EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer - Full Text View

Sponsor:	North Central Cancer Treatment Group
Collaborator:	National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00046891

Purpose

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.

Condition	Intervention
Breast Cancer Neurotoxicity	Dietary Supplement: EGb761

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Double-Blind, Placebo Control
Official Title:	The Use of Ginkgo Biloba For The Prevention Of Chemotherapy-Related Cognitive Dysfunction

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: EGB 761

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Estimated Enrollment:	220
Study Start Date:	December 2002
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Detailed 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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00046891

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Locations

United States, Arizona
Mayo Clinic Scottsdale
Scottsdale, Arizona, United States, 85259-5499
United States, California
Cancer Center of Santa Barbara
Snata Barbara, California, United States, 93105
Sansum Medical Clinic
Santa Barbara, California, United States, 93105
Santa Barbara Hematology Oncology - Lompoc
Lompoc, California, United States, 93438
Santa Barbara Hematology Oncology - Solvang
Solvang, California, United States, 93463
Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara
Santa Barbara, California, United States, 93105
United States, Colorado
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301-9019
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80224-2522
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States, 80502
North Suburban Medical Center
Thornton, Colorado, United States, 80229
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
Porter Adventist Hospital
Denver, Colorado, United States, 80210
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
Rose Medical Center
Denver, Colorado, United States, 80220
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
St. Joseph Hospital
Denver, Colorado, United States, 80218
St. Mary-Corwin Regional Medical Center
Pueblo, Colorado, United States, 81004
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
Grand Junction, Colorado, United States, 81502
Swedish Medical Center
Englewood, Colorado, United States, 80110
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
United States, Georgia
CCOP - Atlanta Regional
Atlanta, Georgia, United States, 30342
Charles B. Eberhart Cancer Center at DeKalb Medical Center
Decatur, Georgia, United States, 30033
Gwinnett Medical Center
Lawrenceville, Georgia, United States, 30045
Kennestone Cancer Center at Wellstar Kennestone Hospital
Marietta, Georgia, United States, 30060
MBCCOP - Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912
WellStar Cobb Hospital
Austell, Georgia, United States, 30106
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Saint Joseph's Hospital of Atlanta
Atlanta, Georgia, United States, 30342-1701
Southern Regional Medical Center
Riverdale, Georgia, United States, 30274-2600
Northside Hospital Cancer Center
Atlanta, Georgia, United States, 30342-1611
United States, Illinois
BroMenn Regional Medical Center
Normal, Illinois, United States, 61761
Graham Hospital
Canton, Illinois, United States, 61520
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61615
Community Cancer Center
Normal, Illinois, United States, 61761
Community Hospital of Ottawa
Ottawa, Illinois, United States, 61350
Eureka Community Hospital
Eureka, Illinois, United States, 61530
Galesburg Clinic
Galesburg, Illinois, United States, 61401
Galesburg Cottage Hospital
Galesburg, Illinois, United States, 61401

Moline, Illinois, United States, 61265
Cancer Treatment Center at Pekin Hospital
Pekin, Illinois, United States, 61554
Hopedale Medical Complex
Hopedale, Illinois, United States, 61747
Illinois Valley Community Hospital
Peru, Illinois, United States, 61354
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Kewanee Hospital
Kewanee, Illinois, United States, 61443
Mason District Hospital
Havana, Illinois, United States, 62644
McDonough District Hospital
Macomb, Illinois, United States, 61455
Proctor Hospital
Peoria, Illinois, United States, 61614
Methodist Medical Center of Illinois
Peoria, Illinois, United States, 61636
Oncology Hematology Associates of Central Illinois, PC - Ottawa
Ottawa, Illinois, United States, 61350
Oncology Hematology Associates of Central Illinois, PC - Peoria
Peoria, Illinois, United States, 61615
Memorial Hospital
Carthage, Illinois, United States, 62321
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
St. Margaret's Hospital
Spring Valley, Illinois, United States, 61362
Trinity Medical Center - East
Moline, Illinois, United States, 61265
United States, Indiana
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
United States, Iowa
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309
Cedar Rapids Oncology Associates
Cedar Rapids, Iowa, United States, 52403
Medical Oncology and Hematology Associates - West Des Moines
West Des Moines, Iowa, United States, 50266
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, United States, 50316-2301
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, United States, 50309
McFarland Clinic, PC
Ames, Iowa, United States, 50010

Bettendorf, Iowa, United States, 52722
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, United States, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, United States, 50314
Mercy Cancer Center at Mercy Medical Center - North Iowa
Mason City, Iowa, United States, 50401
Mercy Capitol Hospital
Des Moines, Iowa, United States, 50307
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
St. Luke's Hospital
Cedar Rapids, Iowa, United States, 52402
Ottumwa Regional Health Center Cancer Center
Ottumwa, Iowa, United States, 52501
Siouxland Hematology-Oncology Associates, LLP
Sioux City, Iowa, United States, 51101
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101
Mercy Regional Cancer Center at Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
United States, Kansas
Associates in Womens Health, PA - North Review
Wichita, Kansas, United States, 67203
Cancer Center of Kansas, PA - Kingman
Kingman, Kansas, United States, 67068
Cancer Center of Kansas, PA - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, PA - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas, PA - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, PA - Pratt
Pratt, Kansas, United States, 67124
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita, Kansas, United States, 67208
Cancer Center of Kansas, PA - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, PA - Parsons
Parsons, Kansas, United States, 67357
Cancer Center of Kansas, PA - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas, PA - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas, PA - Wellington
Wellington, Kansas, United States, 67152
Cancer Center of Kansas, PA - Winfield
Winfield, Kansas, United States, 67156
CCOP - Wichita
Wichita, Kansas, United States, 67214
Southwest Medical Center
Liberal, Kansas, United States, 67901
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
United States, Louisiana
Ochsner Cancer Institute at Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70121
Ochsner Clinic of Baton Rouge
Baton Rouge, Louisiana, United States, 708169990
Terrebonne General Medical Center
Houma, Louisiana, United States, 70360
United States, Michigan
CCOP - Michigan Cancer Research Consortium
Ann Arbor, Michigan, United States, 48106
Community Cancer Center of Monroe
Monroe, Michigan, United States, 48162
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Genesys Hurley Cancer Institute
Flint, Michigan, United States, 48503
Haematology-Oncology Associates of Ohio and Michigan, PC
Lambertville, Michigan, United States, 48144
Hickman Cancer Center at Bixby Medical Center
Adrian, Michigan, United States, 49221
Hurley Medical Center
Flint, Michigan, United States, 48503
Mercy Memorial Hospital System
Monroe, Michigan, United States, 48162
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn, Michigan, United States, 48123-2500
Seton Cancer Institute - Saginaw
Saginaw, Michigan, United States, 48601
Sparrow Regional Cancer Center
Lansing, Michigan, United States, 48909
St. John Macomb Hospital
Warren, Michigan, United States, 48093
Foote Hospital
Jackson, Michigan, United States, 49201
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods, Michigan, United States, 48236
United States, Minnesota
Adult and Pediatric Urology, P.L.L.P.
Sartell, Minnesota, United States, 56377
Brainerd Medical Center
Brainerd, Minnesota, United States, 56401
CCOP - Duluth
Duluth, Minnesota, United States, 55805
CentraCare Clinic - River Campus
St. Cloud, Minnesota, United States, 56303
Chippewa County - Montevideo Hospital
Montevideo, Minnesota, United States, 56265
Miller-Dwan Medical Center
Duluth, Minnesota, United States, 55805
Immanuel St. Joseph's Clinic
Mankato, Minnesota, United States, 56002
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
MeritCare Clinic - Bemidji
Bemidji, Minnesota, United States, 56601
Coborn Cancer Center
Saint Cloud, Minnesota, United States, 56303
St. Joseph's Medical Center
Brainerd, Minnesota, United States, 56401
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, United States, 55805

Fergus Falls, Minnesota, United States, 56537

Alexandria, Minnesota, United States, 56308
United States, Mississippi
Hattiesburg Clinic, PA at Forrest General
Hattiesburg, Mississippi, United States, 39401
Hematology & Oncology Clinic
Hattiesburg, Mississippi, United States, 39402
United States, Montana
Deaconess Billings Clinic - Downtown
Billings, Montana, United States, 59107-7000
CCOP - Montana Cancer Consortium
Billings, Montana, United States, 59101
Clinic of Dr. Judy L. Schmidt
Missoula, Montana, United States, 59804
Community Medical Center
Missoula, Montana, United States, 59801
Bozeman Deaconess Hospital
Bozeman, Montana, United States, 59715
Glacier Oncology, PLLC
Kalispell, Montana, United States, 59901
Great Falls Clinic
Great Falls, Montana, United States, 59405
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings, Montana, United States, 59101
Kalispell Medical Oncology
Kalispell, Montana, United States, 59901
Kalispell Regional Medical Center
Kalispell, Montana, United States, 59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula, Montana, United States, 59807
St. Vincent Healthcare
Billings, Montana, United States, 59101
Northern Rockies Radiation Oncology Center
Billings, Montana, United States, 59101
St. James Community Hospital
Butte, Montana, United States, 59701
St. Peter's Hospital
Helena, Montana, United States, 59601
Montana Cancer Specialists at Montana Cancer Center
Missoula, Montana, United States, 59807-7877
United States, Nebraska
Alegant Health Cancer Center at Bergan Mercy Medical Center
Omaha, Nebraska, United States, 68124
Cancer Resource Center - Lincoln
Lincoln, Nebraska, United States, 68510
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, United States, 68106
Creighton University Medical Center
Omaha, Nebraska, United States, 68131-2197
Immanuel Medical Center
Omaha, Nebraska, United States, 68122
United States, North Dakota
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
MeritCare Medical Group
Fargo, North Dakota, United States, 58122
United States, Ohio
Blanchard Valley Medical Associates
Findlay, Ohio, United States, 45840
CCOP - Toledo Community Hospital
Toledo, Ohio, United States, 43623
Firelands Regional Medical Center
Sandusky, Ohio, United States, 44870
Flower Hospital Cancer Center
Sylvania, Ohio, United States, 43560
Fremont Memorial Hospital
Fremont, Ohio, United States, 43420
Fulton County Health Center
Wauseon, Ohio, United States, 43567
Kenton Oncology, Incorporated
Kenton, Ohio, United States, 43326
Lima Memorial Hospital
Lima, Ohio, United States, 45804
Medical University of Ohio Cancer Center
Toledo, Ohio, United States, 43614
Mercy Hospital of Tiffin
Tiffin, Ohio, United States, 44883
St. Vincent Mercy Medical Center
Toledo, Ohio, United States, 43608
Northwest Ohio Oncology Center
Maumee, Ohio, United States, 43537
St. Charles Mercy Hospital
Oregon, Ohio, United States, 43616
St. Luke's Hospital
Maumee, Ohio, United States, 43537
North Coast Cancer Care, Incorporated
Sandusky, Ohio, United States, 44870
Toledo Clinic - Oregon
Oregon, Ohio, United States, 43616
Toledo Clinic, Incorporated - Main Clinic
Toledo, Ohio, United States, 43623
Toledo Hospital
Toledo, Ohio, United States, 43606
Wood County Oncology Center
Bowling Green, Ohio, United States, 43402
United States, Pennsylvania
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
Allentown, Pennsylvania, United States, 18105
United States, South Dakota
Avera Cancer Institute
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center, PC
Sioux Falls, South Dakota, United States, 57105
Rapid City Regional Hospital
Rapid City, South Dakota, United States, 57701
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57117-5039
United States, Wisconsin
Franciscan Skemp Healthcare
La Crosse, Wisconsin, United States, 54601
United States, Wyoming
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan, Wyoming, United States, 82801

Sponsors and Collaborators

North Central Cancer Treatment Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Debra Barton, RN, PhD, AOCN, FAAN

Mayo Clinic

Study ID Numbers:	CDR0000257008, NCCTG-N00C9, NCI-P02-0231
Study First Received:	October 3, 2002
Last Updated:	November 21, 2009
ClinicalTrials.gov Identifier:	NCT00046891 History of Changes
Health Authority:	United States: Federal Government