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The Use of Ginkgo Biloba For The Prevention Of Chemotherapy-Related Cognitive Dysfunction


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer, Neurotoxicity

Thank you

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 ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Aurora Presbyterian HospitalAurora, Colorado  80012
Boulder Community HospitalBoulder, Colorado  80301-9019
Penrose Cancer Center at Penrose HospitalColorado Springs, Colorado  80933
Porter Adventist HospitalDenver, Colorado  80210
Presbyterian - St. Luke's Medical CenterDenver, Colorado  80218
St. Joseph HospitalDenver, Colorado  80218
Rose Medical CenterDenver, Colorado  80220
Swedish Medical CenterEnglewood, Colorado  80110
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical CenterGrand Junction, Colorado  81502
Sky Ridge Medical CenterLone Tree, Colorado  80124
Hope Cancer Care Center at Longmont United HospitalLongmont, Colorado  80502
North Suburban Medical CenterThornton, Colorado  80229
Rush-Copley Cancer Care CenterAurora, Illinois  60507
Joliet Oncology-Hematology Associates, Limited - WestJoliet, Illinois  60435
Carle Cancer Center at Carle Foundation HospitalUrbana, Illinois  61801
Saint Anthony Memorial Health CentersMichigan City, Indiana  46360
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Foote HospitalJackson, Michigan  49201
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
Seton Cancer Institute - SaginawSaginaw, Michigan  48601
St. John Macomb HospitalWarren, Michigan  48093
CCOP - DuluthDuluth, Minnesota  55805
CCOP - MeritCare HospitalFargo, North Dakota  58122
Medical X-Ray Center, PCSioux Falls, South Dakota  57105
Avera Cancer InstituteSioux Falls, South Dakota  57105
Rapid City Regional HospitalRapid City, South Dakota  57709
Methodist Medical Center of IllinoisPeoria, Illinois  61636
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Hinsdale, Illinois  60521
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
St. Vincent Mercy Medical CenterToledo, Ohio  43608
CCOP - Colorado Cancer Research Program, IncorporatedDenver, Colorado  80224
Great Falls ClinicGreat Falls, Montana  59405
Northside Hospital Cancer CenterAtlanta, Georgia  30342-1611
Sioux Valley Hospital and University of South Dakota Medical CenterSioux Falls, South Dakota  57117-5134
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Ochsner Cancer Institute at Ochsner Clinic FoundationNew Orleans, Louisiana  70121
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
St. Mary's - Duluth Clinic Cancer CenterDuluth, Minnesota  55805
Siouxland Regional Cancer CenterSioux City, Iowa  51101-1733
Southwest Medical CenterLiberal, Kansas  67901
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Hematology-Oncology Centers of the Northern Rockies - BillingsBillings, Montana  59101
St. Vincent HealthcareBillings, Montana  59101
Deaconess Billings Clinic - DowntownBillings, Montana  59101
Bozeman Deaconess HospitalBozeman, Montana  59715
St. James Community HospitalButte, Montana  59701
St. Peter's HospitalHelena, Montana  59601
Kalispell Medical OncologyKalispell, Montana  59901
Kalispell Regional Medical CenterKalispell, Montana  59901
Glacier Oncology, PLLCKalispell, Montana  59901
Montana Cancer Center at St. Patrick Hospital and Health Sciences CenterMissoula, Montana  59802
Montana Cancer Specialists at Montana Cancer CenterMissoula, Montana  59802
Community Medical CenterMissoula, Montana  59801
MBCCOP - Medical College of Georgia Cancer CenterAugusta, Georgia  30912-3730
Cancer Center of Santa BarbaraSanta Barbara, California  93105
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
St. Mary-Corwin Regional Medical CenterPueblo, Colorado  81004
Saint Joseph's Hospital of AtlantaAtlanta, Georgia  30342-1701
Piedmont HospitalAtlanta, Georgia  30309
WellStar Cobb HospitalAustell, Georgia  30106
Charles B. Eberhart Cancer Center at DeKalb Medical CenterDecatur, Georgia  30033
Gwinnett Medical CenterLawrenceville, Georgia  30045
Kennestone Cancer Center at Wellstar Kennestone HospitalMarietta, Georgia  30060
Southern Regional Medical CenterRiverdale, Georgia  30274-2600
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
Trinity Medical Center - EastMoline, Illinois  61265
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Oncology Hematology Associates of Central Illinois, PC - OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
Oncology Hematology Associates of Central Illinois, PC - PeoriaPeoria, Illinois  61615
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
St. Margaret's HospitalSpring Valley, Illinois  61362
Bettendorf, Iowa  52722
St. Luke's HospitalCedar Rapids, Iowa  52402
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Capitol HospitalDes Moines, Iowa  50307
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Ochsner Clinic of Baton RougeBaton Rouge, Louisiana  708169990
Terrebonne General Medical CenterHouma, Louisiana  70360
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
St. Joseph Mercy Cancer Center at St. Joseph Mercy HospitalAnn Arbor, Michigan  48106-0995
Community Cancer Center of MonroeMonroe, Michigan  48162
Mercy Memorial Hospital SystemMonroe, Michigan  48162
Alexandria, Minnesota  56308
MeritCare Clinic - BemidjiBemidji, Minnesota  56601
Brainerd Medical CenterBrainerd, Minnesota  56401
St. Joseph's Medical CenterBrainerd, Minnesota  56401
Chippewa County - Montevideo HospitalMontevideo, Minnesota  56265
Coborn Cancer CenterSaint Cloud, Minnesota  56303
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
MeritCare Medical GroupFargo, North Dakota  58122
Wood County Oncology CenterBowling Green, Ohio  43402
Blanchard Valley Medical AssociatesFindlay, Ohio  45840
Fremont Memorial HospitalFremont, Ohio  43420
Kenton Oncology, IncorporatedKenton, Ohio  43326
Lima Memorial HospitalLima, Ohio  45804
St. Luke's HospitalMaumee, Ohio  43537
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Toledo Clinic - OregonOregon, Ohio  43616
St. Charles Mercy HospitalOregon, Ohio  43616
North Coast Cancer Care, IncorporatedSandusky, Ohio  44870
Firelands Regional Medical CenterSandusky, Ohio  44870
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
Fulton County Health CenterWauseon, Ohio  43567
Welch Cancer Center at Sheridan Memorial HospitalSheridan, Wyoming  82801
Miller-Dwan Medical CenterDuluth, Minnesota  55805
Franciscan Skemp HealthcareLa Crosse, Wisconsin  54601-4796
Mercy Cancer Center at Mercy Medical Center - North IowaMason City, Iowa  50401
Adult and Pediatric Urology, P.L.L.P.St. Cloud, Minnesota  56303
Cancer Resource Center - LincolnLincoln, Nebraska  68510
McFarland Clinic, PCAmes, Iowa  50010
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Haematology-Oncology Associates of Ohio and Michigan, PCLambertville, Michigan  48144
Alegant Health Cancer Center at Bergan Mercy Medical CenterOmaha, Nebraska  68124
Flower Hospital Cancer CenterSylvania, Ohio  43560
Sansum Medical ClinicSanta Barbara, California  93105
Immanuel St. Joseph's ClinicMankato, Minnesota  56002
Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa BarbaraSanta Barbara, California  93105
Santa Barbara Hematology Oncology - SolvangSolvang, California  93463
Hattiesburg Clinic, PA at Forrest GeneralHattiesburg, Mississippi  39401
Clinic of Dr. Judy L. SchmidtMissoula, Montana  59804
Santa Barbara Hematology Oncology - LompocLompoc, California  93438
Ottumwa Regional Health Center Cancer CenterOttumwa, Iowa  52501
Hematology & Oncology ClinicHattiesburg, Mississippi  39402