Spots Global Cancer Trial Database for Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil
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Trial Identification
Brief Title: Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil
Official Title: A Phase 3 Randomized Placebo Controlled Clinical Trial of Donepezil in Chemotherapy Exposed Breast Cancer Survivors With Cognitive Impairment
Study ID: NCT02822573
Study Description
Brief Summary: This study is to compare the safety and effects of donepezil (Aricept) for patients reporting cognitive or memory issues after receiving chemotherapy for breast cancer. Patients will receive either donepezil or placebo for 24 weeks. The primary objective is to see if memory improves with the use of donepezil during the study.
Detailed Description: Randomized, double-blind, placebo-controlled study with 24 weeks of exposure to drug or placebo followed by a 12 week wash-out period. Patients who meet the eligibility criteria will be stratified by age (\<50, 50-59, 60-69, ≥70) and randomized to donepezil or placebo with equal probability. A total of 276 patients will be enrolled (138 per arm). We expect an accrual rate of 7-10 participants per month based on our prior feasibility study. We expect the study to be complete within 40 months. Participants will be asked to take one 5mg tablet of donepezil or one tablet of matching placebo orally once a day for 6 weeks followed by two 5mg tablets (10mg total) of donepezil or two placebo tablets orally once a day for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period. Time points for performing study assessments. Participants will be administered the cognitive battery of tests and questionnaires at baseline, week 12, week 24 and week 36. In addition, a single vial of blood will be drawn at baseline for apolipoprotein E (APOE) genotyping and subsequent bioassays (pending supplemental funding).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Kaiser Permanente-Anaheim, Anaheim, California, United States
Kaiser Permanente-Deer Valley Medical Center, Antioch, California, United States
Kaiser Permanente-Baldwin Park, Baldwin Park, California, United States
Kaiser Permanente-Bellflower, Bellflower, California, United States
Kaiser Permanente-Fontana, Fontana, California, United States
Kaiser Permanente-Fremont, Fremont, California, United States
Fresno Cancer Center, Fresno, California, United States
Kaiser Permanente-Fresno, Fresno, California, United States
Kaiser Permanente - Harbor City, Harbor City, California, United States
Kaiser Permanente-Irvine, Irvine, California, United States
Kaiser Permanente Los Angeles Medical Center, Los Angeles, California, United States
Kaiser Permanente West Los Angeles, Los Angeles, California, United States
Kaiser Permanente-Modesto, Modesto, California, United States
Kaiser Permanente-Oakland, Oakland, California, United States
Kaiser Permanente-Ontario, Ontario, California, United States
Kaiser Permanente - Panorama City, Panorama City, California, United States
Kaiser Permanente-Rancho Cordova Cancer Center, Rancho Cordova, California, United States
Kaiser Permanente-Richmond, Richmond, California, United States
Kaiser Permanente-Riverside, Riverside, California, United States
Kaiser Permanente-Roseville, Roseville, California, United States
The Permanente Medical Group-Roseville Radiation Oncology, Roseville, California, United States
Kaiser Permanente Downtown Commons, Sacramento, California, United States
Kaiser Permanente-South Sacramento, Sacramento, California, United States
South Sacramento Cancer Center, Sacramento, California, United States
Kaiser Permanente - Sacramento, Sacramento, California, United States
Kaiser Permanente-San Diego Zion, San Diego, California, United States
Kaiser Permanente-San Francisco, San Francisco, California, United States
Kaiser Permanente-Santa Teresa-San Jose, San Jose, California, United States
Kaiser Permanente San Leandro, San Leandro, California, United States
Kaiser Permanente-San Marcos, San Marcos, California, United States
Kaiser Permanente-San Rafael, San Rafael, California, United States
Kaiser San Rafael-Gallinas, San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara, Santa Clara, California, United States
Kaiser Permanente-Santa Rosa, Santa Rosa, California, United States
Kaiser Permanente-South San Francisco, South San Francisco, California, United States
Kaiser Permanente-Stockton, Stockton, California, United States
Kaiser Permanente Medical Center-Vacaville, Vacaville, California, United States
Kaiser Permanente-Vallejo, Vallejo, California, United States
Kaiser Permanente-Walnut Creek, Walnut Creek, California, United States
Kaiser Permanente-Woodland Hills, Woodland Hills, California, United States
Penrose-Saint Francis Healthcare, Colorado Springs, Colorado, United States
Rocky Mountain Cancer Centers-Penrose, Colorado Springs, Colorado, United States
Kaiser Permanente-Franklin, Denver, Colorado, United States
Porter Adventist Hospital, Denver, Colorado, United States
Kaiser Permanente-Rock Creek, Lafayette, Colorado, United States
Littleton Adventist Hospital, Littleton, Colorado, United States
Kaiser Permanente-Lone Tree, Lone Tree, Colorado, United States
Longmont United Hospital, Longmont, Colorado, United States
Parker Adventist Hospital, Parker, Colorado, United States
Helen F Graham Cancer Center, Newark, Delaware, United States
Medical Oncology Hematology Consultants PA, Newark, Delaware, United States
Christiana Care Health System-Christiana Hospital, Newark, Delaware, United States
Beebe Health Campus, Rehoboth Beach, Delaware, United States
TidalHealth Nanticoke / Allen Cancer Center, Seaford, Delaware, United States
Holy Cross Hospital, Fort Lauderdale, Florida, United States
Pali Momi Medical Center, 'Aiea, Hawaii, United States
Hawaii Cancer Care Inc - Waterfront Plaza, Honolulu, Hawaii, United States
Queen's Cancer Cenrer - POB I, Honolulu, Hawaii, United States
Queen's Medical Center, Honolulu, Hawaii, United States
Straub Clinic and Hospital, Honolulu, Hawaii, United States
University of Hawaii Cancer Center, Honolulu, Hawaii, United States
Hawaii Cancer Care Inc-Liliha, Honolulu, Hawaii, United States
Queen's Cancer Center - Kuakini, Honolulu, Hawaii, United States
Kaiser Permanente Moanalua Medical Center, Honolulu, Hawaii, United States
Kapiolani Medical Center for Women and Children, Honolulu, Hawaii, United States
Saint Luke's Cancer Institute - Boise, Boise, Idaho, United States
Saint Luke's Cancer Institute - Fruitland, Fruitland, Idaho, United States
Saint Luke's Cancer Institute - Meridian, Meridian, Idaho, United States
Saint Luke's Cancer Institute - Nampa, Nampa, Idaho, United States
Saint Luke's Cancer Institute - Twin Falls, Twin Falls, Idaho, United States
Illinois CancerCare-Bloomington, Bloomington, Illinois, United States
Illinois CancerCare-Canton, Canton, Illinois, United States
Centralia Oncology Clinic, Centralia, Illinois, United States
Carle on Vermilion, Danville, Illinois, United States
Cancer Care Specialists of Illinois - Decatur, Decatur, Illinois, United States
Decatur Memorial Hospital, Decatur, Illinois, United States
Carle Physician Group-Effingham, Effingham, Illinois, United States
Crossroads Cancer Center, Effingham, Illinois, United States
Illinois CancerCare-Galesburg, Galesburg, Illinois, United States
Illinois CancerCare-Kewanee Clinic, Kewanee, Illinois, United States
Carle Physician Group-Mattoon/Charleston, Mattoon, Illinois, United States
Illinois CancerCare-Ottawa Clinic, Ottawa, Illinois, United States
Illinois CancerCare-Pekin, Pekin, Illinois, United States
Illinois CancerCare-Peoria, Peoria, Illinois, United States
Illinois CancerCare-Peru, Peru, Illinois, United States
Carle Cancer Center, Urbana, Illinois, United States
The Carle Foundation Hospital, Urbana, Illinois, United States
Physicians' Clinic of Iowa PC, Cedar Rapids, Iowa, United States
Iowa Methodist Medical Center, Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines, Des Moines, Iowa, United States
Broadlawns Medical Center, Des Moines, Iowa, United States
Mercy Medical Center - Des Moines, Des Moines, Iowa, United States
Iowa Lutheran Hospital, Des Moines, Iowa, United States
Methodist West Hospital, West Des Moines, Iowa, United States
Cancer Center of Kansas - Chanute, Chanute, Kansas, United States
Cancer Center of Kansas - El Dorado, El Dorado, Kansas, United States
Cancer Center of Kansas - Fort Scott, Fort Scott, Kansas, United States
Cancer Center of Kansas-Independence, Independence, Kansas, United States
Cancer Center of Kansas-Kingman, Kingman, Kansas, United States
Cancer Center of Kansas-Manhattan, Manhattan, Kansas, United States
Cancer Center of Kansas - McPherson, McPherson, Kansas, United States
Cancer Center of Kansas - Newton, Newton, Kansas, United States
Cancer Center of Kansas - Parsons, Parsons, Kansas, United States
Cancer Center of Kansas - Salina, Salina, Kansas, United States
Cancer Center of Kansas - Wellington, Wellington, Kansas, United States
Associates In Womens Health, Wichita, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower, Wichita, Kansas, United States
Ascension Via Christi Hospitals Wichita, Wichita, Kansas, United States
Cancer Center of Kansas - Wichita, Wichita, Kansas, United States
Cancer Center of Kansas - Winfield, Winfield, Kansas, United States
Flaget Memorial Hospital, Bardstown, Kentucky, United States
Saint Joseph Radiation Oncology Resource Center, Lexington, Kentucky, United States
Saint Joseph Hospital East, Lexington, Kentucky, United States
Saint Joseph London, London, Kentucky, United States
Christus Saint Frances Cabrini Hospital, Alexandria, Louisiana, United States
LSU Health Baton Rouge-North Clinic, Baton Rouge, Louisiana, United States
Louisiana Hematology Oncology Associates LLC, Baton Rouge, Louisiana, United States
Mary Bird Perkins Cancer Center, Baton Rouge, Louisiana, United States
Our Lady of the Lake Physicians Group - Medical Oncology, Baton Rouge, Louisiana, United States
Louisiana State University Health Science Center, New Orleans, Louisiana, United States
University Medical Center New Orleans, New Orleans, Louisiana, United States
Ochsner Medical Center Jefferson, New Orleans, Louisiana, United States
CHRISTUS Highland Medical Center, Shreveport, Louisiana, United States
Saint Joseph Mercy Hospital, Ann Arbor, Michigan, United States
IHA Hematology Oncology Consultants-Brighton, Brighton, Michigan, United States
Saint Joseph Mercy Brighton, Brighton, Michigan, United States
IHA Hematology Oncology Consultants-Canton, Canton, Michigan, United States
Saint Joseph Mercy Canton, Canton, Michigan, United States
Caro Cancer Center, Caro, Michigan, United States
IHA Hematology Oncology Consultants-Chelsea, Chelsea, Michigan, United States
Saint Joseph Mercy Chelsea, Chelsea, Michigan, United States
Hematology Oncology Consultants-Clarkston, Clarkston, Michigan, United States
Newland Medical Associates-Clarkston, Clarkston, Michigan, United States
Beaumont Hospital - Dearborn, Dearborn, Michigan, United States
Green Bay Oncology - Escanaba, Escanaba, Michigan, United States
Beaumont Hospital - Farmington Hills, Farmington Hills, Michigan, United States
Genesee Cancer and Blood Disease Treatment Center, Flint, Michigan, United States
Genesee Hematology Oncology PC, Flint, Michigan, United States
Genesys Hurley Cancer Institute, Flint, Michigan, United States
Hurley Medical Center, Flint, Michigan, United States
Mercy Health Saint Mary's, Grand Rapids, Michigan, United States
Spectrum Health at Butterworth Campus, Grand Rapids, Michigan, United States
William Beaumont Hospital-Grosse Pointe, Grosse Pointe, Michigan, United States
Saint Mary Mercy Hospital, Livonia, Michigan, United States
Mercy Health Mercy Campus, Muskegon, Michigan, United States
Newland Medical Associates-Pontiac, Pontiac, Michigan, United States
Saint Joseph Mercy Oakland, Pontiac, Michigan, United States
Spectrum Health Reed City Hospital, Reed City, Michigan, United States
William Beaumont Hospital-Royal Oak, Royal Oak, Michigan, United States
Ascension Saint Mary's Hospital, Saginaw, Michigan, United States
Oncology Hematology Associates of Saginaw Valley PC, Saginaw, Michigan, United States
Ascension Saint Joseph Hospital, Tawas City, Michigan, United States
Munson Medical Center, Traverse City, Michigan, United States
William Beaumont Hospital - Troy, Troy, Michigan, United States
Saint Mary's Oncology/Hematology Associates of West Branch, West Branch, Michigan, United States
Metro Health Hospital, Wyoming, Michigan, United States
IHA Hematology Oncology Consultants-Ann Arbor, Ypsilanti, Michigan, United States
Fairview Ridges Hospital, Burnsville, Minnesota, United States
Mercy Hospital, Coon Rapids, Minnesota, United States
Fairview Southdale Hospital, Edina, Minnesota, United States
Unity Hospital, Fridley, Minnesota, United States
Fairview Clinics and Surgery Center Maple Grove, Maple Grove, Minnesota, United States
Minnesota Oncology Hematology PA-Maplewood, Maplewood, Minnesota, United States
Saint John's Hospital - Healtheast, Maplewood, Minnesota, United States
Abbott-Northwestern Hospital, Minneapolis, Minnesota, United States
Hennepin County Medical Center, Minneapolis, Minnesota, United States
Health Partners Inc, Minneapolis, Minnesota, United States
New Ulm Medical Center, New Ulm, Minnesota, United States
North Memorial Medical Health Center, Robbinsdale, Minnesota, United States
Park Nicollet Clinic - Saint Louis Park, Saint Louis Park, Minnesota, United States
Regions Hospital, Saint Paul, Minnesota, United States
United Hospital, Saint Paul, Minnesota, United States
Saint Francis Regional Medical Center, Shakopee, Minnesota, United States
Lakeview Hospital, Stillwater, Minnesota, United States
Ridgeview Medical Center, Waconia, Minnesota, United States
Rice Memorial Hospital, Willmar, Minnesota, United States
Minnesota Oncology Hematology PA-Woodbury, Woodbury, Minnesota, United States
Fairview Lakes Medical Center, Wyoming, Minnesota, United States
Baptist Memorial Hospital and Cancer Center-Golden Triangle, Columbus, Mississippi, United States
Baptist Memorial Hospital and Cancer Center-Union County, New Albany, Mississippi, United States
Baptist Memorial Hospital and Cancer Center-Oxford, Oxford, Mississippi, United States
Baptist Memorial Hospital and Cancer Center-Desoto, Southhaven, Mississippi, United States
Capital Region Southwest Campus, Jefferson City, Missouri, United States
Missouri Baptist Medical Center, Saint Louis, Missouri, United States
Mercy Hospital Springfield, Springfield, Missouri, United States
CHI Health Good Samaritan, Kearney, Nebraska, United States
Randolph Hospital, Asheboro, North Carolina, United States
Mission Hospital, Asheville, North Carolina, United States
AdventHealth Infusion Center Asheville, Asheville, North Carolina, United States
Hope Women's Cancer Centers-Asheville, Asheville, North Carolina, United States
Gaston Hematology and Oncology Associates-Belmont, Belmont, North Carolina, United States
UNC Lineberger Comprehensive Cancer Center, Chapel Hill, North Carolina, United States
Wake Forest University at Clemmons, Clemmons, North Carolina, United States
Southeastern Medical Oncology Center-Clinton, Clinton, North Carolina, United States
CaroMont Regional Medical Center, Gastonia, North Carolina, United States
Gaston Hematology and Oncology Associates, Gastonia, North Carolina, United States
Southeastern Medical Oncology Center-Goldsboro, Goldsboro, North Carolina, United States
Cone Health Cancer Center, Greensboro, North Carolina, United States
Margaret R Pardee Memorial Hospital, Hendersonville, North Carolina, United States
AdventHealth Hendersonville, Hendersonville, North Carolina, United States
Southeastern Medical Oncology Center-Jacksonville, Jacksonville, North Carolina, United States
Wake Forest University Health Sciences, Winston-Salem, North Carolina, United States
Sanford Bismarck Medical Center, Bismarck, North Dakota, United States
Sanford Broadway Medical Center, Fargo, North Dakota, United States
Sanford Roger Maris Cancer Center, Fargo, North Dakota, United States
Strecker Cancer Center-Belpre, Belpre, Ohio, United States
Good Samaritan Hospital - Cincinnati, Cincinnati, Ohio, United States
Bethesda North Hospital, Cincinnati, Ohio, United States
TriHealth Cancer Institute-Westside, Cincinnati, Ohio, United States
TriHealth Cancer Institute-Anderson, Cincinnati, Ohio, United States
Columbus Oncology and Hematology Associates Inc, Columbus, Ohio, United States
Riverside Methodist Hospital, Columbus, Ohio, United States
Armes Family Cancer Center, Findlay, Ohio, United States
Marietta Memorial Hospital, Marietta, Ohio, United States
Licking Memorial Hospital, Newark, Ohio, United States
Kaiser Permanente Northwest, Portland, Oregon, United States
Geisinger Medical Center, Danville, Pennsylvania, United States
Geisinger Medical Center-Cancer Center Hazleton, Hazleton, Pennsylvania, United States
Geisinger Medical Oncology-Lewisburg, Lewisburg, Pennsylvania, United States
Geisinger Cancer Services-Pottsville, Pottsville, Pennsylvania, United States
Community Medical Center, Scranton, Pennsylvania, United States
Geisinger Medical Oncology-Selinsgrove, Selinsgrove, Pennsylvania, United States
Geisinger Wyoming Valley/Henry Cancer Center, Wilkes-Barre, Pennsylvania, United States
AnMed Health Cancer Center, Anderson, South Carolina, United States
Prisma Health Cancer Institute - Spartanburg, Boiling Springs, South Carolina, United States
Prisma Health Cancer Institute - Easley, Easley, South Carolina, United States
Gibbs Cancer Center-Gaffney, Gaffney, South Carolina, United States
Tidelands Georgetown Memorial Hospital, Georgetown, South Carolina, United States
Prisma Health Cancer Institute - Butternut, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Faris, Greenville, South Carolina, United States
Prisma Health Cancer Institute - Eastside, Greenville, South Carolina, United States
Self Regional Healthcare, Greenwood, South Carolina, United States
Prisma Health Cancer Institute - Greer, Greer, South Carolina, United States
Gibbs Cancer Center-Pelham, Greer, South Carolina, United States
Prisma Health Cancer Institute - Seneca, Seneca, South Carolina, United States
Spartanburg Medical Center, Spartanburg, South Carolina, United States
MGC Hematology Oncology-Union, Union, South Carolina, United States
Sanford Cancer Center Oncology Clinic, Sioux Falls, South Dakota, United States
Sanford USD Medical Center - Sioux Falls, Sioux Falls, South Dakota, United States
Baptist Memorial Hospital and Cancer Center-Memphis, Memphis, Tennessee, United States
Baptist Memorial Hospital for Women, Memphis, Tennessee, United States
Family Cancer Center-Memphis, Memphis, Tennessee, United States
Meharry Medical College, Nashville, Tennessee, United States
Aurora Cancer Care-Southern Lakes VLCC, Burlington, Wisconsin, United States
Marshfield Clinic-Chippewa Center, Chippewa Falls, Wisconsin, United States
Marshfield Medical Center-EC Cancer Center, Eau Claire, Wisconsin, United States
Aurora Health Center-Fond du Lac, Fond Du Lac, Wisconsin, United States
Aurora Health Care Germantown Health Center, Germantown, Wisconsin, United States
Aurora Cancer Care-Grafton, Grafton, Wisconsin, United States
Saint Vincent Hospital Cancer Center Green Bay, Green Bay, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Saint Mary's, Green Bay, Wisconsin, United States
Aurora BayCare Medical Center, Green Bay, Wisconsin, United States
Aurora Cancer Care-Kenosha South, Kenosha, Wisconsin, United States
Gundersen Lutheran Medical Center, La Crosse, Wisconsin, United States
Marshfield Clinic - Ladysmith Center, Ladysmith, Wisconsin, United States
Holy Family Memorial Hospital, Manitowoc, Wisconsin, United States
Aurora Bay Area Medical Group-Marinette, Marinette, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Marinette, Marinette, Wisconsin, United States
Marshfield Medical Center-Marshfield, Marshfield, Wisconsin, United States
Aurora Cancer Care-Milwaukee, Milwaukee, Wisconsin, United States
Aurora Saint Luke's Medical Center, Milwaukee, Wisconsin, United States
Aurora Sinai Medical Center, Milwaukee, Wisconsin, United States
Marshfield Clinic-Minocqua Center, Minocqua, Wisconsin, United States
Cancer Center of Western Wisconsin, New Richmond, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Oconto Falls, Oconto Falls, Wisconsin, United States
Vince Lombardi Cancer Clinic - Oshkosh, Oshkosh, Wisconsin, United States
Aurora Cancer Care-Racine, Racine, Wisconsin, United States
Marshfield Medical Center-Rice Lake, Rice Lake, Wisconsin, United States
Vince Lombardi Cancer Clinic-Sheboygan, Sheboygan, Wisconsin, United States
Marshfield Clinic Stevens Point Center, Stevens Point, Wisconsin, United States
Saint Vincent Hospital Cancer Center at Sturgeon Bay, Sturgeon Bay, Wisconsin, United States
Aurora Medical Center in Summit, Summit, Wisconsin, United States
Vince Lombardi Cancer Clinic-Two Rivers, Two Rivers, Wisconsin, United States
Marshfield Clinic-Wausau Center, Wausau, Wisconsin, United States
Aurora Cancer Care-Milwaukee West, Wauwatosa, Wisconsin, United States
Aurora West Allis Medical Center, West Allis, Wisconsin, United States
Marshfield Medical Center - Weston, Weston, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center, Wisconsin Rapids, Wisconsin, United States
Contact Details
Name: Stephen R Rapp, PhD
Affiliation: Wake Forest University Health Sciences
Role: PRINCIPAL_INVESTIGATOR
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