Testing Ramipril to Prevent Memory Loss in People With Glioblastoma

February 20, 2024 updated by: Wake Forest University Health Sciences

A Single Arm, Pilot Study of Ramipril for Preventing Radiation-Induced Cognitive Decline in Glioblastoma (GBM) Patients Receiving Brain Radiotherapy

This study is to determine if an oral drug called Ramipril can lower the chance of memory loss in patients with glioblastoma getting chemoradiation. Patients will take Ramipril during chemoradiation and continue until 4 months post-treatment. Memory loss will be assessed using several neurocognitive tests throughout the duration of the study.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Drug: Ramipril

Detailed Description

This is a pilot study of an oral drug Ramipril to prevent cognitive decline in glioblastoma patients receiving partial brain radiation and concurrent and adjuvant temozolomide . Ramipril will be titrated to the highest tolerable dose during chemoradiation (2.5-5 mg). Once this dose is determined, the patient will continue at this dose for 4 months after the completion of chemoradiation. Patients will be followed until 5 months post chemoradiation for compliance, toxicity, cognitive decline and participant reported outcomes (PRO).

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Karen Craver, MT, MHA
Phone Number: 336-716-0891
Email: NCORP@wakehealth.edu

Study Locations

Guam
- - Tamuning, Guam, 96913
    - FHP Health Center-Guam
United States
- Alaska
  - Anchorage, Alaska, United States, 98508
    - Anchorage Associates in Radiation Medicine
  - Anchorage, Alaska, United States, 99508
    - Alaska Breast Care and Surgery LLC
  - Anchorage, Alaska, United States, 99508
    - Alaska Oncology and Hematology LLC
  - Anchorage, Alaska, United States, 99508
    - Alaska Women's Cancer Care
  - Anchorage, Alaska, United States, 99508
    - Anchorage Oncology Centre
  - Anchorage, Alaska, United States, 99508
    - Katmai Oncology Group
  - Anchorage, Alaska, United States, 99508
    - Providence Alaska Medical Center
  - Anchorage, Alaska, United States, 99504
    - Anchorage Radiation Therapy Center
- Arizona
  - Phoenix, Arizona, United States, 85004
    - Cancer Center at Saint Joseph's
- Arkansas
  - Fort Smith, Arkansas, United States, 72903
    - Mercy Hospital Fort Smith
  - Hot Springs, Arkansas, United States, 71913
    - CHI Saint Vincent Cancer Center Hot Springs
- California
  - Arroyo Grande, California, United States, 93420
    - Mission Hope Medical Oncology - Arroyo Grande
  - Burbank, California, United States, 91505
    - Providence Saint Joseph Medical Center/Disney Family Cancer Center
  - Irvine, California, United States, 92618
    - Aspirus Langlade Hospital
  - Los Angeles, California, United States, 90027
    - Kaiser Permanente Los Angeles Medical Center
  - Sacramento, California, United States, 95816
    - Aspirus Regional Cancer Center
  - Sacramento, California, United States, 95823
    - Aspirus Cancer Care - Wisconsin Rapids
  - San Luis Obispo, California, United States, 93401
    - Pacific Central Coast Health Center-San Luis Obispo
  - Santa Maria, California, United States, 93444
    - Mission Hope Medical Oncology - Santa Maria
- Colorado
  - Colorado Springs, Colorado, United States, 80907
    - Penrose-Saint Francis Healthcare
  - Colorado Springs, Colorado, United States, 80907
    - Rocky Mountain Cancer Centers-Penrose
  - Colorado Springs, Colorado, United States, 80923
    - Saint Francis Cancer Center
  - Columbus, Colorado, United States, 43215
    - Columbus NCI Community Oncology Research Program
  - Denver, Colorado, United States, 80210
    - Porter Adventist Hospital
  - Durango, Colorado, United States, 81301
    - Mercy Medical Center
  - Durango, Colorado, United States, 81301
    - Southwest Oncology PC
  - Lakewood, Colorado, United States, 80228
    - Saint Anthony Hospital
  - Lakewood, Colorado, United States, 80228
    - Rocky Mountain Cancer Centers-Lakewood
  - Littleton, Colorado, United States, 80122
    - Littleton Adventist Hospital
  - Longmont, Colorado, United States, 80501
    - Longmont United Hospital
  - Longmont, Colorado, United States, 80501
    - Rocky Mountain Cancer Centers-Longmont
  - Parker, Colorado, United States, 80138
    - Parker Adventist Hospital
  - Pueblo, Colorado, United States, 81004
    - Saint Mary Corwin Medical Center
  - Thornton, Colorado, United States, 80260
    - Rocky Mountain Cancer Centers-Thornton
- Delaware
  - Lewes, Delaware, United States, 19958
    - Beebe Medical Center
  - Newark, Delaware, United States, 19713
    - Helen F Graham Cancer Center
  - Newark, Delaware, United States, 19713
    - Delaware Clinical and Laboratory Physicians PA
  - Newark, Delaware, United States, 19718
    - Christiana Care Health System-Christiana Hospital
- Florida
  - Fort Lauderdale, Florida, United States, 33308
    - Holy Cross Hospital
  - Fort Myers, Florida, United States, 33905
    - Regional Cancer Center-Lee Memorial Health System
- Georgia
  - Atlanta, Georgia, United States, 30342
    - Northside Hospital
  - Atlanta, Georgia, United States, 30310
    - Carle Cancer Institute Normal
  - Duluth, Georgia, United States, 30096
    - Northside Hospital - Duluth
  - Lawrenceville, Georgia, United States, 30046
    - Northside Hospital - Gwinnett
  - Savannah, Georgia, United States, 31405
    - Lewis Cancer and Research Pavilion at Saint Joseph's/Candler
  - Snellville, Georgia, United States, 30078
    - Suburban Hematology Oncology Associates - Snellville
- Hawaii
  - 'Aiea, Hawaii, United States, 96701
    - Hawaii Cancer Care - Savio
  - 'Aiea, Hawaii, United States, 96701
    - Pali Momi Medical Center
  - 'Aiea, Hawaii, United States, 96701
    - Queen's Cancer Center - Pearlridge
  - 'Aiea, Hawaii, United States, 96701
    - The Cancer Center of Hawaii-Pali Momi
  - 'Aiea, Hawaii, United States, 96701
    - Straub Pearlridge Clinic
  - 'Aiea, Hawaii, United States, 96701
    - Hawaii Cancer Care - Westridge
  - 'Ewa Beach, Hawaii, United States, 96706
    - The Queen's Medical Center - West Oahu
  - Hilo, Hawaii, United States, 96720
    - Island Urology-Hilo
  - Honolulu, Hawaii, United States, 96813
    - Queen's Medical Center
  - Honolulu, Hawaii, United States, 96817
    - The Cancer Center of Hawaii-Liliha
  - Honolulu, Hawaii, United States, 96813
    - Hawaii Cancer Care Inc - Waterfront Plaza
  - Honolulu, Hawaii, United States, 96813
    - Queen's Cancer Cenrer - POB I
  - Honolulu, Hawaii, United States, 96813
    - Straub Clinic and Hospital
  - Honolulu, Hawaii, United States, 96813
    - University of Hawaii Cancer Center
  - Honolulu, Hawaii, United States, 96817
    - Kuakini Medical Center
  - Honolulu, Hawaii, United States, 96817
    - Queen's Cancer Center - Kuakini
  - Honolulu, Hawaii, United States, 96826
    - Kapiolani Medical Center for Women and Children
  - Honolulu, Hawaii, United States, 96813
    - Island Urology
  - Honolulu, Hawaii, United States, 96817
    - Hawaii Diagnostic Radiology Services LLC
  - Kahului, Hawaii, United States, 96732
    - Straub Medical Center - Kahului Clinic
  - Kailua, Hawaii, United States, 96734
    - Castle Medical Center
  - Lihue, Hawaii, United States, 96766
    - Wilcox Memorial Hospital and Kauai Medical Clinic
- Idaho
  - Boise, Idaho, United States, 83712
    - Saint Luke's Cancer Institute - Boise
  - Fruitland, Idaho, United States, 83619
    - Saint Luke's Cancer Institute - Fruitland
  - Meridian, Idaho, United States, 83642
    - Saint Luke's Cancer Institute - Meridian
  - Nampa, Idaho, United States, 83687
    - Saint Luke's Cancer Institute - Nampa
  - Twin Falls, Idaho, United States, 83301
    - Saint Luke's Cancer Institute - Twin Falls
- Illinois
  - Alton, Illinois, United States, 62002
    - OSF Saint Anthony's Health Center
  - Aurora, Illinois, United States, 60504
    - Rush-Copley Medical Center
  - Bloomington, Illinois, United States, 61704
    - Illinois CancerCare-Bloomington
  - Canton, Illinois, United States, 61520
    - Illinois CancerCare-Canton
  - Carbondale, Illinois, United States, 62902
    - Memorial Hospital of Carbondale
  - Carterville, Illinois, United States, 62918
    - SIH Cancer Institute
  - Carthage, Illinois, United States, 62321
    - Illinois CancerCare-Carthage
  - Centralia, Illinois, United States, 62801
    - Centralia Oncology Clinic
  - Chicago, Illinois, United States, 60612
    - John H Stroger Jr Hospital of Cook County
  - Danville, Illinois, United States, 61832
    - Carle on Vermilion
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, United States, 62526
    - Cancer Care Specialists of Illinois - Decatur
  - Decatur, Illinois, United States, 62526
    - Heartland Cancer Research NCORP
  - Dixon, Illinois, United States, 61021
    - Illinois CancerCare-Dixon
  - Effingham, Illinois, United States, 62401
    - Crossroads Cancer Center
  - Effingham, Illinois, United States, 62401
    - Carle Physician Group-Effingham
  - Eureka, Illinois, United States, 61530
    - Illinois CancerCare-Eureka
  - Galesburg, Illinois, United States, 61401
    - Western Illinois Cancer Treatment Center
  - Galesburg, Illinois, United States, 61401
    - Illinois CancerCare-Galesburg
  - Kewanee, Illinois, United States, 61443
    - Illinois CancerCare-Kewanee Clinic
  - Macomb, Illinois, United States, 61455
    - Illinois CancerCare-Macomb
  - Mattoon, Illinois, United States, 61938
    - Carle Physician Group-Mattoon/Charleston
  - Mount Vernon, Illinois, United States, 62864
    - Good Samaritan Regional Health Center
  - O'Fallon, Illinois, United States, 62269
    - Cancer Care Center of O'Fallon
  - Ottawa, Illinois, United States, 61350
    - Illinois CancerCare-Ottawa Clinic
  - Pekin, Illinois, United States, 61554
    - Illinois CancerCare-Pekin
  - Peoria, Illinois, United States, 61636
    - Methodist Medical Center of Illinois
  - Peoria, Illinois, United States, 61615
    - Illinois CancerCare-Peoria
  - Peru, Illinois, United States, 61354
    - Illinois CancerCare-Peru
  - Peru, Illinois, United States, 61354
    - Valley Radiation Oncology
  - Princeton, Illinois, United States, 61356
    - Illinois CancerCare-Princeton
  - Springfield, Illinois, United States, 62781
    - Memorial Medical Center
  - Springfield, Illinois, United States, 62702
    - Southern Illinois University School of Medicine
  - Springfield, Illinois, United States, 62702
    - Springfield Clinic
  - Springfield, Illinois, United States, 62781
    - Springfield Memorial Hospital
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center
  - Urbana, Illinois, United States, 61801
    - The Carle Foundation Hospital
  - Urbana, Illinois, United States, 61801
    - Carle Cancer Center NCI Community Oncology Research Program
  - Washington, Illinois, United States, 61571
    - Illinois CancerCare - Washington
  - Yorkville, Illinois, United States, 60560
    - Rush-Copley Healthcare Center
- Iowa
  - Carroll, Iowa, United States, 51401
    - Saint Anthony Regional Hospital
  - Cedar Rapids, Iowa, United States, 52402
    - Saint Luke's Hospital
  - Clive, Iowa, United States, 50325
    - Mercy Cancer Center-West Lakes
  - Clive, Iowa, United States, 50325
    - Medical Oncology and Hematology Associates-West Des Moines
  - Council Bluffs, Iowa, United States, 51503
    - Alegent Health Mercy Hospital
  - Creston, Iowa, United States, 50801
    - Greater Regional Medical Center
  - Des Moines, Iowa, United States, 50309
    - Iowa Methodist Medical Center
  - Des Moines, Iowa, United States, 50314
    - Mercy Medical Center - Des Moines
  - Des Moines, Iowa, United States, 50309
    - Medical Oncology and Hematology Associates-Des Moines
  - Des Moines, Iowa, United States, 50314
    - Broadlawns Medical Center
  - Des Moines, Iowa, United States, 50316
    - Iowa Lutheran Hospital
  - Des Moines, Iowa, United States, 50309
    - Iowa-Wide Oncology Research Coalition NCORP
  - Des Moines, Iowa, United States, 50314
    - Medical Oncology and Hematology Associates-Laurel
  - Fort Dodge, Iowa, United States, 50501
    - Trinity Regional Medical Center
  - West Des Moines, Iowa, United States, 50266-7700
    - Methodist West Hospital
  - West Des Moines, Iowa, United States, 50266
    - Mercy Medical Center-West Lakes
- Kansas
  - Garden City, Kansas, United States, 67846
    - Central Care Cancer Center - Garden City
  - Great Bend, Kansas, United States, 67530
    - Central Care Cancer Center - Great Bend
  - Lawrence, Kansas, United States, 66044
    - Lawrence Memorial Hospital
  - Wichita, Kansas, United States, 67214
    - Ascension Via Christi Hospitals Wichita
  - Wichita, Kansas, United States, 67208
    - Cancer Center of Kansas-Wichita Medical Arts Tower
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas - Wichita
- Kentucky
  - Bardstown, Kentucky, United States, 40004
    - Flaget Memorial Hospital
  - Corbin, Kentucky, United States, 40701
    - Commonwealth Cancer Center-Corbin
  - Lexington, Kentucky, United States, 40504
    - Saint Joseph Radiation Oncology Resource Center
  - Lexington, Kentucky, United States, 40509
    - Saint Joseph Hospital East
  - London, Kentucky, United States, 40741
    - Saint Joseph London
  - Louisville, Kentucky, United States, 40202
    - Jewish Hospital
  - Louisville, Kentucky, United States, 40245
    - UofL Health Medical Center Northeast
  - Louisville, Kentucky, United States, 40215
    - Saints Mary and Elizabeth Hospital
  - Shepherdsville, Kentucky, United States, 40165
    - Jewish Hospital Medical Center South
- Louisiana
  - Marrero, Louisiana, United States, 70072
    - West Jefferson Medical Center
  - Marrero, Louisiana, United States, 70072
    - Culicchia Neurological Clinic LLC
  - New Orleans, Louisiana, United States, 70112
    - University Medical Center New Orleans
  - New Orleans, Louisiana, United States, 70112
    - Louisiana State University Health Science Center
  - Shreveport, Louisiana, United States, 71103
    - LSU Health Sciences Center at Shreveport
- Michigan
  - Ann Arbor, Michigan, United States, 48106
    - Saint Joseph Mercy Hospital
  - Ann Arbor, Michigan, United States, 48106
    - Michigan Cancer Research Consortium NCORP
  - Battle Creek, Michigan, United States, 49017
    - Bronson Battle Creek
  - Brighton, Michigan, United States, 48114
    - Saint Joseph Mercy Brighton
  - Brighton, Michigan, United States, 48114
    - IHA Hematology Oncology Consultants-Brighton
  - Canton, Michigan, United States, 48188
    - Saint Joseph Mercy Canton
  - Canton, Michigan, United States, 48188
    - IHA Hematology Oncology Consultants-Canton
  - Caro, Michigan, United States, 48723
    - Caro Cancer Center
  - Chelsea, Michigan, United States, 48118
    - Saint Joseph Mercy Chelsea
  - Chelsea, Michigan, United States, 48118
    - IHA Hematology Oncology Consultants-Chelsea
  - Clarkston, Michigan, United States, 48346
    - Hematology Oncology Consultants-Clarkston
  - Clarkston, Michigan, United States, 48346
    - Newland Medical Associates-Clarkston
  - Detroit, Michigan, United States, 48236
    - Ascension Saint John Hospital
  - East China Township, Michigan, United States, 48054
    - Great Lakes Cancer Management Specialists-Doctors Park
  - Flint, Michigan, United States, 48503
    - Hurley Medical Center
  - Flint, Michigan, United States, 48503
    - Genesee Cancer and Blood Disease Treatment Center
  - Flint, Michigan, United States, 48503
    - Genesee Hematology Oncology PC
  - Flint, Michigan, United States, 48503
    - Genesys Hurley Cancer Institute
  - Grand Rapids, Michigan, United States, 49503
    - Spectrum Health at Butterworth Campus
  - Grand Rapids, Michigan, United States, 49503
    - Helen DeVos Children's Hospital at Spectrum Health
  - Grand Rapids, Michigan, United States, 49503
    - Mercy Health Saint Mary's
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Academic Hematology Oncology Specialists
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Great Lakes Cancer Management Specialists-Van Elslander Cancer Center
  - Grosse Pointe Woods, Michigan, United States, 48236
    - Michigan Breast Specialists-Grosse Pointe Woods
  - Kalamazoo, Michigan, United States, 49007
    - West Michigan Cancer Center
  - Kalamazoo, Michigan, United States, 49007
    - Bronson Methodist Hospital
  - Kalamazoo, Michigan, United States, 49048
    - Borgess Medical Center
  - Lansing, Michigan, United States, 48912
    - Sparrow Hospital
  - Livonia, Michigan, United States, 48154
    - Saint Mary Mercy Hospital
  - Macomb, Michigan, United States, 48044
    - Great Lakes Cancer Management Specialists-Macomb Medical Campus
  - Macomb, Michigan, United States, 48044
    - Michigan Breast Specialists-Macomb Township
  - Marlette, Michigan, United States, 48453
    - Saint Mary's Oncology/Hematology Associates of Marlette
  - Muskegon, Michigan, United States, 49444
    - Mercy Health Mercy Campus
  - Niles, Michigan, United States, 49120
    - Lakeland Hospital Niles
  - Norton Shores, Michigan, United States, 49444
    - Cancer and Hematology Centers of Western Michigan - Norton Shores
  - Oshtemo, Michigan, United States, 49008
    - Ascension Borgess Cancer Center
  - Pontiac, Michigan, United States, 48341
    - Saint Joseph Mercy Oakland
  - Pontiac, Michigan, United States, 48341
    - 21st Century Oncology-Pontiac
  - Pontiac, Michigan, United States, 48341
    - Hope Cancer Center
  - Pontiac, Michigan, United States, 48341
    - Newland Medical Associates-Pontiac
  - Reed City, Michigan, United States, 49677
    - Spectrum Health Reed City Hospital
  - Saginaw, Michigan, United States, 48601
    - Ascension Saint Mary's Hospital
  - Saginaw, Michigan, United States, 48604
    - Oncology Hematology Associates of Saginaw Valley PC
  - Saint Joseph, Michigan, United States, 49085
    - Lakeland Medical Center Saint Joseph
  - Saint Joseph, Michigan, United States, 49085
    - Marie Yeager Cancer Center
  - Sterling Heights, Michigan, United States, 48312
    - Bhadresh Nayak MD PC-Sterling Heights
  - Tawas City, Michigan, United States, 48764
    - Ascension Saint Joseph Hospital
  - Traverse City, Michigan, United States, 49684
    - Munson Medical Center
  - Warren, Michigan, United States, 48093
    - Saint John Macomb-Oakland Hospital
  - Warren, Michigan, United States, 48088
    - Advanced Breast Care Center PLLC
  - Warren, Michigan, United States, 48093
    - Great Lakes Cancer Management Specialists-Macomb Professional Building
  - Warren, Michigan, United States, 48093
    - Macomb Hematology Oncology PC
  - Warren, Michigan, United States, 48093
    - Michigan Breast Specialists-Warren
  - West Branch, Michigan, United States, 48661
    - Saint Mary's Oncology/Hematology Associates of West Branch
  - Wyoming, Michigan, United States, 49519
    - Metro Health Hospital
  - Ypsilanti, Michigan, United States, 48106
    - Huron Gastroenterology PC
  - Ypsilanti, Michigan, United States, 48197
    - IHA Hematology Oncology Consultants-Ann Arbor
- Minnesota
  - Aitkin, Minnesota, United States, 56431
    - Riverwood Healthcare Center
  - Bemidji, Minnesota, United States, 56601
    - Sanford Joe Lueken Cancer Center
  - Brainerd, Minnesota, United States, 56401
    - Essentia Health Saint Joseph's Medical Center
  - Burnsville, Minnesota, United States, 55337
    - Fairview Ridges Hospital
  - Burnsville, Minnesota, United States, 55337
    - Minnesota Oncology - Burnsville
  - Cambridge, Minnesota, United States, 55008
    - Cambridge Medical Center
  - Coon Rapids, Minnesota, United States, 55433
    - Mercy Hospital
  - Deer River, Minnesota, United States, 56636
    - Essentia Health - Deer River Clinic
  - Detroit Lakes, Minnesota, United States, 56501
    - Essentia Health Saint Mary's - Detroit Lakes Clinic
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Cancer Center
  - Duluth, Minnesota, United States, 55805
    - Essentia Health Saint Mary's Medical Center
  - Duluth, Minnesota, United States, 55805
    - Miller-Dwan Hospital
  - Edina, Minnesota, United States, 55435
    - Fairview Southdale Hospital
  - Fergus Falls, Minnesota, United States, 56537
    - Lake Region Healthcare Corporation-Cancer Care
  - Fosston, Minnesota, United States, 56542
    - Essentia Health - Fosston
  - Fridley, Minnesota, United States, 55432
    - Unity Hospital
  - Hibbing, Minnesota, United States, 55746
    - Essentia Health Hibbing Clinic
  - Maple Grove, Minnesota, United States, 55369
    - Fairview Clinics and Surgery Center Maple Grove
  - Maplewood, Minnesota, United States, 55109
    - Saint John's Hospital - Healtheast
  - Maplewood, Minnesota, United States, 55109
    - Minnesota Oncology Hematology PA-Maplewood
  - Minneapolis, Minnesota, United States, 55415
    - Hennepin County Medical Center
  - Minneapolis, Minnesota, United States, 55407
    - Abbott-Northwestern Hospital
  - Minneapolis, Minnesota, United States, 55454
    - Health Partners Inc
  - Monticello, Minnesota, United States, 55362
    - Monticello Cancer Center
  - New Ulm, Minnesota, United States, 56073
    - New Ulm Medical Center
  - Park Rapids, Minnesota, United States, 56470
    - Essentia Health - Park Rapids
  - Princeton, Minnesota, United States, 55371
    - Fairview Northland Medical Center
  - Robbinsdale, Minnesota, United States, 55422
    - North Memorial Medical Health Center
  - Saint Louis Park, Minnesota, United States, 55416
    - Park Nicollet Clinic - Saint Louis Park
  - Saint Paul, Minnesota, United States, 55101
    - Regions Hospital
  - Saint Paul, Minnesota, United States, 55102
    - United Hospital
  - Sandstone, Minnesota, United States, 55072
    - Essentia Health Sandstone
  - Shakopee, Minnesota, United States, 55379
    - Saint Francis Regional Medical Center
  - Stillwater, Minnesota, United States, 55082
    - Lakeview Hospital
  - Thief River Falls, Minnesota, United States, 56701
    - Sanford Thief River Falls Medical Center
  - Virginia, Minnesota, United States, 55792
    - Essentia Health Virginia Clinic
  - Waconia, Minnesota, United States, 55387
    - Ridgeview Medical Center
  - Willmar, Minnesota, United States, 56201
    - Rice Memorial Hospital
  - Woodbury, Minnesota, United States, 55125
    - Minnesota Oncology Hematology PA-Woodbury
  - Worthington, Minnesota, United States, 56187
    - Sanford Cancer Center Worthington
  - Wyoming, Minnesota, United States, 55092
    - Fairview Lakes Medical Center
- Missouri
  - Ballwin, Missouri, United States, 63011
    - Saint Louis Cancer and Breast Institute-Ballwin
  - Bolivar, Missouri, United States, 65613
    - Central Care Cancer Center - Bolivar
  - Branson, Missouri, United States, 65616
    - Cox Cancer Center Branson
  - Cape Girardeau, Missouri, United States, 63703
    - Saint Francis Medical Center
  - Cape Girardeau, Missouri, United States, 63703
    - Southeast Cancer Center
  - Farmington, Missouri, United States, 63640
    - Parkland Health Center - Farmington
  - Jefferson City, Missouri, United States, 65109
    - Capital Region Southwest Campus
  - Joplin, Missouri, United States, 64804
    - Freeman Health System
  - Joplin, Missouri, United States, 64804
    - Mercy Hospital Joplin
  - Rolla, Missouri, United States, 65401
    - Delbert Day Cancer Institute at PCRMC
  - Rolla, Missouri, United States, 65401
    - Mercy Clinic-Rolla-Cancer and Hematology
  - Saint Joseph, Missouri, United States, 64506
    - Heartland Regional Medical Center
  - Saint Louis, Missouri, United States, 63131
    - Missouri Baptist Medical Center
  - Saint Louis, Missouri, United States, 63141
    - Mercy Hospital Saint Louis
  - Saint Louis, Missouri, United States, 63128
    - Mercy Hospital South
  - Saint Louis, Missouri, United States, 63109
    - Saint Louis Cancer and Breast Institute-South City
  - Sainte Genevieve, Missouri, United States, 63670
    - Sainte Genevieve County Memorial Hospital
  - Springfield, Missouri, United States, 65807
    - CoxHealth South Hospital
  - Springfield, Missouri, United States, 65804
    - Mercy Hospital Springfield
  - Sullivan, Missouri, United States, 63080
    - Missouri Baptist Sullivan Hospital
  - Sunset Hills, Missouri, United States, 63127
    - Missouri Baptist Outpatient Center-Sunset Hills
  - Washington, Missouri, United States, 63090
    - Mercy Hospital Washington
- Montana
  - Missoula, Montana, United States, 59802
    - Saint Patrick Hospital - Community Hospital
- Nebraska
  - Grand Island, Nebraska, United States, 68803
    - Nebraska Cancer Specialists/Oncology Hematology West PC
  - Kearney, Nebraska, United States, 68847
    - CHI Health Good Samaritan
  - Lincoln, Nebraska, United States, 68510
    - Saint Elizabeth Regional Medical Center
  - Omaha, Nebraska, United States, 68124
    - Alegent Health Bergan Mercy Medical Center
  - Omaha, Nebraska, United States, 68122
    - Alegent Health Immanuel Medical Center
  - Omaha, Nebraska, United States, 68130
    - Alegent Health Lakeside Hospital
  - Omaha, Nebraska, United States, 68131
    - Creighton University Medical Center
  - Papillion, Nebraska, United States, 68046
    - Midlands Community Hospital
- New Jersey
  - Cape May Court House, New Jersey, United States, 08210
    - AtlantiCare Health Park-Cape May Court House
  - Egg Harbor Township, New Jersey, United States, 08234
    - AtlantiCare Surgery Center
- New Mexico
  - Albuquerque, New Mexico, United States, 87102
    - University of New Mexico Cancer Center
  - Albuquerque, New Mexico, United States, 87102
    - Lovelace Medical Center-Saint Joseph Square
  - Albuquerque, New Mexico, United States, 87109
    - Lovelace Radiation Oncology
  - Albuquerque, New Mexico, United States, 87102
    - Lovelace Medical Center-Downtown
- New York
  - Bay Shore, New York, United States, 11706
    - Northwell Health Imbert Cancer Center
  - Lake Success, New York, United States, 11042
    - Northwell Health/Center for Advanced Medicine
- North Carolina
  - Asheboro, North Carolina, United States, 27203
    - Randolph Hospital
  - Asheboro, North Carolina, United States, 27203
    - Cone Health Cancer Center at Asheboro
  - Asheville, North Carolina, United States, 28801
    - Mission Hospital
  - Burlington, North Carolina, United States, 27215
    - Cone Health Cancer Center at Alamance Regional
  - Clemmons, North Carolina, United States, 27012
    - Wake Forest University at Clemmons
  - Greensboro, North Carolina, United States, 27403
    - Cone Health Cancer Center
  - Greensboro, North Carolina, United States, 27403
    - Novant Health Breast Surgery - Greensboro
  - Greensboro, North Carolina, United States, 27401
    - Central Carolina Surgery
  - Hendersonville, North Carolina, United States, 28791
    - Margaret R Pardee Memorial Hospital
  - Kernersville, North Carolina, United States, 27284
    - Novant Health Cancer Institute - Kernersville
  - Mebane, North Carolina, United States, 27302
    - Cone Heath Cancer Center at Mebane
  - Mount Airy, North Carolina, United States, 27030
    - Novant Health Cancer Institute - Mount Airy
  - Reidsville, North Carolina, United States, 27320
    - Annie Penn Memorial Hospital
  - Statesville, North Carolina, United States, 28625
    - Novant Health Cancer Institute - Statesville
  - Thomasville, North Carolina, United States, 27360
    - Novant Health Cancer Institute - Thomasville
  - Wilkesboro, North Carolina, United States, 28659
    - Novant Health Cancer Institute - Wilkesboro
  - Wilkesboro, North Carolina, United States, 28659
    - Wake Forest Baptist Health - Wilkes Medical Center
  - Winston-Salem, North Carolina, United States, 27157
    - Wake Forest University Health Sciences
  - Winston-Salem, North Carolina, United States, 27103
    - Novant Health Forsyth Medical Center
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Sanford Bismarck Medical Center
  - Fargo, North Dakota, United States, 58122
    - Sanford Roger Maris Cancer Center
  - Fargo, North Dakota, United States, 58103
    - Essentia Health Cancer Center-South University Clinic
  - Fargo, North Dakota, United States, 58122
    - Sanford Broadway Medical Center
  - Fargo, North Dakota, United States, 58103
    - Sanford South University Medical Center
  - Fargo, North Dakota, United States, 58103
    - Southpointe-Sanford Medical Center Fargo
  - Fargo, North Dakota, United States, 58104
    - Sanford Medical Center Fargo
  - Jamestown, North Dakota, United States, 58401
    - Essentia Health - Jamestown Clinic
- Ohio
  - Belpre, Ohio, United States, 45714
    - Strecker Cancer Center-Belpre
  - Chillicothe, Ohio, United States, 45601
    - Adena Regional Medical Center
  - Cincinnati, Ohio, United States, 45220
    - Good Samaritan Hospital - Cincinnati
  - Cincinnati, Ohio, United States, 45242
    - Bethesda North Hospital
  - Cincinnati, Ohio, United States, 45247
    - TriHealth Cancer Institute-Westside
  - Cincinnati, Ohio, United States, 45255
    - TriHealth Cancer Institute-Anderson
  - Columbus, Ohio, United States, 43214
    - Riverside Methodist Hospital
  - Columbus, Ohio, United States, 43219
    - The Mark H Zangmeister Center
  - Columbus, Ohio, United States, 43214
    - Columbus Oncology and Hematology Associates Inc
  - Columbus, Ohio, United States, 43228
    - Doctors Hospital
  - Columbus, Ohio, United States, 43213
    - Mount Carmel East Hospital
  - Columbus, Ohio, United States, 43215
    - Grant Medical Center
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health Center West
  - Delaware, Ohio, United States, 43015
    - Delaware Health Center-Grady Cancer Center
  - Delaware, Ohio, United States, 43015
    - Grady Memorial Hospital
  - Dublin, Ohio, United States, 43016
    - Dublin Methodist Hospital
  - Dublin, Ohio, United States, 43016
    - Columbus Oncology and Hematology Associates
  - Gahanna, Ohio, United States, 43230
    - Central Ohio Breast and Endocrine Surgery
  - Grove City, Ohio, United States, 43123
    - Mount Carmel Grove City Hospital
  - Lancaster, Ohio, United States, 43130
    - Fairfield Medical Center
  - Lima, Ohio, United States, 45801
    - Saint Rita's Medical Center
  - Mansfield, Ohio, United States, 44903
    - OhioHealth Mansfield Hospital
  - Marietta, Ohio, United States, 45750
    - Marietta Memorial Hospital
  - Marion, Ohio, United States, 43302
    - OhioHealth Marion General Hospital
  - Mount Vernon, Ohio, United States, 43050
    - Knox Community Hospital
  - Newark, Ohio, United States, 43055
    - Licking Memorial Hospital
  - Newark, Ohio, United States, 43055
    - Newark Radiation Oncology
  - Perrysburg, Ohio, United States, 43551
    - Mercy Health - Perrysburg Hospital
  - Portsmouth, Ohio, United States, 45662
    - Southern Ohio Medical Center
  - Toledo, Ohio, United States, 43623
    - Mercy Health - Saint Anne Hospital
  - Toledo, Ohio, United States, 43608
    - Mercy Health - Saint Vincent Hospital
  - Toledo, Ohio, United States, 43623
    - Mercy Health Sylvania Radiation Oncology Center
  - Westerville, Ohio, United States, 43081
    - Saint Ann's Hospital
  - Zanesville, Ohio, United States, 43701
    - Genesis Healthcare System Cancer Care Center
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73120
    - Mercy Hospital Oklahoma City
- Oregon
  - Bend, Oregon, United States, 97701
    - Saint Charles Health System
  - Clackamas, Oregon, United States, 97015
    - Clackamas Radiation Oncology Center
  - Clackamas, Oregon, United States, 97015
    - Providence Cancer Institute Clackamas Clinic
  - Coos Bay, Oregon, United States, 97420
    - Bay Area Hospital
  - Newberg, Oregon, United States, 97132
    - Providence Newberg Medical Center
  - Portland, Oregon, United States, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - Providence Saint Vincent Medical Center
  - Redmond, Oregon, United States, 97756
    - Saint Charles Health System-Redmond
- Pennsylvania
  - Allentown, Pennsylvania, United States, 18103
    - Lehigh Valley Hospital-Cedar Crest
  - Bethlehem, Pennsylvania, United States, 18017
    - Lehigh Valley Hospital - Muhlenberg
  - Chadds Ford, Pennsylvania, United States, 19317
    - Christiana Care Health System-Concord Health Center
  - Danville, Pennsylvania, United States, 17822
    - Geisinger Medical Center
  - East Stroudsburg, Pennsylvania, United States, 18301
    - Pocono Medical Center
  - Hazleton, Pennsylvania, United States, 18201
    - Lehigh Valley Hospital-Hazelton
  - Lewisburg, Pennsylvania, United States, 17837
    - Geisinger Medical Oncology-Lewisburg
  - Paoli, Pennsylvania, United States, 19301
    - Paoli Memorial Hospital
  - Wilkes-Barre, Pennsylvania, United States, 18711
    - Geisinger Wyoming Valley/Henry Cancer Center
  - Wynnewood, Pennsylvania, United States, 19096
    - Lankenau Medical Center
- South Carolina
  - Bluffton, South Carolina, United States, 29910
    - Saint Joseph's/Candler - Bluffton Campus
  - Boiling Springs, South Carolina, United States, 29316
    - Prisma Health Cancer Institute - Spartanburg
  - Charleston, South Carolina, United States, 29425
    - Medical University of South Carolina
  - Easley, South Carolina, United States, 29640
    - Prisma Health Cancer Institute - Easley
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Cancer Institute - Faris
  - Greenville, South Carolina, United States, 29615
    - Prisma Health Cancer Institute - Eastside
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Cancer Institute - Butternut
  - Greenville, South Carolina, United States, 29605
    - Prisma Health Greenville Memorial Hospital
  - Greer, South Carolina, United States, 29650
    - Prisma Health Cancer Institute - Greer
  - Hilton Head Island, South Carolina, United States, 29926
    - The Radiation Oncology Center-Hilton Head/Bluffton
  - Hilton Head Island, South Carolina, United States, 29926-3827
    - South Carolina Cancer Specialists PC
  - Seneca, South Carolina, United States, 29672
    - Prisma Health Cancer Institute - Seneca
- South Dakota
  - Sioux Falls, South Dakota, United States, 57117-5134
    - Sanford USD Medical Center - Sioux Falls
  - Sioux Falls, South Dakota, United States, 57104
    - Sanford Cancer Center Oncology Clinic
- Texas
  - Bryan, Texas, United States, 77802
    - Saint Joseph Regional Cancer Center
- Washington
  - Aberdeen, Washington, United States, 98520
    - Providence Regional Cancer System-Aberdeen
  - Bellingham, Washington, United States, 98225
    - PeaceHealth Saint Joseph Medical Center
  - Bremerton, Washington, United States, 98310
    - Saint Michael Cancer Center
  - Burien, Washington, United States, 98166
    - Highline Medical Center-Main Campus
  - Centralia, Washington, United States, 98531
    - Providence Regional Cancer System-Centralia
  - Edmonds, Washington, United States, 98026
    - Swedish Cancer Institute-Edmonds
  - Enumclaw, Washington, United States, 98022
    - Saint Elizabeth Hospital
  - Everett, Washington, United States, 98201
    - Providence Regional Cancer Partnership
  - Federal Way, Washington, United States, 98003
    - Saint Francis Hospital
  - Issaquah, Washington, United States, 98029
    - Swedish Cancer Institute-Issaquah
  - Kennewick, Washington, United States, 99336
    - Kadlec Clinic Hematology and Oncology
  - Lakewood, Washington, United States, 98499
    - Saint Clare Hospital
  - Longview, Washington, United States, 98632
    - PeaceHealth Saint John Medical Center
  - Seattle, Washington, United States, 98107
    - Swedish Medical Center-Ballard Campus
  - Seattle, Washington, United States, 98122-4307
    - Swedish Medical Center-First Hill
  - Seattle, Washington, United States, 98122-5711
    - Swedish Medical Center-Cherry Hill
  - Sedro-Woolley, Washington, United States, 98284
    - PeaceHealth United General Medical Center
  - Shelton, Washington, United States, 98584
    - Providence Regional Cancer System-Shelton
  - Vancouver, Washington, United States, 98664
    - PeaceHealth Southwest Medical Center
  - Walla Walla, Washington, United States, 99362
    - Providence Saint Mary Regional Cancer Center
  - Yelm, Washington, United States, 98597
    - Providence Regional Cancer System-Yelm
- Wisconsin
  - Antigo, Wisconsin, United States, 54409
    - Aspirus Langlade Hospital
  - Ashland, Wisconsin, United States, 54806
    - Duluth Clinic Ashland
  - Ashland, Wisconsin, United States, 54806
    - Northwest Wisconsin Cancer Center
  - Chippewa Falls, Wisconsin, United States, 54729
    - Marshfield Clinic-Chippewa Center
  - Eau Claire, Wisconsin, United States, 54701
    - Marshfield Medical Center-EC Cancer Center
  - La Crosse, Wisconsin, United States, 54601
    - Gundersen Lutheran Medical Center
  - Ladysmith, Wisconsin, United States, 54848
    - Marshfield Clinic - Ladysmith Center
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Medical Center-Marshfield
  - Medford, Wisconsin, United States, 54451
    - Aspirus Medford Hospital
  - Milwaukee, Wisconsin, United States, 53215
    - Aurora Saint Luke's Medical Center
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic-Minocqua Center
  - New Richmond, Wisconsin, United States, 54017
    - Cancer Center of Western Wisconsin
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Medical Center-Rice Lake
  - Stevens Point, Wisconsin, United States, 54482
    - Marshfield Clinic Stevens Point Center
  - Wausau, Wisconsin, United States, 54401
    - Aspirus Regional Cancer Center
  - Wausau, Wisconsin, United States, 54401
    - Marshfield Clinic-Wausau Center
  - Weston, Wisconsin, United States, 54476
    - Marshfield Medical Center - Weston
  - Weston, Wisconsin, United States, 54476
    - Diagnostic and Treatment Center
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Aspirus Cancer Care - Wisconsin Rapids
  - Wisconsin Rapids, Wisconsin, United States, 54494
    - Marshfield Clinic - Wisconsin Rapids Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Histologically proven diagnosis of glioblastoma or gliosarcoma (World Health Organization [WHO] grade IV) obtained at the time of a partial or gross total resection of the tumor. Patients who undergo a stereotactic needle biopsy alone are not eligible.
The tumor must have a supratentorial component.
History/physical examination within 14 days prior to enrollment.
The patient must have recovered from the effects of surgery, postoperative infection, and other complications before enrollment
Patient planning to receive brain RT, and concurrent and adjuvant temozolomide chemotherapy for six weeks as per standard of care therapy. Use of the Optune® (also known as Tumor Treating Fields or TTFields) device is allowed at provider discretion, but must begin after the Month 1 Post RT (10 week [wk]) Neurocognitive-PRO assessment.
Study drug (Ramipril) must be given >= 21 days and ≤ 42 days after surgery.
All available brain magnetic resonance imaging (MRI) or computed tomography (CT) imaging reports from surgery to study completion must be submitted. This includes any post-operative or pre-radiation scan reports.
Eastern Cooperative Oncology Group (ECOG) 0, 1 or 2
Absolute neutrophil count (ANC) >= 1,500 cells/mm^3 (obtained within 14 days prior to enrollment)
Platelets >= 100,000 cells/mm^3 (obtained within 14 days prior to enrollment)
Hemoglobin >= 10.0 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobin [Hgb] >= 10.0 g/dl is acceptable) (obtained within 14 days prior to enrollment)
Blood urea nitrogen (BUN) =< 30 mg/dl within 14 days prior to enrollment
Creatinine =< 1.7 mg/dl within 14 days prior to enrollment
Total bilirubin =< 2.0 mg/dl within 14 days prior to enrollment
Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) =< 3 x normal range within 14 days prior to enrollment
Patient must provide study specific informed consent prior to study entry
Baseline potassium level <5.0 mEq/L. High potassium values that are thought to be a result of sample hemolysis may be repeated to determine an accurate potassium level and to determine potential study eligibility. Likewise high potassium values thought to be a result of potassium supplementation may be repeated at an appropriate time (5 half-lives after supplement discontinuation) to determine potential study eligibility.

Patient must be able to complete neurocognitive tests in the English language

Women of childbearing potential and male participants must practice adequate contraception
For females of child-bearing potential, negative serum or urine pregnancy test within 14 days of enrollment
Local site must be follow the standard GBM radiation treatment dosimetry plan
For patients who will be treated with the Optune® device in addition to standard of care radiation plus concurrent and adjuvant temozolomide, the following inclusion criteria also apply:
Patients must have only a supratentorial glioblastoma
The treating physician must be a qualified provider having successfully completed the training course provided by Novocure, the device manufacturer
Patients with prior malignancies if all treatment for that malignancy was completed at least 2 years before registration and the patient has no evidence of disease.

Exclusion Criteria:

Prior allergic reaction or intolerance to angiotensin-converting-enzyme (ACE) inhibitor
Hypotension (< 110 mg Hg systolic) at the time of enrollment
Renal insufficiency with creatinine clearance of < 40 ml/min (at time of enrollment)
Solitary kidney or known renal artery stenosis
Current ACE inhibitor or angiotensin receptor blocker use. Patients can come off ACE inhibitors or angiotensin receptor blockers for 1 week to be eligible for this study.
Prior invasive malignancy (except for non-melanomatous skin cancer) unless disease free for ≥ 2 years. (For example, carcinoma in situ of the breast, oral cavity, and cervix are all permissible).
Recurrent or multifocal malignant gliomas
Metastases detected below the tentorium or beyond the cranial vault
Prior chemotherapy or radiosensitizers for cancers of the head and neck region; note that prior chemotherapy for a different cancer is allowable, except prior temozolomide. Prior use of Gliadel wafers or any other intratumoral or intracavitary treatment are not permitted.
Prior radiotherapy to the head or neck (except for T1 glottic cancer), resulting in overlap of radiation fields.
Severe active co-morbidity, defined as follows:
Acute bacterial or fungal infection requiring intravenous antibiotics at the time of enrollment
Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of enrollment.
Known HIV positivity or acquired immune deficiency syndrome (AIDS) based upon current CDC definition; note, however, that HIV testing is not required for entry into this protocol. The need to exclude patients with AIDS from this protocol is necessary because the treatments involved in this protocol may be significantly immunosuppressive.
Active connective tissue disorders, such as lupus or scleroderma, that in the opinion of the treating physician may put the patient at high risk for radiation toxicity.
Any other major medical illnesses or psychiatric impairments that in the investigator's opinion will prevent administration or completion of protocol therapy.
Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception; this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
Patients treated on any other therapeutic clinical protocols within 30 days prior to study entry or during participation in the study unless they involve standard of care or over the counter therapies or do not involve a drug therapy.
Patients planning to receive therapeutic antitumor agents (excluding use of the Tumor Treating Fields (TTFields or Optune®) device after the Month 1 Post RT (10 wk) Neurocognitive-PRO assessment.) in addition to standard radiation and concurrent and adjuvant temozolomide are not eligible to participate in this study.
Patients with impaired decision-making capacity; this exclusion is necessary because such patients may not be able to adequately give informed consent.
Pregnant or lactating women, due to possible adverse effect on the developing fetus or infant due to study drug.
For patients who will be treated with the Optune® device in addition to standard of care radiation plus concurrent and adjuvant temozolomide, the following exclusion criteria also apply:
Optune® is not permitted in patients who have an active implanted medical device, skull defect (such as, missing bone with no replacement) or bullet fragments. Examples of active electronic devices include deep brain stimulators, spinal cord stimulators, vagus nerve stimulators, pacemakers, defibrillators, and programmatic shunts.
Optune® is not permitted in patients who are known to be sensitive to conductive hydrogels. Examples of conductive hydrogels are gels used on electrocardiogram (ECG) stickers or transcutaneous electrical nerve stimulation (TENS) electrodes.
Patients being treated with Memantine, Donepezil, and/or medications prescribed to enhance cognition.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Supportive Care
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ramipril Ramipril will be taken once daily by mouth. It will be titrated during the first 3 weeks of chemoradiation to the highest tolerable dose (2.5-5 mg). This dose will be taken each day until 4 months post-chemoradiation treatment (22 weeks).	Drug: Ramipril 2.5 - 5 mg oral, 1x daily for 22 weeks Other Names: Altace Tritace

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Neurocognitive Function at 10 weeks - Hopkins Verbal Learning Test-Revised (HVLT-R) Time Frame: Baseline,10 weeks	HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R.	Baseline,10 weeks
Change from Baseline Neurocognitive Function at 10 weeks - Trail Making Test Part A and B (TMT A & B) Time Frame: Baseline,10 weeks	Part A of the TMT measures attention and visual motor skills and processing speed and requires subjects to connect 25 numbered circles in the proper sequence (1-2-3-…) as quickly as possible. TMT-B is similar except subjects are required to connect dots in an alternating numerical and alphabetical sequence (1-A-2-B-…). TMT-B with its added complexity and set shifting requirements is a widely used measure of executive function. The score for TMT-A and TMT-B is the total time in seconds required to complete the task. Scores can also be generated for number of errors and number of circles correctly connected.	Baseline,10 weeks
Change from Baseline Neurocognitive Function at 10 weeks - Controlled Oral Word Association Test (COWA) Time Frame: Baseline,10 weeks	The COWA measures speed of mental processing, verbal fluency, and executive function. Subjects are asked to name as many words as possible all beginning with a specified letter. A total of three trials are administered, each with a different letter (F-A-S). The score on the COWA is the total number of words named across the three trials minus repetitions.	Baseline,10 weeks
Efficacy of Ramipril of Neurocognitive Function at Baseline - Shipley Institute of Living Scale-Version 2 Vocabulary Time Frame: Baseline	Provides an assessment of premorbid intellectual functioning comparable to a verbal IQ and thus is a proxy for cognitive reserve. This vocabulary test requires respondents to read a target word and select one of four words that most closely means the same thing. Score is total correct of 40 items and will be used in conjunction with the other neurocognitive results.	Baseline
Retention Rate at 10 weeks Time Frame: 10 weeks	Measured by the percent of patients who took 75% of the Ramipril doses and completed the neurocognitive battery of tests	10 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) Time Frame: Baseline, 6 weeks, 10 weeks, 22 weeks	A 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All of the scales and single-item measures range in score from 0 to 100 with standardization.	Baseline, 6 weeks, 10 weeks, 22 weeks
Estimate Time of Neurocognitive Decline- HVLT-R Time Frame: Baseline - 22 weeks	Measured by the first significant decline of the HVLT-R.	Baseline - 22 weeks
Estimate Time of Neurocognitive Decline- TMT A & B Time Frame: Baseline - 22 weeks	Measured by the first significant decline of the TMT A & B	Baseline - 22 weeks
Estimate Time of Neurocognitive Decline- COWA Time Frame: Baseline - 22 weeks	Measured by the first significant decline of the COWA	Baseline - 22 weeks
Determine Presence of Apolipoprotein Epsilon (ApoE) Time Frame: Baseline	Measured by quantitative polymerase chain reaction (PCR) using patient serum via a blood test	Baseline
Efficacy of neurocognitive function in surviving patients- HVLT-R Time Frame: 22 weeks	Comparison of HVLT-R results between groups at study end.	22 weeks
Efficacy of neurocognitive function in surviving patients- TMT A & B Time Frame: 22 weeks	Comparison of TMT A & B results between groups at study end.	22 weeks
Efficacy of neurocognitive function in surviving patients- COWA Time Frame: 22 weeks	Comparison of COWA results between groups at study end.	22 weeks
Efficacy of neurocognitive function in surviving patients- EORTCQLQ30/BN20 Time Frame: 22 weeks	Comparison of EORTCQLQ30/BN20 results between groups at study end.	22 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Michael D Chan, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 25, 2019

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

March 2, 2018

First Submitted That Met QC Criteria

March 21, 2018

First Posted (Actual)

March 23, 2018

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 20, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

IRB00053531
3UG1CA189824-04S1 (U.S. NIH Grant/Contract)
NCI-2018-01807 (Registry Identifier: NCI CTRP (Clinical Trial Reporting Program))
WF-1801 (Other Identifier: Wake Forest NCORP Research Base)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Wake Forest NCORP Research Base is committed to following the NIH Statement on Sharing Research Data (http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html). As of July 2018, the WF NCORP RB signed an agreement with NCI to contribute de-identified data and data dictionaries from clinical trials conducted through our RB to the NCI NCTN/NCORP data archive within 6 months of primary and non-primary publications of phase II/III and phase III trials to https://nctn-data-archive.nci.nih.gov/. This will become the primary means for sharing raw data, and we will adhere to the guidelines spelled out in the NCTN/NCORP Data Archive Usage Guide. De-identified data from studies not covered by the agreement (e.g., phase II and observational studies) will be made available upon request. All data files will be de-identified. De-identification procedures will meet the HIPAA criteria as detailed in the Code of Federal Regulations, Part 45, Section 164.514.

IPD Sharing Time Frame

6 months after publication for a 2 year duration

IPD Sharing Access Criteria

upon request to NCORP@wakehealth.edu

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Institut de Recherches Cliniques de Montreal

Terminated

Higher Dose of Ramipril Versus Addition of Telmisartan-Ramipril in Hypertension and Diabetes

Hypertension | Type 2 Diabetes | Albuminuria

Canada
Pfizer

Terminated

A Study of the Effectiveness and Safety of Ramipril in the Treatment of Hypertension in Children and Adolescents

Hypertension

United States, Argentina, Colombia, India, Chile, Poland, South Africa, Turkey, Ukraine

Testing Ramipril to Prevent Memory Loss in People With Glioblastoma

A Single Arm, Pilot Study of Ramipril for Preventing Radiation-Induced Cognitive Decline in Glioblastoma (GBM) Patients Receiving Brain Radiotherapy

Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Estimated)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

product manufactured in and exported from the U.S.

Clinical Trials on Glioblastoma

Clinical Trials on Ramipril

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations