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Donepezil Hydrochloride in Improving Memory Performance in Breast Cancer Survivors after Chemotherapy

Trial Status: Active

This randomized phase III trial studies how well donepezil hydrochloride works in improving memory performance in breast cancer survivors after chemotherapy. Donepezil hydrochloride may help improve memory function affected by chemotherapy treatment in breast cancer survivors.

Inclusion Criteria

  • History of invasive breast cancer
  • Must have completed at least 4 cycles of adjuvant/neo-adjuvant cytotoxic chemotherapy between 1 and 5 years prior to registration (ongoing herceptin or other chronic human epidermal growth factor receptor [HER] 2 directed therapies are allowed)
  • Patients receiving ongoing hormonal therapy for breast cancer must be on the same hormonal agent for at least 3 months prior to study registration and plan to continue for the duration of the study (9 months)
  • Use of psychotropic medications (anti-depressants, anxiolytics, sleeping aids, narcotics) is permitted if the patient whose eligibility is being assessed has been on the medication for at least 12 weeks; the dose of this medication must be stable for at least 4 weeks prior to enrollment * Patients who were previously on one of these psychotropic medications and have subsequently discontinued the drug must have been off the medication for at least 4 weeks prior to enrollment * Patients who have been on a psychotropic medication for at least 12 weeks but have recently switched to a medicine in the same class (for example, switching from one selective serotonin reuptake inhibitor [SSRI] antidepressant to a different SSRI antidepressant) need to be on a stable dose of the new medication for at least 4 weeks prior to enrollment to be eligible
  • Self-reported cognitive problem plus a measured memory deficit (score =< 7 on single trial of eligibility pre-screen Hopkins Verbal Learning Test-Revised [HVLT-R] form C)
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
  • Able to understand and the willingness to sign a written informed consent document
  • Must be able to speak English
  • Patients currently taking a moderate risk corrected QT interval (QTc) prolongation medication are allowed if one of the following criteria are met: * The moderate risk QTc prolongation medication is stopped; the patient should be off the moderate risk QTc prolongation medication for at least 5 half-lives before starting study drug * Patients that continue using a moderate risk QTc prolongation medication must have a normal QTc interval (=< 460 milliseconds) on a screening electrocardiography (ECG) following informed consent and prior to study enrollment; these patients will also be monitored at designated study follow-up visits (monitored 3-7 days after initiating study drug, at week 3, and 3-7 days after the study drug dose increase with ECG’s to assess the QTc interval; the QTc level must be =< 500 milliseconds at these time points in order to continue on the study drug) * Moderate risk QTc prolongation medications that are only taken occasionally may be stopped at the discretion of the treating site physician; patients must be off medication for at least 5 half-lives prior to starting study drug to be eligible
  • Patients currently taking a moderate risk bradycardia-causing agent are allowed if one of the following criteria are met: * The moderate risk bradycardia-causing agent is stopped; the patient should be off the moderate risk bradycardia-causing agent for at least 5 half-lives before starting study drug * Patients that continue using a moderate risk bradycardia-causing agent must have a resting heart rate >= 55 beats per minute at screening following informed consent; these patients’ resting heart rate will be monitored 3-7 days after initiating study drug, at week 3, and 3-7 days after the study drug dose increase * Moderate risk bradycardia-causing agents that are only taken occasionally may be stopped at the discretion of the treating site physician; patients must be off medication for at least 5 half-lives prior to starting study drug to be eligible

Exclusion Criteria

  • Evidence or suspected recurrent or metastatic disease
  • Prior brain irradiation
  • Planned therapy (surgery, radiation, chemotherapy, or immunotherapy) while on the study for brain and/or extracranial primary/metastatic disease
  • Hypersensitivity to donepezil or piperidine derivatives
  • Current use of ceritinib
  • Current use of succinylcholine/acetylcholinesterase inhibitors as listed; for patients who have used these medications, they must not have used them within 4 weeks prior to enrollment
  • Current use of high-risk QTc prolonging medication(s)
  • Current use of quinidine or systemic ketoconazole (topical ketoconazole is acceptable to use while on study)
  • History of dementia, Alzheimer’s disease, multi-infarct dementia or clinically significant cerebrovascular accident (history of transient ischemic attack [TIA] is allowed)
  • Current use of donepezil, galantamine, rivastigmine, tacrine, memantine, methylphenidate, dextroamphetamine, or any other specific cognition enhancing drug(s); for patients who have used these medications, they must not have used them within 4 weeks prior to pre-screening; patients who plan to start taking a cognition enhancing drug while on this study are also excluded
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to donepezil. Hypersensitivity to donepezil
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, recent myocardial infarction, or cardiac arrhythmia
  • Major medical conditions that affect cognition, traumatic brain injury, multiple sclerosis, acute severe fatigue, chronic fatigue syndrome or fibromyalgia
  • Psychiatric illness/social situations that would limit compliance with study requirements including but not limited to a history of schizophrenia, psychosis or substance abuse
  • Untreated current severe depression; currently treated depression is permitted if treatment is stable
  • Patients with a resting heart rate less than 55 beats per minute, seizure disorder or peptic ulcer disease (PUD)
  • Screening QTc of > 460 milliseconds will make the patient ineligible
  • History of congenital long QT syndrome or torsades de pointes
  • Pregnant women are excluded from this study; following informed consent, women of childbearing potential will be screened with a serum or urine pregnancy test within 10 days of enrollment; the effects of donepezil on the developing human fetus at the recommended therapeutic dose are unknown; for this reason and because donepezil is known to be teratogenic, women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
  • It is unknown whether donepezil is excreted in breast milk, for this reason women who are currently breast-feeding are not eligible for this study
  • On another intervention study involving medication at the time of enrollment or during participation in this study; (exception: Patients will remain eligible for this study if they are also enrolled on the Alliance for Clinical Trials in Oncology study [NCT02927249]: Aspirin in Preventing Recurrence of Cancer in Patients with HER2 Negative Stage II-III Breast Cancer After Chemotherapy, Surgery, and/or Radiation Therapy; studies that involve only blood draws or questionnaires are also permitted)
  • Use of investigational drugs likely to affect cognition within 30 days prior to pre-screening visit

California

Anaheim
Kaiser Permanente-Anaheim
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
Antioch
Kaiser Permanente-Deer Valley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Baldwin Park
Kaiser Permanente-Baldwin Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
Bellflower
Kaiser Permanente-Bellflower
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
Fontana
Kaiser Permanente-Fontana
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
Fremont
Kaiser Permanente-Fremont
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Fresno
Fresno Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Kaiser Permanente-Fresno
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Harbor City
Kaiser Permanente - Harbor City
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
Irvine
Kaiser Permanente-Irvine
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
Los Angeles
Kaiser Permanente Los Angeles Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
Kaiser Permanente-Cadillac
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
Modesto
Kaiser Permanente-Modesto
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Oakland
Kaiser Permanente-Oakland
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Panorama City
Kaiser Permanente - Panorama City
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
Rancho Cordova
Kaiser Permanente-Rancho Cordova Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Richmond
Kaiser Permanente-Richmond
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Riverside
Kaiser Permanente-Riverside
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
Roseville
Kaiser Permanente-Roseville
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
The Permanente Medical Group-Roseville Radiation Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Sacramento
Kaiser Permanente - Sacramento
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Kaiser Permanente Downtown Commons
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: kpoct@kp.org
Kaiser Permanente-South Sacramento
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
South Sacramento Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Diego
Kaiser Permanente-San Diego Zion
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
San Francisco
Kaiser Permanente-San Francisco
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Jose
Kaiser Permanente-Santa Teresa-San Jose
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Leandro
Kaiser Permanente San Leandro
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
San Marcos
Kaiser Permanente-San Marcos
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996
San Rafael
Kaiser Permanente-San Rafael
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Kaiser San Rafael-Gallinas
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Santa Clara
Kaiser Permanente Medical Center - Santa Clara
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Santa Rosa
Kaiser Permanente-Santa Rosa
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
South San Francisco
Kaiser Permanente-South San Francisco
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Stockton
Kaiser Permanente-Stockton
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Vacaville
Kaiser Permanente Medical Center-Vacaville
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Vallejo
Kaiser Permanente-Vallejo
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Walnut Creek
Kaiser Permanente-Walnut Creek
Status: ACTIVE
Contact: Site Public Contact
Phone: 877-642-4691
Email: Kpoct@kp.org
Woodland Hills
Kaiser Permanente-Woodland Hills
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-398-3996

Colorado

Colorado Springs
Penrose-Saint Francis Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Rocky Mountain Cancer Centers-Penrose
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Denver
Kaiser Permanente-Franklin
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-764-5056
Porter Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Lafayette
Kaiser Permanente-Rock Creek
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-764-5056
Littleton
Littleton Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Lone Tree
Kaiser Permanente-Lone Tree
Status: ACTIVE
Contact: Site Public Contact
Phone: 303-764-5056
Longmont
Longmont United Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Parker
Parker Adventist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

Delaware

Newark
Christiana Care Health System-Christiana Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Helen F Graham Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Medical Oncology Hematology Consultants PA
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-623-4450
Rehoboth Beach
Beebe Health Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-645-3100
Seaford
Nanticoke Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 302-645-3100

Hawaii

Aiea
Pali Momi Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-486-6000
Honolulu
Hawaii Cancer Care Inc-Liliha
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-536-4888
Hawaii Cancer Care Inc-POB II
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-524-6115
Hawaii Oncology Inc-Kuakini
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-531-8521
Hawaii Oncology Inc-POB I
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-532-0315
Kaiser Permanente Moanalua Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-432-5195
Kapiolani Medical Center for Women and Children
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-983-6090
Queen's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-545-8548
Straub Clinic and Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-522-4333
University of Hawaii Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 808-586-2979

Idaho

Boise
Saint Luke's Mountain States Tumor Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-2774
Fruitland
Saint Luke's Mountain States Tumor Institute - Fruitland
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-8059
Meridian
Saint Luke's Mountain States Tumor Institute - Meridian
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-8059
Nampa
Saint Luke's Mountain States Tumor Institute - Nampa
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-8059
Twin Falls
Saint Luke's Mountain States Tumor Institute-Twin Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 208-381-8059

Illinois

Bloomington
Illinois CancerCare-Bloomington
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Canton
Illinois CancerCare-Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Centralia
Centralia Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Danville
Carle on Vermilion
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Decatur
Cancer Care Specialists of Illinois - Decatur
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Decatur Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Effingham
Carle Physician Group-Effingham
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Crossroads Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 217-876-4740
Galesburg
Illinois CancerCare-Galesburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Kewanee
Illinois CancerCare-Kewanee Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Mattoon
Carle Physician Group-Mattoon / Charleston
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
Ottawa
Illinois CancerCare-Ottawa Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Pekin
Illinois CancerCare-Pekin
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Peoria
Illinois CancerCare-Peoria
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Peru
Illinois CancerCare-Peru
Status: ACTIVE
Contact: Site Public Contact
Phone: 309-243-3605
Urbana
Carle Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532
The Carle Foundation Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-446-5532

Iowa

Cedar Rapids
Physicians' Clinic of Iowa PC
Status: ACTIVE
Contact: Site Public Contact
Phone: 319-297-2900
Des Moines
Broadlawns Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-282-2200
Iowa Lutheran Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-241-8704
Iowa Methodist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-241-6727
Medical Oncology and Hematology Associates-Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-282-2921
Mercy Medical Center - Des Moines
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
West Des Moines
Methodist West Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 515-343-1000

Kansas

Chanute
Cancer Center of Kansas - Chanute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
El Dorado
Cancer Center of Kansas - El Dorado
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Fort Scott
Cancer Center of Kansas - Fort Scott
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Independence
Cancer Center of Kansas-Independence
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Kingman
Cancer Center of Kansas-Kingman
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Manhattan
Cancer Center of Kansas-Manhattan
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5784
McPherson
Cancer Center of Kansas - McPherson
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Newton
Cancer Center of Kansas - Newton
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Parsons
Cancer Center of Kansas - Parsons
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Salina
Cancer Center of Kansas - Salina
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Wellington
Cancer Center of Kansas - Wellington
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Wichita
Ascension Via Christi Hospitals Wichita
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 800-362-0070
Associates In Womens Health
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Cancer Center of Kansas - Wichita
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Cancer Center of Kansas-Wichita Medical Arts Tower
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374
Winfield
Cancer Center of Kansas - Winfield
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 316-268-5374

Kentucky

Bardstown
Flaget Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Lexington
Saint Joseph Hospital East
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Saint Joseph Radiation Oncology Resource Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
London
Saint Joseph London
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

Louisiana

Alexandria
Christus Saint Frances Cabrini Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 318-448-6976
Baton Rouge
LSU Health Baton Rouge-North Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 225-215-1353
Louisiana Hematology Oncology Associates LLC
Status: ACTIVE
Contact: Site Public Contact
Phone: 225-215-1353
Mary Bird Perkins Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 225-215-1353
Our Lady of the Lake Physicians Group - Medical Oncology
Status: ACTIVE
Contact: Site Public Contact
Phone: 225-215-1353
New Orleans
Louisiana State University Health Science Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-210-3539
Ochsner Medical Center Jefferson
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-703-8712
University Medical Center New Orleans
Status: ACTIVE
Contact: Site Public Contact
Phone: 504-210-3539
Shreveport
CHRISTUS Highland Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 318-681-4763

Michigan

Ann Arbor
Saint Joseph Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Brighton
IHA Hematology Oncology Consultants-Brighton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph Mercy Brighton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Canton
IHA Hematology Oncology Consultants-Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph Mercy Canton
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Caro
Caro Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Chelsea
IHA Hematology Oncology Consultants-Chelsea
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph Mercy Chelsea
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Clarkston
Hematology Oncology Consultants-Clarkston
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Newland Medical Associates-Clarkston
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Dearborn
Beaumont Hospital – Dearborn
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 248-551-7695
Escanaba
Green Bay Oncology - Escanaba
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889
Farmington Hills
Beaumont Hospital - Farmington Hills
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 248-551-7695
Flint
Genesee Cancer and Blood Disease Treatment Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Genesee Hematology Oncology PC
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Genesys Hurley Cancer Institute
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Hurley Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Grand Rapids
Mercy Health Saint Mary's
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Spectrum Health at Butterworth Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Grosse Pointe
William Beaumont Hospital-Grosse Point
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 248-551-7695
Livonia
Saint Mary Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Muskegon
Mercy Health Mercy Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Pontiac
Newland Medical Associates-Pontiac
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Saint Joseph Mercy Oakland
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Reed City
Spectrum Health Reed City Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Royal Oak
William Beaumont Hospital-Royal Oak
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 248-551-7695
Saginaw
Ascension Saint Mary's Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Oncology Hematology Associates of Saginaw Valley PC
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Tawas City
Ascension Saint Joseph Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Traverse City
Munson Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Troy
William Beaumont Hospital - Troy
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 248-551-7695
West Branch
Saint Mary's Oncology / Hematology Associates of West Branch
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671
Wyoming
Metro Health Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 616-391-1230
Ypsilanti
IHA Hematology Oncology Consultants-Ann Arbor
Status: ACTIVE
Contact: Site Public Contact
Phone: 734-712-3671

Minnesota

Burnsville
Fairview Ridges Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Coon Rapids
Mercy Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Edina
Fairview-Southdale Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Fridley
Unity Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Maple Grove
Fairview Maple Grove Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Maplewood
Minnesota Oncology Hematology PA-Maplewood
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Saint John's Hospital - Healtheast
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Minneapolis
Abbott-Northwestern Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Health Partners Inc
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Hennepin County Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
New Ulm
New Ulm Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Robbinsdale
North Memorial Medical Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Saint Louis Park
Park Nicollet Clinic - Saint Louis Park
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Saint Paul
Regions Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
United Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Shakopee
Saint Francis Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Stillwater
Lakeview Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Waconia
Ridgeview Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Willmar
Rice Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Woodbury
Minnesota Oncology Hematology PA-Woodbury
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Wyoming
Fairview Lakes Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517

Mississippi

Columbus
Baptist Memorial Hospital and Cancer Center-Golden Triangle
Status: ACTIVE
Contact: Site Public Contact
Phone: 901-226-1366
New Albany
Baptist Memorial Hospital and Cancer Center-Union County
Status: ACTIVE
Contact: Site Public Contact
Phone: 901-226-1366
Oxford
Baptist Memorial Hospital and Cancer Center-Oxford
Status: ACTIVE
Contact: Site Public Contact
Phone: 901-226-1366
Southhaven
Baptist Memorial Hospital and Cancer Center-Desoto
Status: ACTIVE
Contact: Site Public Contact
Phone: 901-226-1366

Missouri

Jefferson City
Capital Region Southwest Campus
Status: ACTIVE
Contact: Site Public Contact
Phone: 573-632-4814
Saint Louis
Missouri Baptist Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 314-996-5569
Springfield
Mercy Hospital Springfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 417-269-4520

Nebraska

Kearney
CHI Health Good Samaritan
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518

North Carolina

Asheboro
Randolph Hospital
Status: ACTIVE
Asheville
AdventHealth Infusion Center Asheville
Status: ACTIVE
Contact: Site Public Contact
Phone: 828-650-8037
Hope Women's Cancer Centers-Asheville
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 828-418-1354
Mission Hospital
Status: CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 828-418-1354
Belmont
Gaston Hematology and Oncology Associates-Belmont
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 704-865-5210
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
Status: ACTIVE
Contact: Stephen Robert Rapp
Clemmons
Wake Forest University at Clemmons
Status: ACTIVE
Contact: Site Public Contact
Phone: 888-716-9259
Clinton
Southeastern Medical Oncology Center-Clinton
Status: ACTIVE
Contact: Site Public Contact
Phone: 919-587-9084
Gastonia
CaroMont Regional Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 704-834-2810
Gaston Hematology and Oncology Associates
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 704-865-5210
Goldsboro
Southeastern Medical Oncology Center-Goldsboro
Status: ACTIVE
Contact: Site Public Contact
Phone: 919-587-9084
Greensboro
Cone Health Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 336-832-0821
Hendersonville
AdventHealth Hendersonville
Status: ACTIVE
Contact: Site Public Contact
Phone: 828-650-8037
Margaret R Pardee Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 828-696-4716
Jacksonville
Southeastern Medical Oncology Center-Jacksonville
Status: ACTIVE
Contact: Site Public Contact
Phone: 910-587-9084
Winston-Salem
Wake Forest University Health Sciences
Status: ACTIVE
Contact: Site Public Contact
Phone: 336-713-6771

North Dakota

Bismarck
Sanford Bismarck Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760
Fargo
Sanford Broadway Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-323-5760
Sanford Roger Maris Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 701-234-6161

Ohio

Belpre
Strecker Cancer Center-Belpre
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-523-3977
Cincinnati
Bethesda North Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Good Samaritan Hospital - Cincinnati
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
TriHealth Cancer Institute-Anderson
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
TriHealth Cancer Institute-Westside
Status: ACTIVE
Contact: Site Public Contact
Phone: 308-398-6518
Columbus
Columbus Oncology and Hematology Associates Inc
Status: ACTIVE
Contact: Stephen Robert Rapp
Riverside Methodist Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 614-566-4475
Findlay
Armes Family Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 937-416-9270
Marietta
Marietta Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-523-3977
Newark
Licking Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 740-348-4000

Oregon

Portland
Kaiser Permanente Northwest
Status: ACTIVE
Contact: Site Public Contact
Phone: 503-335-2400

Pennsylvania

Danville
Geisinger Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251
Hazleton
Geisinger Medical Center-Cancer Center Hazleton
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-459-2901
Lewisburg
Geisinger Medical Oncology-Lewisburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-374-8555
Pottsville
Geisinger Cancer Services-Pottsville
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-275-6401
Scranton
Community Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-703-4768
Selinsgrove
Geisinger Medical Oncology-Selinsgrove
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-374-8555
Wilkes-Barre
Geisinger Wyoming Valley / Henry Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 570-271-5251

South Carolina

Anderson
AnMed Health Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-512-4651
Easley
Prisma Health Cancer Institute - Easley
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Gaffney
Gibbs Cancer Center-Gaffney
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104
Georgetown
Tidelands Georgetown Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 843-545-5600
Greenville
Prisma Health Cancer Institute - Butternut
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Prisma Health Cancer Institute - Eastside
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Prisma Health Cancer Institute - Faris
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Greenwood
Self Regional Healthcare
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-725-4771
Greer
Gibbs Cancer Center-Pelham
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104
Prisma Health Cancer Institute - Greer
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Seneca
Prisma Health Cancer Institute - Seneca
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Spartanburg
Prisma Health Cancer Institute - Spartanburg
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-522-2066
Spartanburg Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104
Union
MGC Hematology Oncology-Union
Status: ACTIVE
Contact: Site Public Contact
Phone: 864-560-6104

South Dakota

Sioux Falls
Sanford Cancer Center Oncology Clinic
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320
Sanford USD Medical Center - Sioux Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 605-312-3320

Tennessee

Memphis
Baptist Memorial Hospital and Cancer Center-Memphis
Status: ACTIVE
Contact: Site Public Contact
Phone: 901-226-1366
Baptist Memorial Hospital for Women
Status: ACTIVE
Contact: Site Public Contact
Phone: 901-226-1366
Family Cancer Center-Memphis
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Contact: Site Public Contact
Phone: 888-823-5923
Nashville
Meharry Medical College
Status: ACTIVE
Contact: Stephen Robert Rapp

Wisconsin

Burlington
Aurora Cancer Care-Southern Lakes VLCC
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Chippewa Falls
Marshfield Clinic-Chippewa Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Eau Claire
Marshfield Medical Center-EC Cancer Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Fond Du Lac
Aurora Health Center-Fond du Lac
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Germantown
Aurora Health Care Germantown Health Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Grafton
Aurora Cancer Care-Grafton
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Green Bay
Aurora BayCare Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Saint Vincent Hospital Cancer Center Green Bay
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889
Saint Vincent Hospital Cancer Center at Saint Mary's
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889
Kenosha
Aurora Cancer Care-Kenosha South
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
La Crosse
Gundersen Lutheran Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 608-775-2385
Ladysmith
Marshfield Clinic - Ladysmith Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Manitowoc
Holy Family Memorial Hospital
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-320-2749
Marinette
Aurora Bay Area Medical Group-Marinette
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Saint Vincent Hospital Cancer Center at Marinette
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889
Marshfield
Marshfield Medical Center-Marshfield
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Milwaukee
Aurora Cancer Care-Milwaukee
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Aurora Saint Luke's Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Aurora Sinai Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Minocqua
Marshfield Clinic-Minocqua Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
New Richmond
Cancer Center of Western Wisconsin
Status: ACTIVE
Contact: Site Public Contact
Phone: 952-993-1517
Oconto Falls
Saint Vincent Hospital Cancer Center at Oconto Falls
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889
Oshkosh
Vince Lombardi Cancer Clinic - Oshkosh
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Racine
Aurora Cancer Care-Racine
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Rice Lake
Marshfield Medical Center-Rice Lake
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Sheboygan
Vince Lombardi Cancer Clinic-Sheboygan
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Stevens Point
Marshfield Clinic Stevens Point Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Sturgeon Bay
Saint Vincent Hospital Cancer Center at Sturgeon Bay
Status: ACTIVE
Contact: Site Public Contact
Phone: 920-433-8889
Summit
Aurora Medical Center in Summit
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Two Rivers
Vince Lombardi Cancer Clinic-Two Rivers
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Wausau
Marshfield Clinic-Wausau Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Wauwatosa
Aurora Cancer Care-Milwaukee West
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
West Allis
Aurora West Allis Medical Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 414-302-2304
Weston
Marshfield Clinic - Weston Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581
Wisconsin Rapids
Marshfield Clinic - Wisconsin Rapids Center
Status: ACTIVE
Contact: Site Public Contact
Phone: 800-782-8581

PRIMARY OBJECTIVES:

I. Determine whether randomization to a 24-week course of treatment with donepezil hydrochloride (donepezil) compared to placebo improves memory performance in women who have received chemotherapy for breast cancer 1 to 5 years previously.

SECONDARY OBJECTIVES:

I. Determine whether a 24-week course of treatment with donepezil compared to placebo improves executive functions (working memory, verbal fluency, set shifting), processing speed and global cognitive performance in women who have received chemotherapy for breast cancer 1 to 5 years previously.

II. Determine if a 24-week course of treatment with donepezil reduces self-reported cognitive problems in women who have received chemotherapy for breast cancer 1 to 5 years previously compared to placebo.

III. To determine the effect of a 24-week course of treatment with donepezil on toxicities and adverse events.

TERTIARY (EXPLORATORY) OBJECTIVES:

I. Determine whether apolipoprotein E (APOE) genotype (1 or 2, epsilon 4 alleles versus [v] none) is associated with poorer pre-randomization cognitive performance and more cognitive complaints in women who have received chemotherapy for breast cancer 1 to 5 years previously and to determine if APOE predicts who will respond to treatment.

II. Determine whether low cognitive reserve (CR) is associated with poorer pre-randomization cognitive performance and more cognitive complaints in women who have received chemotherapy for breast cancer 1 to 5 years previously and determine if cognitive reserve predicts who will respond to treatment.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive donepezil hydrochloride orally (PO) once daily (QD) during weeks 1-24 in the absence of unacceptable toxicity.

ARM II: Patients receive placebo PO QD during weeks 1-24 in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed up at 36 weeks.

Trial Phase Phase III

Trial Type Supportive care

Lead Organization
Wake Forest NCORP Research Base

Principal Investigator
Stephen Robert Rapp

  • Primary ID 97116
  • Secondary IDs NCI-2016-01050, WF-97116, WF-97116
  • Clinicaltrials.gov ID NCT02822573