AzTrials
AzTrials

FatiguePhase 3NCT01781468

Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma

A Phase 3 study testing armodafinil 150 mg and armodafinil 250 mg in people with Fatigue, run by Alliance for Clinical Trials in Oncology at 365 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This randomized phase III trial studies armodafinil to see how well it works in reducing cancer-related fatigue in patients with high grade glioma. Armodafinil may help relieve fatigue in patients with high grade glioma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Fatigue
What is being tested?
armodafinil 150 mg and armodafinil 250 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
328 participants
Where
365 sitesUnited States
Study dates
21 Jun 2013to 15 Dec 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosed with glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with oligo features, glioblastoma with primitive neuroectodermal tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma who are clinically stable and have completed radiation therapy (excluding stereotactic radiosurgery) > 21 days and =< 24 months prior to enrollment; NOTE: clinical stability will be defined as a stable or improved Karnofsky performance status (KPS) compared to the prior month
  • >= 6 score on the worst fatigue question of the BFI (Brief Fatigue Inventory, question 3); it is not required for the patient to complete the entire BFI to meet this criterion
  • Undergone surgery (gross total or subtotal resection) or biopsy and will have been treated with concurrent radiation therapy and chemotherapy as standard of care for glioblastoma, gliosarcoma, small cell or large cell glioblastoma, glioblastoma with oligo features, glioblastoma with primitive neuroectodermal tumor-like components (GBM-PNET) features, anaplastic astrocytoma, anaplastic oligodendroglioma, or anaplastic oligoastrocytoma patients; Note: radiation must be completed, but chemotherapy is allowed; patients who are currently using Optune device will be eligible to participate in this trial
  • Negative serum pregnancy test done =< 7 days prior to registration only for women determined to be of childbearing potential by their treating physician
  • Ability to complete questionnaire(s) by themselves or with assistance
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2 or 3
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  • Provide informed written consent
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study)
  • Stable dose of corticosteroid >= 14 days prior to registration

Who cannot join

None listed.

Trial locations and contacts

365 sites in 1 country.

300 sites in 1 country

United States300 sites

  • Hawaii Oncology Inc-Pali Momi

    ‘Aiea, Hawaii, 96701

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701

  • The Cancer Center of Hawaii-Pali Momi

    ‘Aiea, Hawaii, 96701

  • Avera Cancer Institute-Aberdeen

    Aberdeen, South Dakota, 57401

  • Providence Regional Cancer System-Aberdeen

    Aberdeen, Washington, 98520

  • Cleveland Clinic Akron General

    Akron, Ohio, 44307

  • Lehigh Valley Hospital-Cedar Crest

    Allentown, Pennsylvania, 18103

  • Mary Greeley Medical Center

    Ames, Iowa, 50010

  • McFarland Clinic PC - Ames

    Ames, Iowa, 50010

  • Alaska Breast Care and Surgery LLC

    Anchorage, Alaska, 99508

  • Alaska Women's Cancer Care

    Anchorage, Alaska, 99508

  • Anchorage Oncology Centre

    Anchorage, Alaska, 99508

  • Katmai Oncology Group

    Anchorage, Alaska, 99508

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • AnMed Health Cancer Center

    Anderson, South Carolina, 29621

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106

  • Mission Hospital Inc-Memorial Campus

    Asheville, North Carolina, 28801

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Northside Hospital

    Atlanta, Georgia, 30342

  • MultiCare Auburn Medical Center

    Auburn, Washington, 98001

  • Augusta University Medical Center

    Augusta, Georgia, 30912

  • Dell Seton Medical Center at The University of Texas

    Austin, Texas, 78701

  • Austin Cancer Centers-Central Austin

    Austin, Texas, 78702

  • Austin Cancer Centers-North

    Austin, Texas, 78758

  • The NeuroMedical Center-Clinic

    Baton Rouge, Louisiana, 70810

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • PeaceHealth Saint Joseph Medical Center

    Bellingham, Washington, 98225

  • Saint Charles Health System

    Bend, Oregon, 97701

  • Alta Bates Summit Medical Center-Herrick Campus

    Berkeley, California, 94704

  • Lehigh Valley Hospital - Muhlenberg

    Bethlehem, Pennsylvania, 18017

  • Billings Clinic Cancer Center

    Billings, Montana, 59101

  • Illinois CancerCare-Bloomington

    Bloomington, Illinois, 61704

  • Boca Raton Regional Hospital

    Boca Raton, Florida, 33486

  • Saint Alphonsus Cancer Care Center-Boise

    Boise, Idaho, 83706

  • Central Care Cancer Center - Bolivar

    Bolivar, Missouri, 65613

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Harrison HealthPartners Hematology and Oncology-Bremerton

    Bremerton, Washington, 98310

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Highline Medical Center-Main Campus

    Burien, Washington, 98166

  • Mills-Peninsula Medical Center

    Burlingame, California, 94010

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Illinois CancerCare-Canton

    Canton, Illinois, 61520

  • Caro Cancer Center

    Caro, Michigan, 48723

  • Illinois CancerCare-Carthage

    Carthage, Illinois, 62321

  • Mercy Hospital

    Cedar Rapids, Iowa, 52403

  • Oncology Associates at Mercy Medical Center

    Cedar Rapids, Iowa, 52403

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801

  • Providence Regional Cancer System-Centralia

    Centralia, Washington, 98531

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Carolinas Medical Center/Levine Cancer Institute

    Charlotte, North Carolina, 28203

  • Novant Health Presbyterian Medical Center

    Charlotte, North Carolina, 28204

  • Saint Luke's Hospital

    Chesterfield, Missouri, 63017

  • Northwestern University

    Chicago, Illinois, 60611

  • Clackamas Radiation Oncology Center

    Clackamas, Oregon, 97015

  • Southeastern Medical Oncology Center-Clinton

    Clinton, North Carolina, 28328

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • Community Cancer Institute

    Clovis, California, 93611

  • University Oncology Associates

    Clovis, California, 93611

  • Billings Clinic-Cody

    Cody, Wyoming, 82414

  • Kootenai Medical Center

    Coeur d'Alene, Idaho, 83814

  • Penrose-Saint Francis Healthcare

    Colorado Springs, Colorado, 80907

  • Rocky Mountain Cancer Centers-Penrose

    Colorado Springs, Colorado, 80907

  • University of Missouri - Ellis Fischel

    Columbia, Missouri, 65212

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • John Muir Medical Center-Concord Campus

    Concord, California, 94520

  • New Hampshire Oncology Hematology PA-Concord

    Concord, New Hampshire, 03301

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Baptist Health Corbin

    Corbin, Kentucky, 40701

  • Greater Regional Medical Center

    Creston, Iowa, 50801

  • Michiana Hematology Oncology PC-Crown Point

    Crown Point, Indiana, 46307

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Carle on Vermilion

    Danville, Illinois, 61832

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822

  • Florida Hospital Memorial Medical Center

    Daytona Beach, Florida, 32117

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Ascension Saint John Hospital

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Essentia Health Cancer Center

    Duluth, Minnesota, 55805

  • Greenville Health System Cancer Institute-Easley

    Easley, South Carolina, 29640

  • Hematology Oncology Associates of Central New York-East Syracuse

    East Syracuse, New York, 13057

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401

  • Crossroads Cancer Center

    Effingham, Illinois, 62401

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Elkhart Clinic

    Elkhart, Indiana, 46514-2098

  • Michiana Hematology Oncology PC-Elkhart

    Elkhart, Indiana, 46514

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Mercy Cancer Center-Elyria

    Elyria, Ohio, 44035

  • Illinois CancerCare-Eureka

    Eureka, Illinois, 61530

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Fairbanks Memorial Hospital

    Fairbanks, Alaska, 99701

  • Genesee Cancer and Blood Disease Treatment Center

    Flint, Michigan, 48503

  • Genesee Hematology Oncology PC

    Flint, Michigan, 48503

  • Genesys Hurley Cancer Institute

    Flint, Michigan, 48503

  • Hurley Medical Center

    Flint, Michigan, 48503

  • Aurora Health Center-Fond du Lac

    Fond du Lac, Wisconsin, 54937

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Gibbs Cancer Center-Gaffney

    Gaffney, South Carolina, 29341

  • Northeast Georgia Medical Center-Gainesville

    Gainesville, Georgia, 30501

  • Kaiser Permanente-Gaithersburg Medical Center

    Gaithersburg, Maryland, 20879

  • Illinois CancerCare-Galesburg

    Galesburg, Illinois, 61401

  • Adams Cancer Center

    Gettysburg, Pennsylvania, 17325

  • MultiCare Gig Harbor Medical Park

    Gig Harbor, Washington, 98335

  • NorthShore University HealthSystem-Glenbrook Hospital

    Glenview, Illinois, 60026

  • Southeastern Medical Oncology Center-Goldsboro

    Goldsboro, North Carolina, 27534

  • Wayne Memorial Hospital

    Goldsboro, North Carolina, 27534

  • Altru Cancer Center

    Grand Forks, North Dakota, 58201

  • CHI Health Saint Francis

    Grand Island, Nebraska, 68803

  • Cancer Research Consortium of West Michigan NCORP

    Grand Rapids, Michigan, 49503

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Benefis Healthcare- Sletten Cancer Institute

    Great Falls, Montana, 59405

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Saint Vincent Hospital Cancer Center Green Bay

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology Limited at Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Saint Vincent Hospital Cancer Center at Saint Mary's

    Green Bay, Wisconsin, 54303

  • Aurora BayCare Medical Center

    Green Bay, Wisconsin, 54311

  • Greenville Health System Cancer Institute-Andrews

    Greenville, South Carolina, 29601

  • Greenville Health System Cancer Institute-Butternut

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Faris

    Greenville, South Carolina, 29605

  • Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Eastside

    Greenville, South Carolina, 29615

  • Greenville Health System Cancer Institute-Greer

    Greer, South Carolina, 29650

  • Gibbs Cancer Center-Pelham

    Greer, South Carolina, 29651

  • Legacy Mount Hood Medical Center

    Gresham, Oregon, 97030

  • Cherry Tree Cancer Center

    Hanover, Pennsylvania, 17331

  • Cancer and Blood Specialists-Henderson

    Henderson, Nevada, 89052

  • Comprehensive Cancer Centers of Nevada - Henderson

    Henderson, Nevada, 89052

  • Las Vegas Cancer Center-Henderson

    Henderson, Nevada, 89052

  • OptumCare Cancer Care at Seven Hills

    Henderson, Nevada, 89052

  • 21st Century Oncology-Henderson

    Henderson, Nevada, 89074

  • Comprehensive Cancer Centers of Nevada-Southeast Henderson

    Henderson, Nevada, 89074

  • AdventHealth Hendersonville

    Hendersonville, North Carolina, 28792

  • NorthShore University HealthSystem-Highland Park Hospital

    Highland Park, Illinois, 60035

  • Hawaii Cancer Care Inc-POB II

    Honolulu, Hawaii, 96813

  • Queen's Medical Center

    Honolulu, Hawaii, 96813

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Hawaii Cancer Care Inc-Liliha

    Honolulu, Hawaii, 96817

  • Hawaii Oncology Inc-Kuakini

    Honolulu, Hawaii, 96817

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817

  • New Hampshire Oncology Hematology PA-Hooksett

    Hooksett, New Hampshire, 03106

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Southeastern Medical Oncology Center-Jacksonville

    Jacksonville, North Carolina, 28546

  • Freeman Health System

    Joplin, Missouri, 64804

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • CHI Health Good Samaritan

    Kearney, Nebraska, 68847

  • Novant Health Oncology Specialists-Kernersville

    Kernersville, North Carolina, 27284

  • Illinois CancerCare-Kewanee Clinic

    Kewanee, Illinois, 61443

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Regional Cancer Center at Indian Path Community Hospital

    Kingsport, Tennessee, 37660

  • Vidant Oncology-Kinston

    Kinston, North Carolina, 28501

  • Thompson Cancer Survival Center

    Knoxville, Tennessee, 37916

  • Thompson Cancer Survival Center - West

    Knoxville, Tennessee, 37932

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • UC San Diego Moores Cancer Center

    La Jolla, California, 92093

  • IU Health La Porte Hospital

    La Porte, Indiana, 46350

  • Providence Regional Cancer System-Lacey

    Lacey, Washington, 98503

  • LRGHealthcare-Lakes Region General Hospital

    Laconia, New Hampshire, 03246

  • Lakeland Regional Health Hollis Cancer Center

    Lakeland, Florida, 33805

  • Kaiser Permanente - Largo Medical Center

    Largo, Maryland, 20774

  • Cancer and Blood Specialists-Shadow

    Las Vegas, Nevada, 89106

  • Radiation Oncology Centers of Nevada Central

    Las Vegas, Nevada, 89106

  • 21st Century Oncology

    Las Vegas, Nevada, 89109

  • HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

    Las Vegas, Nevada, 89109

  • HealthCare Partners Medical Group Oncology/Hematology-San Martin

    Las Vegas, Nevada, 89113

  • Radiation Oncology Centers of Nevada Southeast

    Las Vegas, Nevada, 89119

  • Cancer Therapy and Integrative Medicine

    Las Vegas, Nevada, 89121

  • 21st Century Oncology-Vegas Tenaya

    Las Vegas, Nevada, 89128

  • Ann M Wierman MD LTD

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada - Northwest

    Las Vegas, Nevada, 89128

  • HealthCare Partners Medical Group Oncology/Hematology-Tenaya

    Las Vegas, Nevada, 89128

  • Comprehensive Cancer Centers of Nevada-Summerlin

    Las Vegas, Nevada, 89144

  • Las Vegas Cancer Center-Medical Center

    Las Vegas, Nevada, 89148-2405

  • 21st Century Oncology-Fort Apache

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89148

  • OptumCare Cancer Care at Fort Apache

    Las Vegas, Nevada, 89148

  • Comprehensive Cancer Centers of Nevada - Central Valley

    Las Vegas, Nevada, 89169

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Thompson Oncology Group-Lenoir City

    Lenoir City, Tennessee, 37772

  • Central Maine Medical Center

    Lewiston, Maine, 04240

  • Baptist Health Lexington

    Lexington, Kentucky, 40503

  • University of Kentucky/Markey Cancer Center

    Lexington, Kentucky, 40536

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • Nebraska Cancer Research Center

    Lincoln, Nebraska, 68510

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • PeaceHealth Saint John Medical Center

    Longview, Washington, 98632

  • Baptist Health Louisville

    Louisville, Kentucky, 40207

  • Illinois CancerCare-Macomb

    Macomb, Illinois, 61455

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Baptist Health Madisonville/Merle Mahr Cancer Center

    Madisonville, Kentucky, 42431

  • Cancer Center of Kansas-Manhattan

    Manhattan, Kansas, 66502

  • Holy Family Memorial Hospital

    Manitowoc, Wisconsin, 54221

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Saint Mary's Oncology/Hematology Associates of Marlette

    Marlette, Michigan, 48453

  • UP Health System Hematology Oncology Marquette

    Marquette, Michigan, 49855

  • UP Health System Marquette

    Marquette, Michigan, 49855

  • Culicchia Neurological Clinic LLC

    Marrero, Louisiana, 70072

  • West Jefferson Medical Center

    Marrero, Louisiana, 70072

  • Marshfield Medical Center-Marshfield

    Marshfield, Wisconsin, 54449

  • Mercy Medical Center - North Iowa

    Mason City, Iowa, 50401

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938

  • Toledo Clinic Cancer Centers-Maumee

    Maumee, Ohio, 43537

  • Kaiser Permanente Tysons Corner Medical Center

    McLean, Virginia, 22102

  • Cancer Center of Kansas - McPherson

    McPherson, Kansas, 67460

  • University of Miami Miller School of Medicine-Sylvester Cancer Center

    Miami, Florida, 33136

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Froedtert and the Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Health Partners Inc

    Minneapolis, Minnesota, 55454

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin, 54548

  • Memorial Regional Cancer Center Day Road

    Mishawaka, Indiana, 46545

  • Michiana Hematology Oncology PC-Mishawaka

    Mishawaka, Indiana, 46545

  • Saint Joseph Regional Medical Center-Mishawaka

    Mishawaka, Indiana, 46545

  • Saint Patrick Hospital - Community Hospital

    Missoula, Montana, 59802

  • Memorial Medical Center

    Modesto, California, 95355

  • Trinity Medical Center

    Moline, Illinois, 61265

  • Monticello Cancer Center

    Monticello, Minnesota, 55362

  • West Virginia University Healthcare

    Morgantown, West Virginia, 26506

  • Novant Health Oncology Specialists-Mount Airy

    Mount Airy, North Carolina, 27030

  • Good Samaritan Regional Health Center

    Mount Vernon, Illinois, 62864

  • ProHealth D N Greenwald Center

    Mukwonago, Wisconsin, 53149

  • Louisiana State University Health Science Center

    New Orleans, Louisiana, 70112

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Helen F Graham Cancer Center

    Newark, Delaware, 19713

  • Medical Oncology Hematology Consultants PA

    Newark, Delaware, 19713

  • Regional Hematology and Oncology PA

    Newark, Delaware, 19713

  • Christiana Care Health System-Christiana Hospital

    Newark, Delaware, 19718

  • Providence Newberg Medical Center

    Newberg, Oregon, 97132

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Southwest VA Regional Cancer Center

    Norton, Virginia, 24273

  • Thompson Oncology Group-Oak Ridge

    Oak Ridge, Tennessee, 37830

  • ProHealth Oconomowoc Memorial Hospital

    Oconomowoc, Wisconsin, 53066

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Alegent Health Bergan Mercy Medical Center

    Omaha, Nebraska, 68124

  • Alegent Health Lakeside Hospital

    Omaha, Nebraska, 68130

  • Creighton University Medical Center

    Omaha, Nebraska, 68131

  • Saint Joseph Hospital - Orange

    Orange, California, 92868

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868

  • Saint Charles Hospital

    Oregon, Ohio, 43616

  • Providence Willamette Falls Medical Center

    Oregon City, Oregon, 97045

  • Florida Hospital Orlando

    Orlando, Florida, 32803

  • Vince Lombardi Cancer Clinic - Oshkosh

    Oshkosh, Wisconsin, 54904

  • Illinois CancerCare-Ottawa Clinic

    Ottawa, Illinois, 61350

  • Baptist Health Paducah

    Paducah, Kentucky, 42003

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Illinois CancerCare-Pekin

    Pekin, Illinois, 61554

  • Sacred Heart Hospital

    Pensacola, Florida, 32504

  • Illinois CancerCare-Peoria

    Peoria, Illinois, 61615

  • Methodist Medical Center of Illinois

    Peoria, Illinois, 61636

  • OSF Saint Francis Medical Center

    Peoria, Illinois, 61637

  • Mercy Health Perrysburg Cancer Center

    Perrysburg, Ohio, 43551

  • Illinois CancerCare-Peru

    Peru, Illinois, 61354

  • Saint Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Arizona Oncology-Deer Valley Center

    Phoenix, Arizona, 85027

  • Michiana Hematology Oncology PC-Plymouth

    Plymouth, Indiana, 46563

  • Jefferson Healthcare

    Port Townsend, Washington, 98368

  • Legacy Good Samaritan Hospital and Medical Center

    Portland, Oregon, 97210

  • Providence Portland Medical Center

    Portland, Oregon, 97213

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225

  • Kaiser Permanente Northwest

    Portland, Oregon, 97227

  • Kootenai Cancer Center

    Post Falls, Idaho, 83854

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Illinois CancerCare-Princeton

    Princeton, Illinois, 61356

  • MultiCare Good Samaritan Hospital

    Puyallup, Washington, 98372

  • Rapid City Regional Hospital

    Rapid City, South Dakota, 57701

  • Marshfield Medical Center-Rice Lake

    Rice Lake, Wisconsin, 54868

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Highland Hospital

    Rochester, New York, 14620

  • University Radiation Oncology

    Rochester, New York, 14626

  • University of Rochester

    Rochester, New York, 14642

  • Unspecified Site

    Rockville, Maryland, 20852

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Michigan, 48073

  • Ascension Saint Mary's Hospital

    Saginaw, Michigan, 48601

  • Oncology Hematology Associates of Saginaw Valley PC

    Saginaw, Michigan, 48604

  • Lakeland Medical Center Saint Joseph

    Saint Joseph, Michigan, 49085

  • Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64507

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • University of Texas Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • Kootenai Cancer Clinic

    Sandpoint, Idaho, 83864

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051

  • Mayo Clinic in Arizona

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: A Phase III Randomized, Double-Blind Placebo Controlled Study of Armodafinil (Nuvigil®) To Reduce Cancer-Related Fatigue in Patients With High Grade Glioma

This randomized phase III trial studies armodafinil to see how well it works in reducing cancer-related fatigue in patients with high grade glioma. Armodafinil may help relieve fatigue in patients with high grade glioma.

Read the detailed description

Patients experiencing fatigue related to cancer will be asked to take part in this study. Cancer-related fatigue is a very common symptom in patients with cancer. Patients will receive armodafinil or placebo. Please see the "Arms" section for more details regarding the treatment assignments. The primary objective of this study is to determine preliminary efficacy measured by patient reported fatigue Brief Fatigue Inventory (BFI) at 8 weeks of two doses (150 mg and 250 mg) of armodafinil in treating moderate fatigue compared to placebo in patients with high grade glioma.

The secondary objectives of the study are listed below.

  1. To evaluate the tolerability at 8 weeks of 150 mg and 250 mg armodafinil in this patient population.
  2. To assess the effect of armodafinil at 8 weeks on cognitive function in patients with high grade glioma.
  3. To assess the impact of armodafinil on global quality of life and other fatigue endpoints in this patient population with high grade glioma.
  4. Explore the correlation between the BFI, Patient-Reported Outcomes Measurement Information System (PROMIS), and Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) measures, as well as, the relationship of fatigue and cognitive difficulties.

Patients will receive armodafinil or placebo for a total of 8 weeks.

Conditions
Fatigue
Being tested
armodafinil 150 mg, Placebo, armodafinil 250 mg
Medical subject headings
Fatigue

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • armodafinil 150 mgDrug

    given orally

  • PlaceboOther

    given orally

  • armodafinil 250 mgDrug

    given orally

Study groups in NCT01781468
Study groupRoleWhat they receive
Arm IExperimentalPatients receive 150 mg armodafinil orally every day in the morning for 8 weeks.
Receives: Drug: armodafinil 150 mg
Arm IIPlacebo comparatorPatients receive placebo orally every day in the morning for 8 weeks.
Receives: Other: Placebo
Arm IIIExperimentalPatients receive 250 mg armodafinil orally every day in the morning for 8 weeks.
Receives: Drug: armodafinil 250 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Number of Participants With a Response in Terms of a Clinically Meaningful Improvement in Patient-reported Fatigue at 8 Weeks.

    A response is defined as an improvement of 2 points on the 0-10 scale of the usual fatigue on the Brief Fatigue Inventory (BFI). The number of participants with a response in terms of a clinically meaningful improvement in patient-reported fatigue at 8 weeks.

    Scale: 0 (No fatigue) - 10 (As bad as you can imagine) Interpretation: higher scores mean a worse outcome

    Measured: At 8 weeks

Secondary outcomes (4)

  1. Fatigue: Brief Fatigue Inventory (BFI): The Number of Participants With a Response in Terms of a Clinically Meaningful Improvement in Patient-reported Fatigue at 4 Weeks.

    A response is defined as an improvement of 2 points on the 0-10 scale of the usual fatigue on the Brief Fatigue Inventory (BFI). The number of participants with a response in terms of a clinically meaningful improvement in patient-reported fatigue at 4 weeks Scale: 0 (No fatigue) - 10 (As bad as you can imagine) Interpretation: higher scores mean a worse outcome

    Measured: Up to 4 weeks

  2. Cognitive Function: Assessed by the Change in Z Score for Symbol Digit Modalities Test (SDMT) From Baseline to End of Week 8

    The participant is presented with a page headed by a key that pairs the single digits 1-9 with nine symbols. Rows below contain only symbols, the subject's task is to orally report the correct number in the spaces below. After completing the first 10 items with guidance, the subject is timed to determine how many responses can be made in 90 seconds. Range score: not applicable. Higher scores mean a better outcome. Explored domain: Sustained attention and information processing speed. Each neuropsychological measure was converted to an age-normative z score using published normative data. Impaired SDMT performance was defined as falling one standard deviation or more below the normative mean.

    Measured: Up to 8 weeks

  3. Change in Quality of Life as Measured by Linear Analogue Self Assessment (LASA) From Baseline to End of Weeks 4 and 8

    Quality of life: Linear Analogue Self Assessment (LASA) will be analyzed comparing the total score for each treatment testing for change from baseline to four and eight weeks. Linear Analogue Self Assessment (LASA) is a 12 global QOL tool to which measures 10 subscales: overall QOL, physical well-being, fatigue, frequency and severity of pain, as well as social functioning and spiritual, emotional and mental well-being. All subscales were converted to a scale of 0-100, with higher scores indicating better QOL. Total score is the average of all 10 subscales.

    Measured: Up to 8 weeks

  4. Number of Participants Who Experienced at Least One Grade 3 or Higher Adverse Events Deemed at Least Possibly Related to Treatment Via the CTCAE Version 4.0

    The number of participants who experienced at least one grade 3 or higher adverse events deemed at least possibly related to treatment via the CTCAE version 4.0

    Measured: Up to 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2013 (estimated)
  2. Study start21 Jun 2013
  3. Primary completionMay 2019
  4. Study completion15 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
328 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01781468
Sponsor's protocol ID
A221101
Other IDs
N10C3, NCI-2012-02020, U10CA037404, U10CA037447, UG1CA189823
Status last verified
Jan 2025
First submitted
29 Jan 2013
Last updated
27 Jan 2025
Data monitoring committee
Yes
Individual data sharing
Yes: IPD that underlie results in the publication PubMed ID 34882169.

Publications

  • Porter AB, Liu H, Kohli S, Cerhan JL, Sloan J, McMurray RP, Le-Rademacher J, Loprinzi CL, Villano JL, Kizilbash SH, Mehta MP, Jaeckle KA, Brown PD. Efficacy of Treatment With Armodafinil for Cancer-Related Fatigue in Patients With High-grade Glioma: A Phase 3 Randomized Clinical Trial. JAMA Oncol. 2022 Feb 1;8(2):259-267. doi: 10.1001/jamaoncol.2021.5948.

    PubMed 34882169

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing armodafinil 150 mg and armodafinil 250 mg in people with Fatigue, run by Alliance for Clinical Trials in Oncology at 365 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 365 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Number of Participants With a Response in Terms of a Clinically Meaningful Improvement in Patient-reported Fatigue at 8 Weeks. (time frame: At 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01781468, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2025.

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