EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer
- Registration Number
- NCT00046891
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 226
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ginkgo Biloba Ginkgo Biloba 120 mg per day (60 mg BID) Placebo Placebo 1 tablet BID
- Primary Outcome Measures
Name Time Method The Level of Cognitive Dysfunction as Measured by the High Sensitivity Cognitive Screen (HSCS) Overall Score. Baseline, 12 months after starting Chemotherapy. The primary analysis involved compiling each subscale score for the HSCS into area under the curve (AUC) scores for the data points from baseline to the 12 month data point. HSCS instrument contains questions regarding Memory (0-39), Language (0-30), Visual-motor (0-10), Spatial (0-8), Attention and Concentration (0-25), Self-Regulation and Planning (0-6) on a varying scales. Total is calculated by summing afore mentioned subscales, values of Total ranged from 0 to 125. Lower scores are better.
- Secondary Outcome Measures
Name Time Method Median Scores for Trail Making Tests A and B (Lower Scores Are Better). Baseline, 1, 6, 12, 18 and 24 months time points The Trail Making Test is a measure of overall brain dysfunction. Time taken to complete TMT tests was recorded. For this analysis median values of the Trail Making tests are calculated at different 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. TMT A and B were analyzed by evaluating median changes from baseline to different time points. Lower scores are better. The Trail Making Test will provide additional validity and verification for the assessment of overall cognitive dysfunction. Abbreviations used for category titles in the table below: Baseline (BL), change (chg), month (mth).
Self-reported Symptoms or Side Effects Using Symptom Experience Diary (SED) Baseline, 1st evaluation of post chemotherapy. Self-reported symptoms or side effects mean change from baseline to 1st post chemo visit (negative numbers indicate worsening symptoms). A descriptive report of the toxicities experienced by participants will be measured with a Symptom Experience Diary. Participants will complete this questionnaire. This patient diary contains several questions related to potential side effects and side benefits of Ginko Biloba measured on a numeric analogue scale (based on 0-10 scale with 10 being worst toxicity).
Associations Between Self-reported Cognition and the HSCS. Baseline, 1, 6, 12, 18 and 24 months time points Pearson correlation coefficients conceptually related objective HSCS and subjective self-reported cognition. For this analysis data from both arms are combined. In the table below, numbers closer to 1 indicate positive correlation; numbers closer to -1 indicate negative correlation.
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 Pearson correlation coefficients conceptually related objective TMT A and B and subjective self-report measures of cognition. For this analysis data from both arms are combined. In the table below, numbers closer to 1 indicate positive correlation; numbers closer to -1 indicate negative correlation.
Trial Locations
- Locations (170)
Graham Hospital
🇺🇸Canton, Illinois, United States
St. John Macomb Hospital
🇺🇸Warren, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
MBCCOP - Medical College of Georgia Cancer Center
🇺🇸Augusta, Georgia, United States
Kalispell Medical Oncology
🇺🇸Kalispell, Montana, United States
Community Medical Center
🇺🇸Missoula, Montana, United States
McDonough District Hospital
🇺🇸Macomb, Illinois, United States
Siouxland Regional Cancer Center
🇺🇸Sioux City, Iowa, United States
Northwest Ohio Oncology Center
🇺🇸Maumee, Ohio, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Southwest Medical Center
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
Northern Rockies Radiation Oncology Center
🇺🇸Billings, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Deaconess Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Porter Adventist Hospital
🇺🇸Denver, Colorado, United States
Presbyterian - St. Luke's Medical Center
🇺🇸Denver, Colorado, United States
St. Joseph Hospital
🇺🇸Denver, Colorado, United States
Rose Medical Center
🇺🇸Denver, Colorado, United States
CCOP - Colorado Cancer Research Program, Incorporated
🇺🇸Denver, Colorado, United States
Immanuel Medical Center
🇺🇸Omaha, Nebraska, United States
Alegant Health Cancer Center at Bergan Mercy Medical Center
🇺🇸Omaha, Nebraska, United States
Creighton University Medical Center
🇺🇸Omaha, Nebraska, United States
Cancer Center of Santa Barbara
🇺🇸Snata Barbara, California, United States
St. Margaret's Hospital
🇺🇸Spring Valley, Illinois, United States
Saint Anthony Memorial Health Centers
🇺🇸Michigan City, Indiana, United States
Mercy Cancer Center at Mercy Medical Center - North Iowa
🇺🇸Mason City, Iowa, United States
Ottumwa Regional Health Center Cancer Center
🇺🇸Ottumwa, Iowa, United States
Medical Oncology and Hematology Associates - West Des Moines
🇺🇸West Des Moines, Iowa, United States
Mercy Medical Center - Sioux City
🇺🇸Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Hickman Cancer Center at Bixby Medical Center
🇺🇸Adrian, Michigan, United States
Foote Hospital
🇺🇸Jackson, Michigan, United States
St. Vincent Healthcare
🇺🇸Billings, Montana, United States
Great Falls Clinic
🇺🇸Great Falls, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Kenton Oncology, Incorporated
🇺🇸Kenton, Ohio, United States
Flower Hospital Cancer Center
🇺🇸Sylvania, Ohio, United States
St. Vincent Mercy Medical Center
🇺🇸Toledo, Ohio, United States
Haematology-Oncology Associates of Ohio and Michigan, PC
🇺🇸Lambertville, Michigan, United States
Community Cancer Center of Monroe
🇺🇸Monroe, Michigan, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
CCOP - Illinois Oncology Research Association
🇺🇸Peoria, Illinois, United States
Methodist Medical Center of Illinois
🇺🇸Peoria, Illinois, United States
Galesburg Clinic
🇺🇸Galesburg, Illinois, United States
CCOP - Carle Cancer Center
🇺🇸Urbana, Illinois, United States
Bozeman Deaconess Hospital
🇺🇸Bozeman, Montana, United States
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Sansum Medical Clinic
🇺🇸Santa Barbara, California, United States
Santa Barbara Hematology Oncology - Lompoc
🇺🇸Lompoc, California, United States
Santa Barbara Hematology Oncology Medical Group at Cancer Center of Santa Barbara
🇺🇸Santa Barbara, California, United States
Santa Barbara Hematology Oncology - Solvang
🇺🇸Solvang, California, United States
Boulder Community Hospital
🇺🇸Boulder, Colorado, United States
Penrose Cancer Center at Penrose Hospital
🇺🇸Colorado Springs, Colorado, United States
Swedish Medical Center
🇺🇸Englewood, Colorado, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
🇺🇸Grand Junction, Colorado, United States
Sky Ridge Medical Center
🇺🇸Lone Tree, Colorado, United States
Hope Cancer Care Center at Longmont United Hospital
🇺🇸Longmont, Colorado, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
North Suburban Medical Center
🇺🇸Thornton, Colorado, United States
St. Mary-Corwin Regional Medical Center
🇺🇸Pueblo, Colorado, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Northside Hospital Cancer Center
🇺🇸Atlanta, Georgia, United States
Charles B. Eberhart Cancer Center at DeKalb Medical Center
🇺🇸Decatur, Georgia, United States
CCOP - Atlanta Regional
🇺🇸Atlanta, Georgia, United States
Saint Joseph's Hospital of Atlanta
🇺🇸Atlanta, Georgia, United States
WellStar Cobb Hospital
🇺🇸Austell, Georgia, United States
Gwinnett Medical Center
🇺🇸Lawrenceville, Georgia, United States
Kennestone Cancer Center at Wellstar Kennestone Hospital
🇺🇸Marietta, Georgia, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
Southern Regional Medical Center
🇺🇸Riverdale, Georgia, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
Hopedale Medical Complex
🇺🇸Hopedale, Illinois, United States
Joliet Oncology-Hematology Associates, Limited - West
🇺🇸Joliet, Illinois, United States
Kewanee Hospital
🇺🇸Kewanee, Illinois, United States
Trinity Medical Center - East
🇺🇸Moline, Illinois, United States
BroMenn Regional Medical Center
🇺🇸Normal, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Ottawa
🇺🇸Ottawa, Illinois, United States
Community Hospital of Ottawa
🇺🇸Ottawa, Illinois, United States
Cancer Treatment Center at Pekin Hospital
🇺🇸Pekin, Illinois, United States
Community Cancer Center
🇺🇸Normal, Illinois, United States
Proctor Hospital
🇺🇸Peoria, Illinois, United States
Oncology Hematology Associates of Central Illinois, PC - Peoria
🇺🇸Peoria, Illinois, United States
Illinois Valley Community Hospital
🇺🇸Peru, Illinois, United States
Carle Cancer Center at Carle Foundation Hospital
🇺🇸Urbana, Illinois, United States
McFarland Clinic, PC
🇺🇸Ames, Iowa, United States
Cedar Rapids Oncology Associates
🇺🇸Cedar Rapids, Iowa, United States
St. Luke's Hospital
🇺🇸Maumee, Ohio, United States
Mercy Regional Cancer Center at Mercy Medical Center
🇺🇸Cedar Rapids, Iowa, United States
Siouxland Hematology-Oncology Associates, LLP
🇺🇸Sioux City, Iowa, United States
St. Luke's Regional Medical Center
🇺🇸Sioux City, Iowa, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Ochsner Clinic of Baton Rouge
🇺🇸Baton Rouge, Louisiana, United States
Terrebonne General Medical Center
🇺🇸Houma, Louisiana, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
🇺🇸Dearborn, Michigan, United States
Genesys Hurley Cancer Institute
🇺🇸Flint, Michigan, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
🇺🇸Grosse Pointe Woods, Michigan, United States
Sparrow Regional Cancer Center
🇺🇸Lansing, Michigan, United States
Mercy Memorial Hospital System
🇺🇸Monroe, Michigan, United States
Seton Cancer Institute - Saginaw
🇺🇸Saginaw, Michigan, United States
MeritCare Clinic - Bemidji
🇺🇸Bemidji, Minnesota, United States
Brainerd Medical Center
🇺🇸Brainerd, Minnesota, United States
St. Joseph's Medical Center
🇺🇸Brainerd, Minnesota, United States
St. Mary's - Duluth Clinic Cancer Center
🇺🇸Duluth, Minnesota, United States
CCOP - Duluth
🇺🇸Duluth, Minnesota, United States
Immanuel St. Joseph's Clinic
🇺🇸Mankato, Minnesota, United States
Miller-Dwan Medical Center
🇺🇸Duluth, Minnesota, United States
Chippewa County - Montevideo Hospital
🇺🇸Montevideo, Minnesota, United States
Mayo Clinic Cancer Center
🇺🇸Rochester, Minnesota, United States
Coborn Cancer Center
🇺🇸Saint Cloud, Minnesota, United States
Adult and Pediatric Urology, P.L.L.P.
🇺🇸Sartell, Minnesota, United States
CentraCare Clinic - River Campus
🇺🇸St. Cloud, Minnesota, United States
Hattiesburg Clinic, PA at Forrest General
🇺🇸Hattiesburg, Mississippi, United States
Hematology & Oncology Clinic
🇺🇸Hattiesburg, Mississippi, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
St. James Community Hospital
🇺🇸Butte, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
Clinic of Dr. Judy L. Schmidt
🇺🇸Missoula, Montana, United States
Cancer Resource Center - Lincoln
🇺🇸Lincoln, Nebraska, United States
CCOP - Missouri Valley Cancer Consortium
🇺🇸Omaha, Nebraska, United States
CCOP - MeritCare Hospital
🇺🇸Fargo, North Dakota, United States
Wood County Oncology Center
🇺🇸Bowling Green, Ohio, United States
St. Charles Mercy Hospital
🇺🇸Oregon, Ohio, United States
Lima Memorial Hospital
🇺🇸Lima, Ohio, United States
Toledo Clinic - Oregon
🇺🇸Oregon, Ohio, United States
Firelands Regional Medical Center
🇺🇸Sandusky, Ohio, United States
North Coast Cancer Care, Incorporated
🇺🇸Sandusky, Ohio, United States
Mercy Hospital of Tiffin
🇺🇸Tiffin, Ohio, United States
Toledo Hospital
🇺🇸Toledo, Ohio, United States
Medical University of Ohio Cancer Center
🇺🇸Toledo, Ohio, United States
CCOP - Toledo Community Hospital
🇺🇸Toledo, Ohio, United States
Toledo Clinic, Incorporated - Main Clinic
🇺🇸Toledo, Ohio, United States
Fulton County Health Center
🇺🇸Wauseon, Ohio, United States
Rapid City Regional Hospital
🇺🇸Rapid City, South Dakota, United States
Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest
🇺🇸Allentown, Pennsylvania, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Medical X-Ray Center, PC
🇺🇸Sioux Falls, South Dakota, United States
Sioux Valley Hospital and University of South Dakota Medical Center
🇺🇸Sioux Falls, South Dakota, United States
Franciscan Skemp Healthcare
🇺🇸La Crosse, Wisconsin, United States
MeritCare Medical Group
🇺🇸Fargo, North Dakota, United States
Aurora Presbyterian Hospital
🇺🇸Aurora, Colorado, United States
Mercy Capitol Hospital
🇺🇸Des Moines, Iowa, United States
CCOP - Iowa Oncology Research Association
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates at Mercy Cancer Center
🇺🇸Des Moines, Iowa, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
Ochsner Cancer Institute at Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
St. Joseph Mercy Cancer Center at St. Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
CCOP - Michigan Cancer Research Consortium
🇺🇸Ann Arbor, Michigan, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Fremont Memorial Hospital
🇺🇸Fremont, Ohio, United States