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

NCT ID: NCT01781468

Last Updated: 2025-01-27

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

328 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-21

Study Completion Date

2019-12-15

Brief Summary

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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.

Detailed Description

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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

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Fatigue

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm I

Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks.

Group Type EXPERIMENTAL

armodafinil 150 mg

Intervention Type DRUG

given orally

Arm II

Patients receive placebo orally every day in the morning for 8 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

given orally

Arm III

Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks.

Group Type EXPERIMENTAL

armodafinil 250 mg

Intervention Type DRUG

given orally

Interventions

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armodafinil 150 mg

given orally

Intervention Type DRUG

Placebo

given orally

Intervention Type OTHER

armodafinil 250 mg

given orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Alliance for Clinical Trials in Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alyx B. Porter Umphrey, MD

Role: STUDY_CHAIR

Mayo Clinic

Locations

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Alaska Breast Care and Surgery LLC

Anchorage, Alaska, United States

Site Status

Alaska Women's Cancer Care

Anchorage, Alaska, United States

Site Status

Anchorage Oncology Centre

Anchorage, Alaska, United States

Site Status

Katmai Oncology Group

Anchorage, Alaska, United States

Site Status

Providence Alaska Medical Center

Anchorage, Alaska, United States

Site Status

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

Site Status

Saint Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Site Status

Arizona Oncology-Deer Valley Center

Phoenix, Arizona, United States

Site Status

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status

Arizona Oncology Services Foundation

Scottsdale, Arizona, United States

Site Status

Alta Bates Summit Medical Center-Herrick Campus

Berkeley, California, United States

Site Status

Providence Saint Joseph Medical Center/Disney Family Cancer Center

Burbank, California, United States

Site Status

Mills-Peninsula Medical Center

Burlingame, California, United States

Site Status

Community Cancer Institute

Clovis, California, United States

Site Status

University Oncology Associates

Clovis, California, United States

Site Status

John Muir Medical Center-Concord Campus

Concord, California, United States

Site Status

UC San Diego Moores Cancer Center

La Jolla, California, United States

Site Status

Loma Linda University Medical Center

Loma Linda, California, United States

Site Status

Memorial Medical Center

Modesto, California, United States

Site Status

Saint Joseph Hospital - Orange

Orange, California, United States

Site Status

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, United States

Site Status

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, United States

Site Status

Kaiser Permanente-Vallejo

Vallejo, California, United States

Site Status

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Site Status

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Site Status

SCL Health Lutheran Medical Center

Wheat Ridge, Colorado, United States

Site Status

Helen F Graham Cancer Center

Newark, Delaware, United States

Site Status

Medical Oncology Hematology Consultants PA

Newark, Delaware, United States

Site Status

Regional Hematology and Oncology PA

Newark, Delaware, United States

Site Status

Christiana Care Health System-Christiana Hospital

Newark, Delaware, United States

Site Status

Kaiser Permanente-Capitol Hill Medical Center

Washington D.C., District of Columbia, United States

Site Status

Boca Raton Regional Hospital

Boca Raton, Florida, United States

Site Status

Florida Hospital Memorial Medical Center

Daytona Beach, Florida, United States

Site Status

Lakeland Regional Health Hollis Cancer Center

Lakeland, Florida, United States

Site Status

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Site Status

Florida Hospital Orlando

Orlando, Florida, United States

Site Status

Sacred Heart Hospital

Pensacola, Florida, United States

Site Status

Piedmont Hospital

Atlanta, Georgia, United States

Site Status

Northside Hospital

Atlanta, Georgia, United States

Site Status

Augusta University Medical Center

Augusta, Georgia, United States

Site Status

Northeast Georgia Medical Center-Gainesville

Gainesville, Georgia, United States

Site Status

Hawaii Cancer Care Inc-POB II

Honolulu, Hawaii, United States

Site Status

Queen's Medical Center

Honolulu, Hawaii, United States

Site Status

Straub Clinic and Hospital

Honolulu, Hawaii, United States

Site Status

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Site Status

Hawaii Cancer Care Inc-Liliha

Honolulu, Hawaii, United States

Site Status

Hawaii Oncology Inc-Kuakini

Honolulu, Hawaii, United States

Site Status

The Cancer Center of Hawaii-Liliha

Honolulu, Hawaii, United States

Site Status

Hawaii Oncology Inc-Pali Momi

‘Aiea, Hawaii, United States

Site Status

Pali Momi Medical Center

‘Aiea, Hawaii, United States

Site Status

The Cancer Center of Hawaii-Pali Momi

‘Aiea, Hawaii, United States

Site Status

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Site Status

Kootenai Medical Center

Coeur d'Alene, Idaho, United States

Site Status

Kootenai Cancer Center

Post Falls, Idaho, United States

Site Status

Kootenai Cancer Clinic

Sandpoint, Idaho, United States

Site Status

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Site Status

Illinois CancerCare-Canton

Canton, Illinois, United States

Site Status

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Site Status

Centralia Oncology Clinic

Centralia, Illinois, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Carle on Vermilion

Danville, Illinois, United States

Site Status

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Site Status

Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status

Carle Physician Group-Effingham

Effingham, Illinois, United States

Site Status

Crossroads Cancer Center

Effingham, Illinois, United States

Site Status

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Site Status

NorthShore University HealthSystem-Evanston Hospital

Evanston, Illinois, United States

Site Status

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Site Status

NorthShore University HealthSystem-Glenbrook Hospital

Glenview, Illinois, United States

Site Status

NorthShore University HealthSystem-Highland Park Hospital

Highland Park, Illinois, United States

Site Status

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Site Status

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Site Status

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

Site Status

Trinity Medical Center

Moline, Illinois, United States

Site Status

Good Samaritan Regional Health Center

Mount Vernon, Illinois, United States

Site Status

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Site Status

Illinois CancerCare-Pekin

Pekin, Illinois, United States

Site Status

Illinois CancerCare-Peoria

Peoria, Illinois, United States

Site Status

Methodist Medical Center of Illinois

Peoria, Illinois, United States

Site Status

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Site Status

Illinois CancerCare-Peru

Peru, Illinois, United States

Site Status

Illinois CancerCare-Princeton

Princeton, Illinois, United States

Site Status

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Site Status

Springfield Clinic

Springfield, Illinois, United States

Site Status

Memorial Medical Center

Springfield, Illinois, United States

Site Status

Carle Cancer Center

Urbana, Illinois, United States

Site Status

The Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States

Site Status

Michiana Hematology Oncology PC-Crown Point

Crown Point, Indiana, United States

Site Status

Elkhart Clinic

Elkhart, Indiana, United States

Site Status

Michiana Hematology Oncology PC-Elkhart

Elkhart, Indiana, United States

Site Status

Elkhart General Hospital

Elkhart, Indiana, United States

Site Status

Community Howard Regional Health

Kokomo, Indiana, United States

Site Status

IU Health La Porte Hospital

La Porte, Indiana, United States

Site Status

Memorial Regional Cancer Center Day Road

Mishawaka, Indiana, United States

Site Status

Michiana Hematology Oncology PC-Mishawaka

Mishawaka, Indiana, United States

Site Status

Saint Joseph Regional Medical Center-Mishawaka

Mishawaka, Indiana, United States

Site Status

Michiana Hematology Oncology PC-Plymouth

Plymouth, Indiana, United States

Site Status

Memorial Hospital of South Bend

South Bend, Indiana, United States

Site Status

Michiana Hematology Oncology PC-South Bend

South Bend, Indiana, United States

Site Status

Michiana Hematology Oncology PC-Westville

Westville, Indiana, United States

Site Status

Mary Greeley Medical Center

Ames, Iowa, United States

Site Status

McFarland Clinic PC - Ames

Ames, Iowa, United States

Site Status

Mercy Hospital

Cedar Rapids, Iowa, United States

Site Status

Oncology Associates at Mercy Medical Center

Cedar Rapids, Iowa, United States

Site Status

Medical Oncology and Hematology Associates-West Des Moines

Clive, Iowa, United States

Site Status

Mercy Cancer Center-West Lakes

Clive, Iowa, United States

Site Status

Greater Regional Medical Center

Creston, Iowa, United States

Site Status

Medical Oncology and Hematology Associates-Laurel

Des Moines, Iowa, United States

Site Status

Mercy Medical Center - Des Moines

Des Moines, Iowa, United States

Site Status

Mercy Medical Center - North Iowa

Mason City, Iowa, United States

Site Status

Siouxland Regional Cancer Center

Sioux City, Iowa, United States

Site Status

Mercy Medical Center-West Lakes

West Des Moines, Iowa, United States

Site Status

Cancer Center of Kansas - Chanute

Chanute, Kansas, United States

Site Status

Cancer Center of Kansas - Dodge City

Dodge City, Kansas, United States

Site Status

Cancer Center of Kansas - El Dorado

El Dorado, Kansas, United States

Site Status

Cancer Center of Kansas - Fort Scott

Fort Scott, Kansas, United States

Site Status

Cancer Center of Kansas-Independence

Independence, Kansas, United States

Site Status

Cancer Center of Kansas-Kingman

Kingman, Kansas, United States

Site Status

Lawrence Memorial Hospital

Lawrence, Kansas, United States

Site Status

Cancer Center of Kansas-Liberal

Liberal, Kansas, United States

Site Status

Cancer Center of Kansas-Manhattan

Manhattan, Kansas, United States

Site Status

Cancer Center of Kansas - McPherson

McPherson, Kansas, United States

Site Status

Cancer Center of Kansas - Newton

Newton, Kansas, United States

Site Status

Cancer Center of Kansas - Parsons

Parsons, Kansas, United States

Site Status

Cancer Center of Kansas - Pratt

Pratt, Kansas, United States

Site Status

Cancer Center of Kansas - Salina

Salina, Kansas, United States

Site Status

Cotton O'Neil Cancer Center / Stormont Vail Health

Topeka, Kansas, United States

Site Status

Cancer Center of Kansas - Wellington

Wellington, Kansas, United States

Site Status

Associates In Womens Health

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas-Wichita Medical Arts Tower

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas - Wichita

Wichita, Kansas, United States

Site Status

Via Christi Regional Medical Center

Wichita, Kansas, United States

Site Status

Cancer Center of Kansas - Winfield

Winfield, Kansas, United States

Site Status

Baptist Health Corbin

Corbin, Kentucky, United States

Site Status

Baptist Health Lexington

Lexington, Kentucky, United States

Site Status

University of Kentucky/Markey Cancer Center

Lexington, Kentucky, United States

Site Status

Baptist Health Louisville

Louisville, Kentucky, United States

Site Status

Baptist Health Madisonville/Merle Mahr Cancer Center

Madisonville, Kentucky, United States

Site Status

Baptist Health Paducah

Paducah, Kentucky, United States

Site Status

The NeuroMedical Center-Clinic

Baton Rouge, Louisiana, United States

Site Status

Culicchia Neurological Clinic LLC

Marrero, Louisiana, United States

Site Status

West Jefferson Medical Center

Marrero, Louisiana, United States

Site Status

Louisiana State University Health Science Center

New Orleans, Louisiana, United States

Site Status

Central Maine Medical Center

Lewiston, Maine, United States

Site Status

Kaiser Permanente-Gaithersburg Medical Center

Gaithersburg, Maryland, United States

Site Status

Kaiser Permanente - Largo Medical Center

Largo, Maryland, United States

Site Status

Unspecified Site

Rockville, Maryland, United States

Site Status

Tufts Medical Center

Boston, Massachusetts, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Saint Joseph Mercy Hospital

Ann Arbor, Michigan, United States

Site Status

Bronson Battle Creek

Battle Creek, Michigan, United States

Site Status

Caro Cancer Center

Caro, Michigan, United States

Site Status

Ascension Saint John Hospital

Detroit, Michigan, United States

Site Status

Genesee Cancer and Blood Disease Treatment Center

Flint, Michigan, United States

Site Status

Genesee Hematology Oncology PC

Flint, Michigan, United States

Site Status

Genesys Hurley Cancer Institute

Flint, Michigan, United States

Site Status

Hurley Medical Center

Flint, Michigan, United States

Site Status

Cancer Research Consortium of West Michigan NCORP

Grand Rapids, Michigan, United States

Site Status

Mercy Health Saint Mary's

Grand Rapids, Michigan, United States

Site Status

Spectrum Health at Butterworth Campus

Grand Rapids, Michigan, United States

Site Status

West Michigan Cancer Center

Kalamazoo, Michigan, United States

Site Status

Saint Mary's Oncology/Hematology Associates of Marlette

Marlette, Michigan, United States

Site Status

UP Health System Hematology Oncology Marquette

Marquette, Michigan, United States

Site Status

UP Health System Marquette

Marquette, Michigan, United States

Site Status

William Beaumont Hospital-Royal Oak

Royal Oak, Michigan, United States

Site Status

Ascension Saint Mary's Hospital

Saginaw, Michigan, United States

Site Status

Oncology Hematology Associates of Saginaw Valley PC

Saginaw, Michigan, United States

Site Status

Lakeland Medical Center Saint Joseph

Saint Joseph, Michigan, United States

Site Status

Marie Yeager Cancer Center

Saint Joseph, Michigan, United States

Site Status

Ascension Providence Hospitals - Southfield

Southfield, Michigan, United States

Site Status

William Beaumont Hospital - Troy

Troy, Michigan, United States

Site Status

Saint John Macomb-Oakland Hospital

Warren, Michigan, United States

Site Status

Saint Mary's Oncology/Hematology Associates of West Branch

West Branch, Michigan, United States

Site Status

Metro Health Hospital

Wyoming, Michigan, United States

Site Status

Fairview Ridges Hospital

Burnsville, Minnesota, United States

Site Status

Mercy Hospital

Coon Rapids, Minnesota, United States

Site Status

Essentia Health Cancer Center

Duluth, Minnesota, United States

Site Status

Fairview-Southdale Hospital

Edina, Minnesota, United States

Site Status

Unity Hospital

Fridley, Minnesota, United States

Site Status

Minnesota Oncology Hematology PA-Maplewood

Maplewood, Minnesota, United States

Site Status

Saint John's Hospital - Healtheast

Maplewood, Minnesota, United States

Site Status

Abbott-Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status

Health Partners Inc

Minneapolis, Minnesota, United States

Site Status

Monticello Cancer Center

Monticello, Minnesota, United States

Site Status

North Memorial Medical Health Center

Robbinsdale, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

Park Nicollet Clinic - Saint Louis Park

Saint Louis Park, Minnesota, United States

Site Status

Regions Hospital

Saint Paul, Minnesota, United States

Site Status

United Hospital

Saint Paul, Minnesota, United States

Site Status

Minnesota Oncology Hematology PA-Woodbury

Woodbury, Minnesota, United States

Site Status

Central Care Cancer Center - Bolivar

Bolivar, Missouri, United States

Site Status

Saint Luke's Hospital

Chesterfield, Missouri, United States

Site Status

University of Missouri - Ellis Fischel

Columbia, Missouri, United States

Site Status

Freeman Health System

Joplin, Missouri, United States

Site Status

Saint Luke's Hospital of Kansas City

Kansas City, Missouri, United States

Site Status

Heartland Regional Medical Center

Saint Joseph, Missouri, United States

Site Status

Mercy Hospital Springfield

Springfield, Missouri, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Mercy Hospital Saint Louis

St Louis, Missouri, United States

Site Status

Billings Clinic Cancer Center

Billings, Montana, United States

Site Status

Benefis Healthcare- Sletten Cancer Institute

Great Falls, Montana, United States

Site Status

Saint Patrick Hospital - Community Hospital

Missoula, Montana, United States

Site Status

CHI Health Saint Francis

Grand Island, Nebraska, United States

Site Status

CHI Health Good Samaritan

Kearney, Nebraska, United States

Site Status

Nebraska Cancer Research Center

Lincoln, Nebraska, United States

Site Status

Alegent Health Bergan Mercy Medical Center

Omaha, Nebraska, United States

Site Status

Alegent Health Lakeside Hospital

Omaha, Nebraska, United States

Site Status

Creighton University Medical Center

Omaha, Nebraska, United States

Site Status

Cancer and Blood Specialists-Henderson

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Henderson

Henderson, Nevada, United States

Site Status

Las Vegas Cancer Center-Henderson

Henderson, Nevada, United States

Site Status

OptumCare Cancer Care at Seven Hills

Henderson, Nevada, United States

Site Status

21st Century Oncology-Henderson

Henderson, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada-Southeast Henderson

Henderson, Nevada, United States

Site Status

Cancer and Blood Specialists-Shadow

Las Vegas, Nevada, United States

Site Status

Radiation Oncology Centers of Nevada Central

Las Vegas, Nevada, United States

Site Status

21st Century Oncology

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-San Martin

Las Vegas, Nevada, United States

Site Status

Radiation Oncology Centers of Nevada Southeast

Las Vegas, Nevada, United States

Site Status

Cancer Therapy and Integrative Medicine

Las Vegas, Nevada, United States

Site Status

21st Century Oncology-Vegas Tenaya

Las Vegas, Nevada, United States

Site Status

Ann M Wierman MD LTD

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Northwest

Las Vegas, Nevada, United States

Site Status

HealthCare Partners Medical Group Oncology/Hematology-Tenaya

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada-Summerlin

Las Vegas, Nevada, United States

Site Status

Las Vegas Cancer Center-Medical Center

Las Vegas, Nevada, United States

Site Status

21st Century Oncology-Fort Apache

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

Site Status

OptumCare Cancer Care at Fort Apache

Las Vegas, Nevada, United States

Site Status

Comprehensive Cancer Centers of Nevada - Central Valley

Las Vegas, Nevada, United States

Site Status

New Hampshire Oncology Hematology PA-Concord

Concord, New Hampshire, United States

Site Status

New Hampshire Oncology Hematology PA-Hooksett

Hooksett, New Hampshire, United States

Site Status

LRGHealthcare-Lakes Region General Hospital

Laconia, New Hampshire, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Robert Wood Johnson University Hospital Somerset

Somerville, New Jersey, United States

Site Status

Hematology Oncology Associates of Central New York-East Syracuse

East Syracuse, New York, United States

Site Status

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

New York, New York, United States

Site Status

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status

Highland Hospital

Rochester, New York, United States

Site Status

University Radiation Oncology

Rochester, New York, United States

Site Status

University of Rochester

Rochester, New York, United States

Site Status

Montefiore Medical Center-Einstein Campus

The Bronx, New York, United States

Site Status

Montefiore Medical Center - Moses Campus

The Bronx, New York, United States

Site Status

Mission Hospital Inc-Memorial Campus

Asheville, North Carolina, United States

Site Status

Carolinas Medical Center/Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status

Novant Health Presbyterian Medical Center

Charlotte, North Carolina, United States

Site Status

Southeastern Medical Oncology Center-Clinton

Clinton, North Carolina, United States

Site Status

Southeastern Medical Oncology Center-Goldsboro

Goldsboro, North Carolina, United States

Site Status

Wayne Memorial Hospital

Goldsboro, North Carolina, United States

Site Status

AdventHealth Hendersonville

Hendersonville, North Carolina, United States

Site Status

Southeastern Medical Oncology Center-Jacksonville

Jacksonville, North Carolina, United States

Site Status

Novant Health Oncology Specialists-Kernersville

Kernersville, North Carolina, United States

Site Status

Vidant Oncology-Kinston

Kinston, North Carolina, United States

Site Status

Novant Health Oncology Specialists-Mount Airy

Mount Airy, North Carolina, United States

Site Status

Novant Health Oncology Specialists-Statesville

Statesville, North Carolina, United States

Site Status

Novant Health Oncology Specialists-Davidson County

Thomasville, North Carolina, United States

Site Status

Novant Health Oncology Specialists-Wilkesboro

Wilkesboro, North Carolina, United States

Site Status

Southeastern Medical Oncology Center-Wilson

Wilson, North Carolina, United States

Site Status

Novant Health Forsyth Medical Center

Winston-Salem, North Carolina, United States

Site Status

Novant Health Oncology Specialists

Winston-Salem, North Carolina, United States

Site Status

Altru Cancer Center

Grand Forks, North Dakota, United States

Site Status

Cleveland Clinic Akron General

Akron, Ohio, United States

Site Status

Riverside Methodist Hospital

Columbus, Ohio, United States

Site Status

Mercy Cancer Center-Elyria

Elyria, Ohio, United States

Site Status

Toledo Clinic Cancer Centers-Maumee

Maumee, Ohio, United States

Site Status

Saint Charles Hospital

Oregon, Ohio, United States

Site Status

Mercy Health Perrysburg Cancer Center

Perrysburg, Ohio, United States

Site Status

ProMedica Flower Hospital

Sylvania, Ohio, United States

Site Status

University of Toledo

Toledo, Ohio, United States

Site Status

Mercy Saint Anne Hospital

Toledo, Ohio, United States

Site Status

Toledo Clinic Cancer Centers-Toledo

Toledo, Ohio, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Saint John Medical Center

Tulsa, Oklahoma, United States

Site Status

Saint Charles Health System

Bend, Oregon, United States

Site Status

Clackamas Radiation Oncology Center

Clackamas, Oregon, United States

Site Status

Legacy Mount Hood Medical Center

Gresham, Oregon, United States

Site Status

Providence Newberg Medical Center

Newberg, Oregon, United States

Site Status

Providence Willamette Falls Medical Center

Oregon City, Oregon, United States

Site Status

Legacy Good Samaritan Hospital and Medical Center

Portland, Oregon, United States

Site Status

Providence Portland Medical Center

Portland, Oregon, United States

Site Status

Providence Saint Vincent Medical Center

Portland, Oregon, United States

Site Status

Kaiser Permanente Northwest

Portland, Oregon, United States

Site Status

Legacy Meridian Park Hospital

Tualatin, Oregon, United States

Site Status

Lehigh Valley Hospital-Cedar Crest

Allentown, Pennsylvania, United States

Site Status

Lehigh Valley Hospital - Muhlenberg

Bethlehem, Pennsylvania, United States

Site Status

Geisinger Medical Center

Danville, Pennsylvania, United States

Site Status

Adams Cancer Center

Gettysburg, Pennsylvania, United States

Site Status

Cherry Tree Cancer Center

Hanover, Pennsylvania, United States

Site Status

Geisinger Wyoming Valley/Henry Cancer Center

Wilkes-Barre, Pennsylvania, United States

Site Status

WellSpan Health-York Hospital

York, Pennsylvania, United States

Site Status

AnMed Health Cancer Center

Anderson, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Easley

Easley, South Carolina, United States

Site Status

Gibbs Cancer Center-Gaffney

Gaffney, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Andrews

Greenville, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Butternut

Greenville, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Faris

Greenville, South Carolina, United States

Site Status

Greenville Memorial Hospital

Greenville, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Eastside

Greenville, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Greer

Greer, South Carolina, United States

Site Status

Gibbs Cancer Center-Pelham

Greer, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Seneca

Seneca, South Carolina, United States

Site Status

Spartanburg Medical Center

Spartanburg, South Carolina, United States

Site Status

Greenville Health System Cancer Institute-Spartanburg

Spartanburg, South Carolina, United States

Site Status

Avera Cancer Institute-Aberdeen

Aberdeen, South Dakota, United States

Site Status

Rapid City Regional Hospital

Rapid City, South Dakota, United States

Site Status

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Site Status

Regional Cancer Center at Indian Path Community Hospital

Kingsport, Tennessee, United States

Site Status

Thompson Cancer Survival Center

Knoxville, Tennessee, United States

Site Status

Thompson Cancer Survival Center - West

Knoxville, Tennessee, United States

Site Status

Thompson Oncology Group-Lenoir City

Lenoir City, Tennessee, United States

Site Status

Thompson Oncology Group-Oak Ridge

Oak Ridge, Tennessee, United States

Site Status

Dell Seton Medical Center at The University of Texas

Austin, Texas, United States

Site Status

Austin Cancer Centers-Central Austin

Austin, Texas, United States

Site Status

Austin Cancer Centers-North

Austin, Texas, United States

Site Status

UT Southwestern/Simmons Cancer Center-Dallas

Dallas, Texas, United States

Site Status

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

Huntsman Cancer Institute/University of Utah

Salt Lake City, Utah, United States

Site Status

Kaiser Permanente Tysons Corner Medical Center

McLean, Virginia, United States

Site Status

Southwest VA Regional Cancer Center

Norton, Virginia, United States

Site Status

Providence Regional Cancer System-Aberdeen

Aberdeen, Washington, United States

Site Status

MultiCare Auburn Medical Center

Auburn, Washington, United States

Site Status

PeaceHealth Saint Joseph Medical Center

Bellingham, Washington, United States

Site Status

Harrison HealthPartners Hematology and Oncology-Bremerton

Bremerton, Washington, United States

Site Status

Highline Medical Center-Main Campus

Burien, Washington, United States

Site Status

Providence Regional Cancer System-Centralia

Centralia, Washington, United States

Site Status

MultiCare Gig Harbor Medical Park

Gig Harbor, Washington, United States

Site Status

Providence Regional Cancer System-Lacey

Lacey, Washington, United States

Site Status

PeaceHealth Saint John Medical Center

Longview, Washington, United States

Site Status

Jefferson Healthcare

Port Townsend, Washington, United States

Site Status

MultiCare Good Samaritan Hospital

Puyallup, Washington, United States

Site Status

Swedish Medical Center-Cherry Hill

Seattle, Washington, United States

Site Status

Providence Regional Cancer System-Shelton

Shelton, Washington, United States

Site Status

MultiCare Tacoma General Hospital

Tacoma, Washington, United States

Site Status

Northwest NCI Community Oncology Research Program

Tacoma, Washington, United States

Site Status

PeaceHealth Southwest Medical Center

Vancouver, Washington, United States

Site Status

Legacy Salmon Creek Hospital

Vancouver, Washington, United States

Site Status

North Star Lodge Cancer Center at Yakima Valley Memorial Hospital

Yakima, Washington, United States

Site Status

Providence Regional Cancer System-Yelm

Yelm, Washington, United States

Site Status

West Virginia University Healthcare

Morgantown, West Virginia, United States

Site Status

Aurora Health Center-Fond du Lac

Fond du Lac, Wisconsin, United States

Site Status

Green Bay Oncology at Saint Vincent Hospital

Green Bay, Wisconsin, United States

Site Status

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States

Site Status

Green Bay Oncology Limited at Saint Mary's Hospital

Green Bay, Wisconsin, United States

Site Status

Saint Vincent Hospital Cancer Center at Saint Mary's

Green Bay, Wisconsin, United States

Site Status

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

Site Status

Gundersen Lutheran Medical Center

La Crosse, Wisconsin, United States

Site Status

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Site Status

Holy Family Memorial Hospital

Manitowoc, Wisconsin, United States

Site Status

Marshfield Medical Center-Marshfield

Marshfield, Wisconsin, United States

Site Status

Aurora Saint Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Froedtert and the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Marshfield Clinic-Minocqua Center

Minocqua, Wisconsin, United States

Site Status

ProHealth D N Greenwald Center

Mukwonago, Wisconsin, United States

Site Status

ProHealth Oconomowoc Memorial Hospital

Oconomowoc, Wisconsin, United States

Site Status

Vince Lombardi Cancer Clinic - Oshkosh

Oshkosh, Wisconsin, United States

Site Status

Marshfield Medical Center-Rice Lake

Rice Lake, Wisconsin, United States

Site Status

HSHS Saint Nicholas Hospital

Sheboygan, Wisconsin, United States

Site Status

Marshfield Clinic Stevens Point Center

Stevens Point, Wisconsin, United States

Site Status

ProHealth Waukesha Memorial Hospital

Waukesha, Wisconsin, United States

Site Status

UW Cancer Center at ProHealth Care

Waukesha, Wisconsin, United States

Site Status

Marshfield Clinic - Weston Center

Weston, Wisconsin, United States

Site Status

Billings Clinic-Cody

Cody, Wyoming, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 34882169 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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N10C3

Identifier Type: -

Identifier Source: secondary_id

NCI-2012-02020

Identifier Type: REGISTRY

Identifier Source: secondary_id

U10CA037404

Identifier Type: NIH

Identifier Source: secondary_id

View Link

U10CA037447

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UG1CA189823

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A221101

Identifier Type: -

Identifier Source: org_study_id

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