Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma
Status: | Recruiting |
---|---|
Conditions: | Other Indications, Brain Cancer |
Therapuetic Areas: | Oncology, Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/7/2019 |
Start Date: | June 2013 |
Contact: | Alyx B. Porter Umphrey, MD |
Phone: | (507) 266-5230 |
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.
cancer-related fatigue in patients with high grade glioma. Armodafinil may help relieve
fatigue in patients with high grade glioma.
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.
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.
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
We found this trial at
365
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Chanute, Kansas 66720
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Chesterfield, Missouri 63017
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Chicago, Illinois 60611
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9280 SE Sunnybrook Blvd #100
Clackamas, Oregon 97015
Clackamas, Oregon 97015
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12495 University Ave
Clive, Iowa 50325
Clive, Iowa 50325
(515) 358-9700
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Phone: 406-969-6060
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6001 E Woodmen Rd
Colorado Springs, Colorado 80923
Colorado Springs, Colorado 80923
(719) 776-5000
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
Penrose-Saint Francis Healthcare Founded by the Sisters of St. Francis and the Sisters of Charity,...
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Colorado Springs, Colorado 80907
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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1 Hospital Dr
Columbia, Missouri 65212
Columbia, Missouri 65212
(573) 882-2100
![Ellis Fischel Cancer Center](/wp-content/uploads/logos/university-of-missouri-ellis-fischel.jpg)
Principal Investigator: Tolga Tuncer
Phone: 573-882-7440
University of Missouri-Ellis Fischel Ellis Fischel Cancer Center's team of physician specialists and other trained...
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3535 Olentangy River Rd
Columbus, Ohio 43214
Columbus, Ohio 43214
(614) 566-5000
![Riverside Methodist Hospital](/wp-content/uploads/logos/riverside-methodist-hospital.jpg)
Principal Investigator: Timothy D. Moore
Phone: 614-566-4475
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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Concord, New Hampshire 03301
Principal Investigator: Jeanna H. Walsh
Phone: 603-224-2556
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4050 Coon Rapids Blvd NW
Coon Rapids, Minnesota 55433
Coon Rapids, Minnesota 55433
(763) 236-6000
![Mercy Hospital](/wp-content/uploads/logos/mercy-hospital.png)
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
Mercy Hospital Mercy Hospital, located in Coon Rapids, Minnesota, is a 271-bed non-profit hospital that...
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Corbin, Kentucky 40701
Principal Investigator: Firas B. Badin
Phone: 859-523-1934
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Creston, Iowa 50801
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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Dallas, Texas 75390
Principal Investigator: Edward Pan
Phone: 214-648-7097
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Danville, Illinois 61832
Principal Investigator: Maria T. Grosse-Perdekamp
Phone: 800-446-5532
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100 North Academy Avenue
Danville, Pennsylvania 17822
Danville, Pennsylvania 17822
570-271-6211
![Geisinger Medical Center](/wp-content/uploads/logos/geisinger-medical-center.jpg)
Principal Investigator: Scott G. Turner
Phone: 570-271-5251
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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2300 N Edward St
Decatur, Illinois 62526
Decatur, Illinois 62526
(217) 876-8121
![Decatur Memorial Hospital](/wp-content/uploads/logos/decatur-memorial-hospital.jpg)
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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210 West McKinley Avenue
Decatur, Illinois 62526
Decatur, Illinois 62526
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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1111 6th Ave
Des Moines, Iowa 50314
Des Moines, Iowa 50314
(515) 247-3121
![Mercy Medical Center - Des Moines](/wp-content/uploads/logos/mercy-medical-center---des-moines.jpg)
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
Mercy Medical Center - Des Moines Mercy Medical Center
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Des Moines, Iowa 50314
Principal Investigator: Mehmet S. Copur
Phone: 308-398-6518
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Detroit, Michigan 48236
Principal Investigator: Samir Narayan
Phone: 734-712-3671
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2020 Central Ave
Dodge City, Kansas 67801
Dodge City, Kansas 67801
(620) 227-2488
![Cancer Center of Kansas, PA - Dodge City](/wp-content/uploads/logos/cancer-center-of-kansas-pa---dodge-city.jpg)
Principal Investigator: Shaker R. Dakhil
Phone: 316-268-5374
Cancer Center of Kansas, PA - Dodge City Dr. H.E. Hynes founded Cancer Center of...
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Duluth, Minnesota 55805
Principal Investigator: Bret E. Friday
Phone: 218-786-3308
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Easley, South Carolina 29640
Principal Investigator: Michael D. Zurenko
Phone: 864-241-6251
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East Syracuse, New York 13057
Principal Investigator: Jeffrey J. Kirshner
Phone: 315-472-7504
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6401 France Ave S
Edina, Minnesota 55435
Edina, Minnesota 55435
(952) 924-5000
![Fairview Southdale Hospital](/wp-content/uploads/logos/fairview-southdale-hospital.gif)
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
Fairview Southdale Hospital Fairview Health Services is an award-winning nonprofit health care system based in...
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Effingham, Illinois 62401
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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Effingham, Illinois 62401
Principal Investigator: Maria T. Grosse-Perdekamp
Phone: 800-446-5532
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700 West Central
El Dorado, Kansas 67042
El Dorado, Kansas 67042
(316) 889-0099
![Cancer Center of Kansas, PA - El Dorado](/wp-content/uploads/logos/cancer-center-of-kansas-pa---el-dorado.jpg)
Principal Investigator: Shaker R. Dakhil
Phone: 316-268-5374
Cancer Center of Kansas, PA - El Dorado Dr. H.E. Hynes founded Cancer Center of...
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Elkhart General Hospital For over 100 years, the highly skilled professionals of Elkhart General Hospital...
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Elkhart Clinic, LLC Informed participation in the management of your health care maximizes your Elkhart...
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500 Arcade Blvd, Ste 240
Elkhart, Indiana 46514
Elkhart, Indiana 46514
574-389-0414
![Michiana Hematology-Oncology](/wp-content/uploads/logos/michiana-hematology-oncology.jpg)
Phone: 574-647-6343
Michiana Hematology-Oncology The Advanced Center for Cancer Care in Plymouth is part of the Cancer...
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