EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer

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

Sponsoren

Hauptsponsor: Alliance for Clinical Trials in Oncology

Mitarbeiter: National Cancer Institute (NCI)

Quelle Alliance for Clinical Trials in Oncology
Kurze Zusammenfassung

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.

detaillierte Beschreibung

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.

Gesamtstatus Completed
Anfangsdatum December 2002
Fertigstellungstermin April 2015
Primäres Abschlussdatum October 2006
Phase Phase 3
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score. Baseline, 12 months after starting Chemotherapy.
Sekundäres Ergebnis
Messen Zeitfenster
Median Scores for Trail Making Tests A and B (Lower Scores Are Better). Baseline, 1, 6, 12, 18 and 24 months time points
Secondary Measure of Cognitive Function Using Trail Making Tests (TMT) A and B. Baseline, 1, 6, 12, 18 and 24 months post chemotherapy.
Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) Baseline, 1st evaluation of post chemotherapy.
Associations Between Self-reported Cognition and the HSCS. Baseline, 1, 6, 12, 18 and 24 months time points
Associations Between Self-report Measures of Cognition and the Trail Making Test (TMT) A and B. Baseline, 1, 6, 12, 18 and 24 months time points
Einschreibung 226
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: Ginkgo Biloba

Beschreibung: Patients will take 120 mg per day (60 mg BID)

Armgruppenetikett: Ginkgo Biloba

Interventionsart: Other

Interventionsname: Placebo

Beschreibung: Patients will take 1 tablet BID

Armgruppenetikett: Placebo

Teilnahmeberechtigung

Kriterien:

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)

Geschlecht: Female

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Debra Barton, RN, PhD, AOCN, FAAN Study Chair Mayo Clinic
Ort
Einrichtung:
Mayo Clinic Scottsdale | Scottsdale, Arizona, 85259-5499, 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, 80301-9019, 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, 80224-2522, 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, 30342-1611, United States
Saint Joseph's Hospital of Atlanta | Atlanta, Georgia, 30342-1701, 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, 30274-2600, 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, 50316-2301, 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, 708169990, 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, 48106-0995, United States
CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan, 48106, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan, 48123-2500, 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, 59107-7000, 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, 59807-7877, 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, 68131-2197, 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, 57117-5039, United States
Franciscan Skemp Healthcare | La Crosse, Wisconsin, 54601, United States
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming, 82801, United States
Standort Länder

United States

Überprüfungsdatum

July 2016

Verantwortliche Partei

Art: Sponsor

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 2
Armgruppe

Etikette: Ginkgo Biloba

Art: Experimental

Beschreibung: 120 mg per day (60 mg BID)

Etikette: Placebo

Art: Placebo Comparator

Beschreibung: 1 tablet BID

Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Supportive Care

Maskierung: Double (Participant, Investigator)

Quelle: ClinicalTrials.gov