The Use of Ginkgo Biloba For The Prevention Of Chemotherapy-Related Cognitive Dysfunction
N/A
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Neurotoxicity
Female
Breast Cancer, Neurotoxicity
Trial Information
The Use of Ginkgo Biloba For The Prevention Of Chemotherapy-Related Cognitive Dysfunction
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Newly diagnosed breast cancer
- Planned standard doses of adjuvant chemotherapy with or without a taxane
- Hormone receptor status:
- Not specified
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
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)
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Principal Investigator
Debra Barton, RN, PhD, AOCN, FAAN
Investigator Role:
Study Chair
Investigator Affiliation:
Mayo Clinic
Authority:
United States: Federal Government
Study ID:
CDR0000257008
NCT ID:
NCT00046891
Start Date:
December 2002
Completion Date:
Related Keywords:
- Breast Cancer
- Neurotoxicity
- neurotoxicity
- stage I breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- Breast Neoplasms
- Neurotoxicity Syndromes
Name | Location |
|---|---|
| Mayo Clinic Scottsdale | Scottsdale, Arizona 85259 |
| Mayo Clinic - Jacksonville | Jacksonville, Florida 32224 |
| Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| Hurley Medical Center | Flint, Michigan 48503 |
| CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
| CCOP - Missouri Valley Cancer Consortium | Omaha, Nebraska 68131 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
| CCOP - Carle Cancer Center | Urbana, Illinois 61801 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| Aurora Presbyterian Hospital | Aurora, Colorado 80012 |
| Boulder Community Hospital | Boulder, Colorado 80301-9019 |
| Penrose Cancer Center at Penrose Hospital | Colorado Springs, Colorado 80933 |
| Porter Adventist Hospital | Denver, Colorado 80210 |
| Presbyterian - St. Luke's Medical Center | Denver, Colorado 80218 |
| St. Joseph Hospital | Denver, Colorado 80218 |
| Rose Medical Center | Denver, Colorado 80220 |
| Swedish Medical Center | Englewood, Colorado 80110 |
| St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction, Colorado 81502 |
| Sky Ridge Medical Center | Lone Tree, Colorado 80124 |
| Hope Cancer Care Center at Longmont United Hospital | Longmont, Colorado 80502 |
| North Suburban Medical Center | Thornton, Colorado 80229 |
| Rush-Copley Cancer Care Center | Aurora, Illinois 60507 |
| Joliet Oncology-Hematology Associates, Limited - West | Joliet, Illinois 60435 |
| Carle Cancer Center at Carle Foundation Hospital | Urbana, Illinois 61801 |
| Saint Anthony Memorial Health Centers | Michigan City, Indiana 46360 |
| Cedar Rapids Oncology Associates | Cedar Rapids, Iowa 52403 |
| Mercy Medical Center - Sioux City | Sioux City, Iowa 51104 |
| Siouxland Hematology-Oncology Associates, LLP | Sioux City, Iowa 51101 |
| St. Luke's Regional Medical Center | Sioux City, Iowa 51104 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
| Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
| Foote Hospital | Jackson, Michigan 49201 |
| Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
| Seton Cancer Institute - Saginaw | Saginaw, Michigan 48601 |
| St. John Macomb Hospital | Warren, Michigan 48093 |
| CCOP - Duluth | Duluth, Minnesota 55805 |
| CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
| Medical X-Ray Center, PC | Sioux Falls, South Dakota 57105 |
| Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
| Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
| Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
| CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
| Hinsdale, Illinois 60521 | |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
| St. Vincent Mercy Medical Center | Toledo, Ohio 43608 |
| CCOP - Colorado Cancer Research Program, Incorporated | Denver, Colorado 80224 |
| Great Falls Clinic | Great Falls, Montana 59405 |
| Northside Hospital Cancer Center | Atlanta, Georgia 30342-1611 |
| Sioux Valley Hospital and University of South Dakota Medical Center | Sioux Falls, South Dakota 57117-5134 |
| CCOP - Toledo Community Hospital | Toledo, Ohio 43623-3456 |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
| Ochsner Cancer Institute at Ochsner Clinic Foundation | New Orleans, Louisiana 70121 |
| Medical University of Ohio Cancer Center | Toledo, Ohio 43614 |
| Toledo Hospital | Toledo, Ohio 43606 |
| St. Mary's - Duluth Clinic Cancer Center | Duluth, Minnesota 55805 |
| Siouxland Regional Cancer Center | Sioux City, Iowa 51101-1733 |
| Southwest Medical Center | Liberal, Kansas 67901 |
| Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
| Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
| St. Vincent Healthcare | Billings, Montana 59101 |
| Deaconess Billings Clinic - Downtown | Billings, Montana 59101 |
| Bozeman Deaconess Hospital | Bozeman, Montana 59715 |
| St. James Community Hospital | Butte, Montana 59701 |
| St. Peter's Hospital | Helena, Montana 59601 |
| Kalispell Medical Oncology | Kalispell, Montana 59901 |
| Kalispell Regional Medical Center | Kalispell, Montana 59901 |
| Glacier Oncology, PLLC | Kalispell, Montana 59901 |
| Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
| Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
| Community Medical Center | Missoula, Montana 59801 |
| MBCCOP - Medical College of Georgia Cancer Center | Augusta, Georgia 30912-3730 |
| Cancer Center of Santa Barbara | Santa Barbara, California 93105 |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
| St. Mary-Corwin Regional Medical Center | Pueblo, Colorado 81004 |
| Saint Joseph's Hospital of Atlanta | Atlanta, Georgia 30342-1701 |
| Piedmont Hospital | Atlanta, Georgia 30309 |
| WellStar Cobb Hospital | Austell, Georgia 30106 |
| Charles B. Eberhart Cancer Center at DeKalb Medical Center | Decatur, Georgia 30033 |
| Gwinnett Medical Center | Lawrenceville, Georgia 30045 |
| Kennestone Cancer Center at Wellstar Kennestone Hospital | Marietta, Georgia 30060 |
| Southern Regional Medical Center | Riverdale, Georgia 30274-2600 |
| Graham Hospital | Canton, Illinois 61520 |
| Memorial Hospital | Carthage, Illinois 62321 |
| Eureka Community Hospital | Eureka, Illinois 61530 |
| Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
| Galesburg Clinic | Galesburg, Illinois 61401 |
| Mason District Hospital | Havana, Illinois 62644 |
| Hopedale Medical Complex | Hopedale, Illinois 61747 |
| Kewanee Hospital | Kewanee, Illinois 61443 |
| McDonough District Hospital | Macomb, Illinois 61455 |
| Trinity Medical Center - East | Moline, Illinois 61265 |
| BroMenn Regional Medical Center | Normal, Illinois 61761 |
| Community Cancer Center | Normal, Illinois 61761 |
| Community Hospital of Ottawa | Ottawa, Illinois 61350 |
| Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa, Illinois 61350 |
| Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
| Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria, Illinois 61615 |
| Proctor Hospital | Peoria, Illinois 61614 |
| Illinois Valley Community Hospital | Peru, Illinois 61354 |
| St. Margaret's Hospital | Spring Valley, Illinois 61362 |
| Bettendorf, Iowa 52722 | |
| St. Luke's Hospital | Cedar Rapids, Iowa 52402 |
| Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids, Iowa 52403 |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
| Mercy Capitol Hospital | Des Moines, Iowa 50307 |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
| Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
| Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
| Ochsner Clinic of Baton Rouge | Baton Rouge, Louisiana 708169990 |
| Terrebonne General Medical Center | Houma, Louisiana 70360 |
| Hickman Cancer Center at Bixby Medical Center | Adrian, Michigan 49221 |
| St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital | Ann Arbor, Michigan 48106-0995 |
| Community Cancer Center of Monroe | Monroe, Michigan 48162 |
| Mercy Memorial Hospital System | Monroe, Michigan 48162 |
| Alexandria, Minnesota 56308 | |
| MeritCare Clinic - Bemidji | Bemidji, Minnesota 56601 |
| Brainerd Medical Center | Brainerd, Minnesota 56401 |
| St. Joseph's Medical Center | Brainerd, Minnesota 56401 |
| Chippewa County - Montevideo Hospital | Montevideo, Minnesota 56265 |
| Coborn Cancer Center | Saint Cloud, Minnesota 56303 |
| CentraCare Clinic - River Campus | St. Cloud, Minnesota 56303 |
| Immanuel Medical Center | Omaha, Nebraska 68122 |
| Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
| MeritCare Medical Group | Fargo, North Dakota 58122 |
| Wood County Oncology Center | Bowling Green, Ohio 43402 |
| Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
| Fremont Memorial Hospital | Fremont, Ohio 43420 |
| Kenton Oncology, Incorporated | Kenton, Ohio 43326 |
| Lima Memorial Hospital | Lima, Ohio 45804 |
| St. Luke's Hospital | Maumee, Ohio 43537 |
| Northwest Ohio Oncology Center | Maumee, Ohio 43537 |
| Toledo Clinic - Oregon | Oregon, Ohio 43616 |
| St. Charles Mercy Hospital | Oregon, Ohio 43616 |
| North Coast Cancer Care, Incorporated | Sandusky, Ohio 44870 |
| Firelands Regional Medical Center | Sandusky, Ohio 44870 |
| Mercy Hospital of Tiffin | Tiffin, Ohio 44883 |
| Toledo Clinic, Incorporated - Main Clinic | Toledo, Ohio 43623 |
| Fulton County Health Center | Wauseon, Ohio 43567 |
| Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
| Miller-Dwan Medical Center | Duluth, Minnesota 55805 |
| Franciscan Skemp Healthcare | La Crosse, Wisconsin 54601-4796 |
| Mercy Cancer Center at Mercy Medical Center - North Iowa | Mason City, Iowa 50401 |
| Adult and Pediatric Urology, P.L.L.P. | St. Cloud, Minnesota 56303 |
| Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
| McFarland Clinic, PC | Ames, Iowa 50010 |
| Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
| Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
| Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
| Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
| Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
| Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
| Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
| Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
| Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
| Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
| Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
| Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville, Michigan 48144 |
| Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha, Nebraska 68124 |
| Flower Hospital Cancer Center | Sylvania, Ohio 43560 |
| Sansum Medical Clinic | Santa Barbara, California 93105 |
| Immanuel St. Joseph's Clinic | Mankato, Minnesota 56002 |
| Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara | Santa Barbara, California 93105 |
| Santa Barbara Hematology Oncology - Solvang | Solvang, California 93463 |
| Hattiesburg Clinic, PA at Forrest General | Hattiesburg, Mississippi 39401 |
| Clinic of Dr. Judy L. Schmidt | Missoula, Montana 59804 |
| Santa Barbara Hematology Oncology - Lompoc | Lompoc, California 93438 |
| Ottumwa Regional Health Center Cancer Center | Ottumwa, Iowa 52501 |
| Hematology & Oncology Clinic | Hattiesburg, Mississippi 39402 |
