology Associates of Central Illinois, PC - Peoria
- Methodist Medical Center of Illinois
- Illinois Valley Community Hospital
- St. Margaret's Hospital
- Carle Cancer Center at Carle Foundation Hospital
- CCOP - Carle Cancer Center
- Saint Anthony Memorial Health Centers
- McFarland Clinic, PC
- St. Luke's Hospital
- Cedar Rapids Oncology Associates
- Mercy Regional Cancer Center at Mercy Medical Center
- Mercy Capitol Hospital
- CCOP - Iowa Oncology Research Association
- John Stoddard Cancer Center at Iowa Methodist Medical Center
- Medical Oncology and Hematology Associates at John Stoddard Cancer Center
- Medical Oncology and Hematology Associates at Mercy Cancer Center
- Mercy Cancer Center at Mercy Medical Center - Des Moines
- John Stoddard Cancer Center at Iowa Lutheran Hospital
- Mercy Cancer Center at Mercy Medical Center - North Iowa
- Ottumwa Regional Health Center Cancer Center
- Siouxland Hematology-Oncology Associates, LLP
- Siouxland Regional Cancer Center
- Mercy Medical Center - Sioux City
- St. Luke's Regional Medical Center
- Medical Oncology and Hematology Associates - West Des Moines
- Cancer Center of Kansas, PA - Chanute
- Cancer Center of Kansas, PA - Dodge City
- Cancer Center of Kansas, PA - El Dorado
- Cancer Center of Kansas, PA - Kingman
- Southwest Medical Center
- Cancer Center of Kansas, PA - Newton
- Cancer Center of Kansas, PA - Parsons
- Cancer Center of Kansas, PA - Pratt
- Cancer Center of Kansas, PA - Salina
- Cancer Center of Kansas, PA - Wellington
- Associates in Womens Health, PA - North Review
- Cancer Center of Kansas, PA - Medical Arts Tower
- Cancer Center of Kansas, PA - Wichita
- CCOP - Wichita
- Via Christi Cancer Center at Via Christi Regional Medical Center
- Cancer Center of Kansas, PA - Winfield
- Ochsner Clinic of Baton Rouge
- Terrebonne General Medical Center
- Ochsner Cancer Institute at Ochsner Clinic Foundation
- Hickman Cancer Center at Bixby Medical Center
- St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
- CCOP - Michigan Cancer Research Consortium
- Oakwood Cancer Center at Oakwood Hospital and Medical Center
- Genesys Hurley Cancer Institute
- Hurley Medical Center
- Van Elslander Cancer Center at St. John Hospital and Medical Center
- Foote Hospital
- Haematology-Oncology Associates of Ohio and Michigan, PC
- Sparrow Regional Cancer Center
- Community Cancer Center of Monroe
- Mercy Memorial Hospital System
- Seton Cancer Institute - Saginaw
- St. John Macomb Hospital
- MeritCare Clinic - Bemidji
- Brainerd Medical Center
- St. Joseph's Medical Center
- CCOP - Duluth
- Miller-Dwan Medical Center
- St. Mary's - Duluth Clinic Cancer Center
- Immanuel St. Joseph's Clinic
- Chippewa County - Montevideo Hospital
- Mayo Clinic Cancer Center
- Coborn Cancer Center
- Adult and Pediatric Urology, P.L.L.P.
- CentraCare Clinic - River Campus
- Hattiesburg Clinic, PA at Forrest General
- Hematology & Oncology Clinic
- CCOP - Montana Cancer Consortium
- Hematology-Oncology Centers of the Northern Rockies - Billings
- Northern Rockies Radiation Oncology Center
- St. Vincent Healthcare
- Deaconess Billings Clinic - Downtown
- Bozeman Deaconess Hospital
- St. James Community Hospital
- Great Falls Clinic
- St. Peter's Hospital
- Glacier Oncology, PLLC
- Kalispell Medical Oncology
- Kalispell Regional Medical Center
- Community Medical Center
- Clinic of Dr. Judy L. Schmidt
- Montana Cancer Specialists at Montana Cancer Center
- Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
- Cancer Resource Center - Lincoln
- CCOP - Missouri Valley Cancer Consortium
- Immanuel Medical Center
- Alegant Health Cancer Center at Bergan Mercy Medical Center
- Creighton University Medical Center
- CCOP - MeritCare Hospital
- MeritCare Medical Group
- Wood County Oncology Center
- Blanchard Valley Medical Associates
- Fremont Memorial Hospital
- Kenton Oncology, Incorporated
- Lima Memorial Hospital
- Northwest Ohio Oncology Center
- St. Luke's Hospital
- St. Charles Mercy Hospital
- Toledo Clinic - Oregon
- Firelands Regional Medical Center
- North Coast Cancer Care, Incorporated
- Flower Hospital Cancer Center
- Mercy Hospital of Tiffin
- Toledo Hospital
- St. Vincent Mercy Medical Center
- Medical University of Ohio Cancer Center
- CCOP - Toledo Community Hospital
- Toledo Clinic, Incorporated - Main Clinic
- Fulton County Health Center
- Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
- Rapid City Regional Hospital
- Avera Cancer Institute
- Medical X-Ray Center, PC
- Sioux Valley Hospital and University of South Dakota Medical Center
- Franciscan Skemp Healthcare
- Welch Cancer Center at Sheridan Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Ginkgo Biloba
Placebo
120 mg per day (60 mg BID)
1 tablet BID