Armodafinil in Reducing Cancer-Related Fatigue in Patients With High Grade Glioma
Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT01781468
Collaborator
National Cancer Institute (NCI) (NIH)
328
365
3
78.5
0.9
0
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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.
-
To evaluate the tolerability at 8 weeks of 150 mg and 250 mg armodafinil in this patient population.
-
To assess the effect of armodafinil at 8 weeks on cognitive function in patients with high grade glioma.
-
To assess the impact of armodafinil on global quality of life and other fatigue endpoints in this patient population with high grade glioma.
-
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
328 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Supportive Care
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
Actual Study Start Date
:
Jun 1, 2013
Actual Primary Completion Date
:
May 1, 2019
Actual Study Completion Date
:
Dec 15, 2019
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm I Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks. |
Drug: armodafinil 150 mg
given orally
|
| Placebo Comparator: Arm II Patients receive placebo orally every day in the morning for 8 weeks. |
Other: Placebo
given orally
|
| Experimental: Arm III Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks. |
Drug: armodafinil 250 mg
given orally
|
Outcome Measures
Primary Outcome Measures
- The Number of Participants With a Response in Terms of a Clinically Meaningful Improvement in Patient-reported Fatigue at 8 Weeks. [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
Secondary Outcome Measures
- 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. [Up to 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
- Cognitive Function: Assessed by the Change in Z Score for Symbol Digit Modalities Test (SDMT) From Baseline to End of Week 8 [Up to 8 weeks]
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.
- Change in Quality of Life as Measured by Linear Analogue Self Assessment (LASA) From Baseline to End of Weeks 4 and 8 [Up to 8 weeks]
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.
- 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 [Up to 8 weeks]
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
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alaska Breast Care and Surgery LLC | Anchorage | Alaska | United States | 99508 |
| 2 | Alaska Women's Cancer Care | Anchorage | Alaska | United States | 99508 |
| 3 | Anchorage Oncology Centre | Anchorage | Alaska | United States | 99508 |
| 4 | Katmai Oncology Group | Anchorage | Alaska | United States | 99508 |
| 5 | Providence Alaska Medical Center | Anchorage | Alaska | United States | 99508 |
| 6 | Fairbanks Memorial Hospital | Fairbanks | Alaska | United States | 99701 |
| 7 | Saint Joseph's Hospital and Medical Center | Phoenix | Arizona | United States | 85013 |
| 8 | Arizona Oncology-Deer Valley Center | Phoenix | Arizona | United States | 85027 |
| 9 | Mayo Clinic in Arizona | Scottsdale | Arizona | United States | 85259 |
| 10 | Arizona Oncology Services Foundation | Scottsdale | Arizona | United States | 85260 |
| 11 | Alta Bates Summit Medical Center-Herrick Campus | Berkeley | California | United States | 94704 |
| 12 | Providence Saint Joseph Medical Center/Disney Family Cancer Center | Burbank | California | United States | 91505 |
| 13 | Mills-Peninsula Medical Center | Burlingame | California | United States | 94010 |
| 14 | Community Cancer Institute | Clovis | California | United States | 93611 |
| 15 | University Oncology Associates | Clovis | California | United States | 93611 |
| 16 | John Muir Medical Center-Concord Campus | Concord | California | United States | 94520 |
| 17 | UC San Diego Moores Cancer Center | La Jolla | California | United States | 92093 |
| 18 | Loma Linda University Medical Center | Loma Linda | California | United States | 92354 |
| 19 | Memorial Medical Center | Modesto | California | United States | 95355 |
| 20 | Saint Joseph Hospital - Orange | Orange | California | United States | 92868 |
| 21 | UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | United States | 92868 |
| 22 | Kaiser Permanente Medical Center - Santa Clara | Santa Clara | California | United States | 95051 |
| 23 | Kaiser Permanente-Vallejo | Vallejo | California | United States | 94589 |
| 24 | Penrose-Saint Francis Healthcare | Colorado Springs | Colorado | United States | 80907 |
| 25 | Rocky Mountain Cancer Centers-Penrose | Colorado Springs | Colorado | United States | 80907 |
| 26 | SCL Health Lutheran Medical Center | Wheat Ridge | Colorado | United States | 80033 |
| 27 | Helen F Graham Cancer Center | Newark | Delaware | United States | 19713 |
| 28 | Medical Oncology Hematology Consultants PA | Newark | Delaware | United States | 19713 |
| 29 | Regional Hematology and Oncology PA | Newark | Delaware | United States | 19713 |
| 30 | Christiana Care Health System-Christiana Hospital | Newark | Delaware | United States | 19718 |
| 31 | Kaiser Permanente-Capitol Hill Medical Center | Washington | District of Columbia | United States | 20002 |
| 32 | Boca Raton Regional Hospital | Boca Raton | Florida | United States | 33486 |
| 33 | Florida Hospital Memorial Medical Center | Daytona Beach | Florida | United States | 32117 |
| 34 | Lakeland Regional Health Hollis Cancer Center | Lakeland | Florida | United States | 33805 |
| 35 | University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | United States | 33136 |
| 36 | Florida Hospital Orlando | Orlando | Florida | United States | 32803 |
| 37 | Sacred Heart Hospital | Pensacola | Florida | United States | 32504 |
| 38 | Piedmont Hospital | Atlanta | Georgia | United States | 30309 |
| 39 | Northside Hospital | Atlanta | Georgia | United States | 30342 |
| 40 | Augusta University Medical Center | Augusta | Georgia | United States | 30912 |
| 41 | Northeast Georgia Medical Center-Gainesville | Gainesville | Georgia | United States | 30501 |
| 42 | Hawaii Oncology Inc-Pali Momi | 'Aiea | Hawaii | United States | 96701 |
| 43 | Pali Momi Medical Center | 'Aiea | Hawaii | United States | 96701 |
| 44 | The Cancer Center of Hawaii-Pali Momi | 'Aiea | Hawaii | United States | 96701 |
| 45 | Hawaii Cancer Care Inc-POB II | Honolulu | Hawaii | United States | 96813 |
| 46 | Queen's Medical Center | Honolulu | Hawaii | United States | 96813 |
| 47 | Straub Clinic and Hospital | Honolulu | Hawaii | United States | 96813 |
| 48 | University of Hawaii Cancer Center | Honolulu | Hawaii | United States | 96813 |
| 49 | Hawaii Cancer Care Inc-Liliha | Honolulu | Hawaii | United States | 96817 |
| 50 | Hawaii Oncology Inc-Kuakini | Honolulu | Hawaii | United States | 96817 |
| 51 | The Cancer Center of Hawaii-Liliha | Honolulu | Hawaii | United States | 96817 |
| 52 | Saint Alphonsus Cancer Care Center-Boise | Boise | Idaho | United States | 83706 |
| 53 | Kootenai Medical Center | Coeur d'Alene | Idaho | United States | 83814 |
| 54 | Kootenai Cancer Center | Post Falls | Idaho | United States | 83854 |
| 55 | Kootenai Cancer Clinic | Sandpoint | Idaho | United States | 83864 |
| 56 | Illinois CancerCare-Bloomington | Bloomington | Illinois | United States | 61704 |
| 57 | Illinois CancerCare-Canton | Canton | Illinois | United States | 61520 |
| 58 | Illinois CancerCare-Carthage | Carthage | Illinois | United States | 62321 |
| 59 | Centralia Oncology Clinic | Centralia | Illinois | United States | 62801 |
| 60 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 61 | Carle on Vermilion | Danville | Illinois | United States | 61832 |
| 62 | Cancer Care Specialists of Illinois - Decatur | Decatur | Illinois | United States | 62526 |
| 63 | Decatur Memorial Hospital | Decatur | Illinois | United States | 62526 |
| 64 | Carle Physician Group-Effingham | Effingham | Illinois | United States | 62401 |
| 65 | Crossroads Cancer Center | Effingham | Illinois | United States | 62401 |
| 66 | Illinois CancerCare-Eureka | Eureka | Illinois | United States | 61530 |
| 67 | NorthShore University HealthSystem-Evanston Hospital | Evanston | Illinois | United States | 60201 |
| 68 | Illinois CancerCare-Galesburg | Galesburg | Illinois | United States | 61401 |
| 69 | NorthShore University HealthSystem-Glenbrook Hospital | Glenview | Illinois | United States | 60026 |
| 70 | NorthShore University HealthSystem-Highland Park Hospital | Highland Park | Illinois | United States | 60035 |
| 71 | Illinois CancerCare-Kewanee Clinic | Kewanee | Illinois | United States | 61443 |
| 72 | Illinois CancerCare-Macomb | Macomb | Illinois | United States | 61455 |
| 73 | Carle Physician Group-Mattoon/Charleston | Mattoon | Illinois | United States | 61938 |
| 74 | Trinity Medical Center | Moline | Illinois | United States | 61265 |
| 75 | Good Samaritan Regional Health Center | Mount Vernon | Illinois | United States | 62864 |
| 76 | Illinois CancerCare-Ottawa Clinic | Ottawa | Illinois | United States | 61350 |
| 77 | Illinois CancerCare-Pekin | Pekin | Illinois | United States | 61554 |
| 78 | Illinois CancerCare-Peoria | Peoria | Illinois | United States | 61615 |
| 79 | Methodist Medical Center of Illinois | Peoria | Illinois | United States | 61636 |
| 80 | OSF Saint Francis Medical Center | Peoria | Illinois | United States | 61637 |
| 81 | Illinois CancerCare-Peru | Peru | Illinois | United States | 61354 |
| 82 | Illinois CancerCare-Princeton | Princeton | Illinois | United States | 61356 |
| 83 | Southern Illinois University School of Medicine | Springfield | Illinois | United States | 62702 |
| 84 | Springfield Clinic | Springfield | Illinois | United States | 62702 |
| 85 | Memorial Medical Center | Springfield | Illinois | United States | 62781 |
| 86 | Carle Cancer Center | Urbana | Illinois | United States | 61801 |
| 87 | The Carle Foundation Hospital | Urbana | Illinois | United States | 61801 |
| 88 | Northwestern Medicine Cancer Center Warrenville | Warrenville | Illinois | United States | 60555 |
| 89 | Michiana Hematology Oncology PC-Crown Point | Crown Point | Indiana | United States | 46307 |
| 90 | Elkhart Clinic | Elkhart | Indiana | United States | 46514-2098 |
| 91 | Michiana Hematology Oncology PC-Elkhart | Elkhart | Indiana | United States | 46514 |
| 92 | Elkhart General Hospital | Elkhart | Indiana | United States | 46515 |
| 93 | Community Howard Regional Health | Kokomo | Indiana | United States | 46904 |
| 94 | IU Health La Porte Hospital | La Porte | Indiana | United States | 46350 |
| 95 | Memorial Regional Cancer Center Day Road | Mishawaka | Indiana | United States | 46545 |
| 96 | Michiana Hematology Oncology PC-Mishawaka | Mishawaka | Indiana | United States | 46545 |
| 97 | Saint Joseph Regional Medical Center-Mishawaka | Mishawaka | Indiana | United States | 46545 |
| 98 | Michiana Hematology Oncology PC-Plymouth | Plymouth | Indiana | United States | 46563 |
| 99 | Memorial Hospital of South Bend | South Bend | Indiana | United States | 46601 |
| 100 | Michiana Hematology Oncology PC-South Bend | South Bend | Indiana | United States | 46601 |
| 101 | Michiana Hematology Oncology PC-Westville | Westville | Indiana | United States | 46391 |
| 102 | Mary Greeley Medical Center | Ames | Iowa | United States | 50010 |
| 103 | McFarland Clinic PC - Ames | Ames | Iowa | United States | 50010 |
| 104 | Mercy Hospital | Cedar Rapids | Iowa | United States | 52403 |
| 105 | Oncology Associates at Mercy Medical Center | Cedar Rapids | Iowa | United States | 52403 |
| 106 | Medical Oncology and Hematology Associates-West Des Moines | Clive | Iowa | United States | 50325 |
| 107 | Mercy Cancer Center-West Lakes | Clive | Iowa | United States | 50325 |
| 108 | Greater Regional Medical Center | Creston | Iowa | United States | 50801 |
| 109 | Medical Oncology and Hematology Associates-Laurel | Des Moines | Iowa | United States | 50314 |
| 110 | Mercy Medical Center - Des Moines | Des Moines | Iowa | United States | 50314 |
| 111 | Mercy Medical Center - North Iowa | Mason City | Iowa | United States | 50401 |
| 112 | Siouxland Regional Cancer Center | Sioux City | Iowa | United States | 51101 |
| 113 | Mercy Medical Center-West Lakes | West Des Moines | Iowa | United States | 50266 |
| 114 | Cancer Center of Kansas - Chanute | Chanute | Kansas | United States | 66720 |
| 115 | Cancer Center of Kansas - Dodge City | Dodge City | Kansas | United States | 67801 |
| 116 | Cancer Center of Kansas - El Dorado | El Dorado | Kansas | United States | 67042 |
| 117 | Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas | United States | 66701 |
| 118 | Cancer Center of Kansas-Independence | Independence | Kansas | United States | 67301 |
| 119 | Cancer Center of Kansas-Kingman | Kingman | Kansas | United States | 67068 |
| 120 | Lawrence Memorial Hospital | Lawrence | Kansas | United States | 66044 |
| 121 | Cancer Center of Kansas-Liberal | Liberal | Kansas | United States | 67905 |
| 122 | Cancer Center of Kansas-Manhattan | Manhattan | Kansas | United States | 66502 |
| 123 | Cancer Center of Kansas - McPherson | McPherson | Kansas | United States | 67460 |
| 124 | Cancer Center of Kansas - Newton | Newton | Kansas | United States | 67114 |
| 125 | Cancer Center of Kansas - Parsons | Parsons | Kansas | United States | 67357 |
| 126 | Cancer Center of Kansas - Pratt | Pratt | Kansas | United States | 67124 |
| 127 | Cancer Center of Kansas - Salina | Salina | Kansas | United States | 67401 |
| 128 | Cotton O'Neil Cancer Center / Stormont Vail Health | Topeka | Kansas | United States | 66606 |
| 129 | Cancer Center of Kansas - Wellington | Wellington | Kansas | United States | 67152 |
| 130 | Associates In Womens Health | Wichita | Kansas | United States | 67208 |
| 131 | Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita | Kansas | United States | 67208 |
| 132 | Cancer Center of Kansas - Wichita | Wichita | Kansas | United States | 67214 |
| 133 | Via Christi Regional Medical Center | Wichita | Kansas | United States | 67214 |
| 134 | Cancer Center of Kansas - Winfield | Winfield | Kansas | United States | 67156 |
| 135 | Baptist Health Corbin | Corbin | Kentucky | United States | 40701 |
| 136 | Baptist Health Lexington | Lexington | Kentucky | United States | 40503 |
| 137 | University of Kentucky/Markey Cancer Center | Lexington | Kentucky | United States | 40536 |
| 138 | Baptist Health Louisville | Louisville | Kentucky | United States | 40207 |
| 139 | Baptist Health Madisonville/Merle Mahr Cancer Center | Madisonville | Kentucky | United States | 42431 |
| 140 | Baptist Health Paducah | Paducah | Kentucky | United States | 42003 |
| 141 | The NeuroMedical Center-Clinic | Baton Rouge | Louisiana | United States | 70810 |
| 142 | Culicchia Neurological Clinic LLC | Marrero | Louisiana | United States | 70072 |
| 143 | West Jefferson Medical Center | Marrero | Louisiana | United States | 70072 |
| 144 | Louisiana State University Health Science Center | New Orleans | Louisiana | United States | 70112 |
| 145 | Central Maine Medical Center | Lewiston | Maine | United States | 04240 |
| 146 | Kaiser Permanente-Gaithersburg Medical Center | Gaithersburg | Maryland | United States | 20879 |
| 147 | Kaiser Permanente - Largo Medical Center | Largo | Maryland | United States | 20774 |
| 148 | Unspecified Site | Rockville | Maryland | United States | 20852 |
| 149 | Tufts Medical Center | Boston | Massachusetts | United States | 02111 |
| 150 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
| 151 | Saint Joseph Mercy Hospital | Ann Arbor | Michigan | United States | 48106 |
| 152 | Bronson Battle Creek | Battle Creek | Michigan | United States | 49017 |
| 153 | Caro Cancer Center | Caro | Michigan | United States | 48723 |
| 154 | Ascension Saint John Hospital | Detroit | Michigan | United States | 48236 |
| 155 | Genesee Cancer and Blood Disease Treatment Center | Flint | Michigan | United States | 48503 |
| 156 | Genesee Hematology Oncology PC | Flint | Michigan | United States | 48503 |
| 157 | Genesys Hurley Cancer Institute | Flint | Michigan | United States | 48503 |
| 158 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
| 159 | Cancer Research Consortium of West Michigan NCORP | Grand Rapids | Michigan | United States | 49503 |
| 160 | Mercy Health Saint Mary's | Grand Rapids | Michigan | United States | 49503 |
| 161 | Spectrum Health at Butterworth Campus | Grand Rapids | Michigan | United States | 49503 |
| 162 | West Michigan Cancer Center | Kalamazoo | Michigan | United States | 49007 |
| 163 | Saint Mary's Oncology/Hematology Associates of Marlette | Marlette | Michigan | United States | 48453 |
| 164 | UP Health System Hematology Oncology Marquette | Marquette | Michigan | United States | 49855 |
| 165 | UP Health System Marquette | Marquette | Michigan | United States | 49855 |
| 166 | William Beaumont Hospital-Royal Oak | Royal Oak | Michigan | United States | 48073 |
| 167 | Ascension Saint Mary's Hospital | Saginaw | Michigan | United States | 48601 |
| 168 | Oncology Hematology Associates of Saginaw Valley PC | Saginaw | Michigan | United States | 48604 |
| 169 | Lakeland Medical Center Saint Joseph | Saint Joseph | Michigan | United States | 49085 |
| 170 | Marie Yeager Cancer Center | Saint Joseph | Michigan | United States | 49085 |
| 171 | Ascension Providence Hospitals - Southfield | Southfield | Michigan | United States | 48075 |
| 172 | William Beaumont Hospital - Troy | Troy | Michigan | United States | 48085 |
| 173 | Saint John Macomb-Oakland Hospital | Warren | Michigan | United States | 48093 |
| 174 | Saint Mary's Oncology/Hematology Associates of West Branch | West Branch | Michigan | United States | 48661 |
| 175 | Metro Health Hospital | Wyoming | Michigan | United States | 49519 |
| 176 | Fairview Ridges Hospital | Burnsville | Minnesota | United States | 55337 |
| 177 | Mercy Hospital | Coon Rapids | Minnesota | United States | 55433 |
| 178 | Essentia Health Cancer Center | Duluth | Minnesota | United States | 55805 |
| 179 | Fairview-Southdale Hospital | Edina | Minnesota | United States | 55435 |
| 180 | Unity Hospital | Fridley | Minnesota | United States | 55432 |
| 181 | Minnesota Oncology Hematology PA-Maplewood | Maplewood | Minnesota | United States | 55109 |
| 182 | Saint John's Hospital - Healtheast | Maplewood | Minnesota | United States | 55109 |
| 183 | Abbott-Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
| 184 | Hennepin County Medical Center | Minneapolis | Minnesota | United States | 55415 |
| 185 | Health Partners Inc | Minneapolis | Minnesota | United States | 55454 |
| 186 | Monticello Cancer Center | Monticello | Minnesota | United States | 55362 |
| 187 | North Memorial Medical Health Center | Robbinsdale | Minnesota | United States | 55422 |
| 188 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 189 | Park Nicollet Clinic - Saint Louis Park | Saint Louis Park | Minnesota | United States | 55416 |
| 190 | Regions Hospital | Saint Paul | Minnesota | United States | 55101 |
| 191 | United Hospital | Saint Paul | Minnesota | United States | 55102 |
| 192 | Minnesota Oncology Hematology PA-Woodbury | Woodbury | Minnesota | United States | 55125 |
| 193 | Central Care Cancer Center - Bolivar | Bolivar | Missouri | United States | 65613 |
| 194 | Saint Luke's Hospital | Chesterfield | Missouri | United States | 63017 |
| 195 | University of Missouri - Ellis Fischel | Columbia | Missouri | United States | 65212 |
| 196 | Freeman Health System | Joplin | Missouri | United States | 64804 |
| 197 | Saint Luke's Hospital of Kansas City | Kansas City | Missouri | United States | 64111 |
| 198 | Heartland Regional Medical Center | Saint Joseph | Missouri | United States | 64507 |
| 199 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 200 | Mercy Hospital Saint Louis | Saint Louis | Missouri | United States | 63141 |
| 201 | Mercy Hospital Springfield | Springfield | Missouri | United States | 65804 |
| 202 | Billings Clinic Cancer Center | Billings | Montana | United States | 59101 |
| 203 | Benefis Healthcare- Sletten Cancer Institute | Great Falls | Montana | United States | 59405 |
| 204 | Saint Patrick Hospital - Community Hospital | Missoula | Montana | United States | 59802 |
| 205 | CHI Health Saint Francis | Grand Island | Nebraska | United States | 68803 |
| 206 | CHI Health Good Samaritan | Kearney | Nebraska | United States | 68847 |
| 207 | Nebraska Cancer Research Center | Lincoln | Nebraska | United States | 68510 |
| 208 | Alegent Health Bergan Mercy Medical Center | Omaha | Nebraska | United States | 68124 |
| 209 | Alegent Health Lakeside Hospital | Omaha | Nebraska | United States | 68130 |
| 210 | Creighton University Medical Center | Omaha | Nebraska | United States | 68131 |
| 211 | Cancer and Blood Specialists-Henderson | Henderson | Nevada | United States | 89052 |
| 212 | Comprehensive Cancer Centers of Nevada - Henderson | Henderson | Nevada | United States | 89052 |
| 213 | Las Vegas Cancer Center-Henderson | Henderson | Nevada | United States | 89052 |
| 214 | OptumCare Cancer Care at Seven Hills | Henderson | Nevada | United States | 89052 |
| 215 | 21st Century Oncology-Henderson | Henderson | Nevada | United States | 89074 |
| 216 | Comprehensive Cancer Centers of Nevada-Southeast Henderson | Henderson | Nevada | United States | 89074 |
| 217 | Cancer and Blood Specialists-Shadow | Las Vegas | Nevada | United States | 89106 |
| 218 | Radiation Oncology Centers of Nevada Central | Las Vegas | Nevada | United States | 89106 |
| 219 | 21st Century Oncology | Las Vegas | Nevada | United States | 89109 |
| 220 | HealthCare Partners Medical Group Oncology/Hematology-Maryland Parkway | Las Vegas | Nevada | United States | 89109 |
| 221 | HealthCare Partners Medical Group Oncology/Hematology-San Martin | Las Vegas | Nevada | United States | 89113 |
| 222 | Radiation Oncology Centers of Nevada Southeast | Las Vegas | Nevada | United States | 89119 |
| 223 | Cancer Therapy and Integrative Medicine | Las Vegas | Nevada | United States | 89121 |
| 224 | 21st Century Oncology-Vegas Tenaya | Las Vegas | Nevada | United States | 89128 |
| 225 | Ann M Wierman MD LTD | Las Vegas | Nevada | United States | 89128 |
| 226 | Comprehensive Cancer Centers of Nevada - Northwest | Las Vegas | Nevada | United States | 89128 |
| 227 | HealthCare Partners Medical Group Oncology/Hematology-Tenaya | Las Vegas | Nevada | United States | 89128 |
| 228 | Comprehensive Cancer Centers of Nevada-Summerlin | Las Vegas | Nevada | United States | 89144 |
| 229 | Las Vegas Cancer Center-Medical Center | Las Vegas | Nevada | United States | 89148-2405 |
| 230 | 21st Century Oncology-Fort Apache | Las Vegas | Nevada | United States | 89148 |
| 231 | Comprehensive Cancer Centers of Nevada | Las Vegas | Nevada | United States | 89148 |
| 232 | OptumCare Cancer Care at Fort Apache | Las Vegas | Nevada | United States | 89148 |
| 233 | Comprehensive Cancer Centers of Nevada - Central Valley | Las Vegas | Nevada | United States | 89169 |
| 234 | New Hampshire Oncology Hematology PA-Concord | Concord | New Hampshire | United States | 03301 |
| 235 | New Hampshire Oncology Hematology PA-Hooksett | Hooksett | New Hampshire | United States | 03106 |
| 236 | LRGHealthcare-Lakes Region General Hospital | Laconia | New Hampshire | United States | 03246 |
| 237 | Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 238 | Robert Wood Johnson University Hospital Somerset | Somerville | New Jersey | United States | 08876 |
| 239 | Montefiore Medical Center-Einstein Campus | Bronx | New York | United States | 10461 |
| 240 | Montefiore Medical Center - Moses Campus | Bronx | New York | United States | 10467 |
| 241 | Hematology Oncology Associates of Central New York-East Syracuse | East Syracuse | New York | United States | 13057 |
| 242 | NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center | New York | New York | United States | 10032 |
| 243 | Memorial Sloan Kettering Cancer Center | New York | New York | United States | 10065 |
| 244 | Highland Hospital | Rochester | New York | United States | 14620 |
| 245 | University Radiation Oncology | Rochester | New York | United States | 14626 |
| 246 | University of Rochester | Rochester | New York | United States | 14642 |
| 247 | Mission Hospital Inc-Memorial Campus | Asheville | North Carolina | United States | 28801 |
| 248 | Carolinas Medical Center/Levine Cancer Institute | Charlotte | North Carolina | United States | 28203 |
| 249 | Novant Health Presbyterian Medical Center | Charlotte | North Carolina | United States | 28204 |
| 250 | Southeastern Medical Oncology Center-Clinton | Clinton | North Carolina | United States | 28328 |
| 251 | Southeastern Medical Oncology Center-Goldsboro | Goldsboro | North Carolina | United States | 27534 |
| 252 | Wayne Memorial Hospital | Goldsboro | North Carolina | United States | 27534 |
| 253 | AdventHealth Hendersonville | Hendersonville | North Carolina | United States | 28792 |
| 254 | Southeastern Medical Oncology Center-Jacksonville | Jacksonville | North Carolina | United States | 28546 |
| 255 | Novant Health Oncology Specialists-Kernersville | Kernersville | North Carolina | United States | 27284 |
| 256 | Vidant Oncology-Kinston | Kinston | North Carolina | United States | 28501 |
| 257 | Novant Health Oncology Specialists-Mount Airy | Mount Airy | North Carolina | United States | 27030 |
| 258 | Novant Health Oncology Specialists-Statesville | Statesville | North Carolina | United States | 28625 |
| 259 | Novant Health Oncology Specialists-Davidson County | Thomasville | North Carolina | United States | 27360 |
| 260 | Novant Health Oncology Specialists-Wilkesboro | Wilkesboro | North Carolina | United States | 28659 |
| 261 | Southeastern Medical Oncology Center-Wilson | Wilson | North Carolina | United States | 27893 |
| 262 | Novant Health Forsyth Medical Center | Winston-Salem | North Carolina | United States | 27103 |
| 263 | Novant Health Oncology Specialists | Winston-Salem | North Carolina | United States | 27103 |
| 264 | Altru Cancer Center | Grand Forks | North Dakota | United States | 58201 |
| 265 | Cleveland Clinic Akron General | Akron | Ohio | United States | 44307 |
| 266 | Riverside Methodist Hospital | Columbus | Ohio | United States | 43214 |
| 267 | Mercy Cancer Center-Elyria | Elyria | Ohio | United States | 44035 |
| 268 | Toledo Clinic Cancer Centers-Maumee | Maumee | Ohio | United States | 43537 |
| 269 | Saint Charles Hospital | Oregon | Ohio | United States | 43616 |
| 270 | Mercy Health Perrysburg Cancer Center | Perrysburg | Ohio | United States | 43551 |
| 271 | ProMedica Flower Hospital | Sylvania | Ohio | United States | 43560 |
| 272 | University of Toledo | Toledo | Ohio | United States | 43614 |
| 273 | Mercy Saint Anne Hospital | Toledo | Ohio | United States | 43623 |
| 274 | Toledo Clinic Cancer Centers-Toledo | Toledo | Ohio | United States | 43623 |
| 275 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 276 | Saint John Medical Center | Tulsa | Oklahoma | United States | 74104 |
| 277 | Saint Charles Health System | Bend | Oregon | United States | 97701 |
| 278 | Clackamas Radiation Oncology Center | Clackamas | Oregon | United States | 97015 |
| 279 | Legacy Mount Hood Medical Center | Gresham | Oregon | United States | 97030 |
| 280 | Providence Newberg Medical Center | Newberg | Oregon | United States | 97132 |
| 281 | Providence Willamette Falls Medical Center | Oregon City | Oregon | United States | 97045 |
| 282 | Legacy Good Samaritan Hospital and Medical Center | Portland | Oregon | United States | 97210 |
| 283 | Providence Portland Medical Center | Portland | Oregon | United States | 97213 |
| 284 | Providence Saint Vincent Medical Center | Portland | Oregon | United States | 97225 |
| 285 | Kaiser Permanente Northwest | Portland | Oregon | United States | 97227 |
| 286 | Legacy Meridian Park Hospital | Tualatin | Oregon | United States | 97062 |
| 287 | Lehigh Valley Hospital-Cedar Crest | Allentown | Pennsylvania | United States | 18103 |
| 288 | Lehigh Valley Hospital - Muhlenberg | Bethlehem | Pennsylvania | United States | 18017 |
| 289 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822 |
| 290 | Adams Cancer Center | Gettysburg | Pennsylvania | United States | 17325 |
| 291 | Cherry Tree Cancer Center | Hanover | Pennsylvania | United States | 17331 |
| 292 | Geisinger Wyoming Valley/Henry Cancer Center | Wilkes-Barre | Pennsylvania | United States | 18711 |
| 293 | WellSpan Health-York Hospital | York | Pennsylvania | United States | 17403 |
| 294 | AnMed Health Cancer Center | Anderson | South Carolina | United States | 29621 |
| 295 | Greenville Health System Cancer Institute-Easley | Easley | South Carolina | United States | 29640 |
| 296 | Gibbs Cancer Center-Gaffney | Gaffney | South Carolina | United States | 29341 |
| 297 | Greenville Health System Cancer Institute-Andrews | Greenville | South Carolina | United States | 29601 |
| 298 | Greenville Health System Cancer Institute-Butternut | Greenville | South Carolina | United States | 29605 |
| 299 | Greenville Health System Cancer Institute-Faris | Greenville | South Carolina | United States | 29605 |
| 300 | Greenville Memorial Hospital | Greenville | South Carolina | United States | 29605 |
| 301 | Greenville Health System Cancer Institute-Eastside | Greenville | South Carolina | United States | 29615 |
| 302 | Greenville Health System Cancer Institute-Greer | Greer | South Carolina | United States | 29650 |
| 303 | Gibbs Cancer Center-Pelham | Greer | South Carolina | United States | 29651 |
| 304 | Greenville Health System Cancer Institute-Seneca | Seneca | South Carolina | United States | 29672 |
| 305 | Spartanburg Medical Center | Spartanburg | South Carolina | United States | 29303 |
| 306 | Greenville Health System Cancer Institute-Spartanburg | Spartanburg | South Carolina | United States | 29307 |
| 307 | Avera Cancer Institute-Aberdeen | Aberdeen | South Dakota | United States | 57401 |
| 308 | Rapid City Regional Hospital | Rapid City | South Dakota | United States | 57701 |
| 309 | Avera Cancer Institute | Sioux Falls | South Dakota | United States | 57105 |
| 310 | Regional Cancer Center at Indian Path Community Hospital | Kingsport | Tennessee | United States | 37660 |
| 311 | Thompson Cancer Survival Center | Knoxville | Tennessee | United States | 37916 |
| 312 | Thompson Cancer Survival Center - West | Knoxville | Tennessee | United States | 37932 |
| 313 | Thompson Oncology Group-Lenoir City | Lenoir City | Tennessee | United States | 37772 |
| 314 | Thompson Oncology Group-Oak Ridge | Oak Ridge | Tennessee | United States | 37830 |
| 315 | Dell Seton Medical Center at The University of Texas | Austin | Texas | United States | 78701 |
| 316 | Austin Cancer Centers-Central Austin | Austin | Texas | United States | 78702 |
| 317 | Austin Cancer Centers-North | Austin | Texas | United States | 78758 |
| 318 | UT Southwestern/Simmons Cancer Center-Dallas | Dallas | Texas | United States | 75390 |
| 319 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78229 |
| 320 | Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | United States | 84112 |
| 321 | Kaiser Permanente Tysons Corner Medical Center | McLean | Virginia | United States | 22102 |
| 322 | Southwest VA Regional Cancer Center | Norton | Virginia | United States | 24273 |
| 323 | Providence Regional Cancer System-Aberdeen | Aberdeen | Washington | United States | 98520 |
| 324 | MultiCare Auburn Medical Center | Auburn | Washington | United States | 98001 |
| 325 | PeaceHealth Saint Joseph Medical Center | Bellingham | Washington | United States | 98225 |
| 326 | Harrison HealthPartners Hematology and Oncology-Bremerton | Bremerton | Washington | United States | 98310 |
| 327 | Highline Medical Center-Main Campus | Burien | Washington | United States | 98166 |
| 328 | Providence Regional Cancer System-Centralia | Centralia | Washington | United States | 98531 |
| 329 | MultiCare Gig Harbor Medical Park | Gig Harbor | Washington | United States | 98335 |
| 330 | Providence Regional Cancer System-Lacey | Lacey | Washington | United States | 98503 |
| 331 | PeaceHealth Saint John Medical Center | Longview | Washington | United States | 98632 |
| 332 | Jefferson Healthcare | Port Townsend | Washington | United States | 98368 |
| 333 | MultiCare Good Samaritan Hospital | Puyallup | Washington | United States | 98372 |
| 334 | Swedish Medical Center-Cherry Hill | Seattle | Washington | United States | 98122-5711 |
| 335 | Providence Regional Cancer System-Shelton | Shelton | Washington | United States | 98584 |
| 336 | MultiCare Tacoma General Hospital | Tacoma | Washington | United States | 98405 |
| 337 | Northwest NCI Community Oncology Research Program | Tacoma | Washington | United States | 98405 |
| 338 | PeaceHealth Southwest Medical Center | Vancouver | Washington | United States | 98664 |
| 339 | Legacy Salmon Creek Hospital | Vancouver | Washington | United States | 98686 |
| 340 | North Star Lodge Cancer Center at Yakima Valley Memorial Hospital | Yakima | Washington | United States | 98902 |
| 341 | Providence Regional Cancer System-Yelm | Yelm | Washington | United States | 98597 |
| 342 | West Virginia University Healthcare | Morgantown | West Virginia | United States | 26506 |
| 343 | Aurora Health Center-Fond du Lac | Fond Du Lac | Wisconsin | United States | 54937 |
| 344 | Green Bay Oncology at Saint Vincent Hospital | Green Bay | Wisconsin | United States | 54301-3526 |
| 345 | Saint Vincent Hospital Cancer Center Green Bay | Green Bay | Wisconsin | United States | 54301 |
| 346 | Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay | Wisconsin | United States | 54303 |
| 347 | Saint Vincent Hospital Cancer Center at Saint Mary's | Green Bay | Wisconsin | United States | 54303 |
| 348 | Aurora BayCare Medical Center | Green Bay | Wisconsin | United States | 54311 |
| 349 | Gundersen Lutheran Medical Center | La Crosse | Wisconsin | United States | 54601 |
| 350 | University of Wisconsin Hospital and Clinics | Madison | Wisconsin | United States | 53792 |
| 351 | Holy Family Memorial Hospital | Manitowoc | Wisconsin | United States | 54221 |
| 352 | Marshfield Medical Center-Marshfield | Marshfield | Wisconsin | United States | 54449 |
| 353 | Aurora Saint Luke's Medical Center | Milwaukee | Wisconsin | United States | 53215 |
| 354 | Froedtert and the Medical College of Wisconsin | Milwaukee | Wisconsin | United States | 53226 |
| 355 | Marshfield Clinic-Minocqua Center | Minocqua | Wisconsin | United States | 54548 |
| 356 | ProHealth D N Greenwald Center | Mukwonago | Wisconsin | United States | 53149 |
| 357 | ProHealth Oconomowoc Memorial Hospital | Oconomowoc | Wisconsin | United States | 53066 |
| 358 | Vince Lombardi Cancer Clinic - Oshkosh | Oshkosh | Wisconsin | United States | 54904 |
| 359 | Marshfield Medical Center-Rice Lake | Rice Lake | Wisconsin | United States | 54868 |
| 360 | HSHS Saint Nicholas Hospital | Sheboygan | Wisconsin | United States | 53081 |
| 361 | Marshfield Clinic Stevens Point Center | Stevens Point | Wisconsin | United States | 54482 |
| 362 | ProHealth Waukesha Memorial Hospital | Waukesha | Wisconsin | United States | 53188 |
| 363 | UW Cancer Center at ProHealth Care | Waukesha | Wisconsin | United States | 53188 |
| 364 | Marshfield Clinic - Weston Center | Weston | Wisconsin | United States | 54476 |
| 365 | Billings Clinic-Cody | Cody | Wyoming | United States | 82414 |
Sponsors and Collaborators
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
Investigators
- Study Chair: Alyx B. Porter Umphrey, MD, Mayo Clinic
Study Documents (Full-Text)
More Information
Publications
None provided.Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01781468
Other Study ID Numbers:
- A221101
- N10C3
- NCI-2012-02020
- U10CA037404
- U10CA037447
- UG1CA189823
First Posted:
Feb 1, 2013
Last Update Posted:
May 7, 2020
Last Verified:
May 1, 2020
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Arm I (150 mg Armodafinil) | Arm II (250 mg Armodafinil) | Arm III (Placebo) |
|---|---|---|---|
| Arm/Group Description | Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks. | Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks. | Patients receive placebo orally every day in the morning for 8 weeks. |
| Period Title: Overall Study | |||
| STARTED | 109 | 110 | 109 |
| COMPLETED | 103 | 97 | 97 |
| NOT COMPLETED | 6 | 13 | 12 |
Baseline Characteristics
| Arm/Group Title | Arm I (150 mg Armodafinil) | Arm II (250 mg Armodafinil) | Arm III (Placebo) | Total |
|---|---|---|---|---|
| Arm/Group Description | Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks. | Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks. | Patients receive placebo orally every day in the morning for 8 weeks. | Total of all reporting groups |
| Overall Participants | 109 | 110 | 109 | 328 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
58.3
(11.92)
|
56.9
(12.21)
|
56.6
(12.8)
|
57.3
(12.3)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
46
42.2%
|
46
41.8%
|
43
39.4%
|
135
41.2%
|
| Male |
63
57.8%
|
64
58.2%
|
66
60.6%
|
193
58.8%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| White |
101
92.7%
|
105
95.5%
|
104
95.4%
|
310
94.5%
|
| Non-White |
8
7.3%
|
5
4.5%
|
5
4.6%
|
18
5.5%
|
| ECOG Performance Status (Count of Participants) | ||||
| 0 |
18
16.5%
|
28
25.5%
|
23
21.1%
|
69
21%
|
| 1 |
60
55%
|
58
52.7%
|
62
56.9%
|
180
54.9%
|
| 2 |
23
21.1%
|
22
20%
|
16
14.7%
|
61
18.6%
|
| 3 |
8
7.3%
|
2
1.8%
|
8
7.3%
|
18
5.5%
|
Outcome Measures
| Title | The Number of Participants With a Response in Terms of a Clinically Meaningful Improvement in Patient-reported Fatigue at 8 Weeks. |
|---|---|
| Description | 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 |
| Time Frame | At 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who completed the study are included in this analysis. |
| Arm/Group Title | Arm I (150 mg Armodafinil) | Arm II (250 mg Armodafinil) | Arm III (Placebo) |
|---|---|---|---|
| Arm/Group Description | Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks. | Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks. | Patients receive placebo orally every day in the morning for 8 weeks. |
| Measure Participants | 103 | 97 | 97 |
| Count of Participants [Participants] |
29
26.6%
|
27
24.5%
|
29
26.6%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm I (150 mg Armodafinil), Arm II (250 mg Armodafinil), Arm III (Placebo) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9601 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | 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. |
|---|---|
| Description | 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 |
| Time Frame | Up to 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who completed the study are included in this analysis. |
| Arm/Group Title | Arm I (150 mg Armodafinil) | Arm II (250 mg Armodafinil) | Arm III (Placebo) |
|---|---|---|---|
| Arm/Group Description | Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks. | Patients receive 250 mg armodafinil orally every day in the morning for 8 weeks. | Patients receive placebo orally every day in the morning for 8 weeks. |
| Measure Participants | 103 | 97 | 97 |
| Count of Participants [Participants] |
37
33.9%
|
31
28.2%
|
30
27.5%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm I (150 mg Armodafinil), Arm II (250 mg Armodafinil), Arm III (Placebo) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.7877 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Title | Cognitive Function: Assessed by the Change in Z Score for Symbol Digit Modalities Test (SDMT) From Baseline to End of Week 8 |
|---|---|
| Description | 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. |
| Time Frame | Up to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who completed the Symbol Digit Modalities Test at baseline and end of week 8 are included in this analysis. |
| Arm/Group Title | Arm I (150 mg Armodafinil) | Arm II (250 mg Armodafinil) | Arm III (Placebo) |
|---|---|---|---|
| Arm/Group Description | Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks. | Patients receive 250 mg Armodafinil orally every day in the morning for 8 weeks. | Patients receive placebo orally every day in the morning for 8 weeks. |
| Measure Participants | 61 | 55 | 60 |
| Median (Full Range) [units on a scale] |
0.0
|
0.3
|
0.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm I (150 mg Armodafinil), Arm II (250 mg Armodafinil), Arm III (Placebo) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.3272 |
| Comments | ||
| Method | Kruskal-Wallis | |
| Comments | ||
| Title | Change in Quality of Life as Measured by Linear Analogue Self Assessment (LASA) From Baseline to End of Weeks 4 and 8 |
|---|---|
| Description | 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. |
| Time Frame | Up to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants with LASA data available at all specified time points are included in this analysis. The number analyzed in row differ from the Overall number of participants who completed the study due to missing data (i.e. participants did not complete the LASA at either week 4 and/or week 8 time point(s)). |
| Arm/Group Title | Arm I (150 mg Armodafinil) | Arm II (250 mg Armodafinil) | Arm III (Placebo) |
|---|---|---|---|
| Arm/Group Description | Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks. | Patients receive 250 mg Armodafinil orally every day in the morning for 8 weeks. | Patients receive placebo orally every day in the morning for 8 weeks. |
| Measure Participants | 80 | 68 | 84 |
| Baseline to Week 4 |
2.0
|
0.5
|
2.0
|
| Baseline to Week 8 |
4.0
|
3.0
|
2.0
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Arm I (150 mg Armodafinil), Arm II (250 mg Armodafinil), Arm III (Placebo) |
|---|---|---|
| Comments | Baseline to Week 4 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.9122 |
| Comments | ||
| Method | Kruskal-Wallis | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Arm I (150 mg Armodafinil), Arm II (250 mg Armodafinil), Arm III (Placebo) |
|---|---|---|
| Comments | Baseline to Week 8 | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.8559 |
| Comments | ||
| Method | Kruskal-Wallis | |
| Comments | ||
| Title | 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 |
|---|---|
| Description | 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 |
| Time Frame | Up to 8 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Participants who started the study are included in this analysis. |
| Arm/Group Title | Arm I (150 mg Armodafinil) | Arm II (250 mg Armodafinil) | Arm III (Placebo) |
|---|---|---|---|
| Arm/Group Description | Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks. | Patients receive 250 mg Armodafinil orally every day in the morning for 8 weeks. | Patients receive placebo orally every day in the morning for 8 weeks. |
| Measure Participants | 109 | 110 | 109 |
| Count of Participants [Participants] |
6
5.5%
|
8
7.3%
|
3
2.8%
|
Adverse Events
| Time Frame | Up to 8 weeks | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Arm I (150 mg Armodafinil) | Arm II (250 mg Armodafinil) | Arm III (Placebo) | |||
| Arm/Group Description | Patients receive 150 mg armodafinil orally every day in the morning for 8 weeks. | Patients receive 250 mg Armodafinil orally every day in the morning for 8 weeks. | Patients receive placebo orally every day in the morning for 8 weeks. | |||
All Cause Mortality |
||||||
| Arm I (150 mg Armodafinil) | Arm II (250 mg Armodafinil) | Arm III (Placebo) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/109 (0%) | 2/110 (1.8%) | 1/109 (0.9%) | |||
Serious Adverse Events |
||||||
| Arm I (150 mg Armodafinil) | Arm II (250 mg Armodafinil) | Arm III (Placebo) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 12/109 (11%) | 9/110 (8.2%) | 8/109 (7.3%) | |||
| Ear and labyrinth disorders | ||||||
| Vertigo | 1/109 (0.9%) | 1 | 0/110 (0%) | 0 | 0/109 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Abdominal pain | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Mucositis oral | 1/109 (0.9%) | 1 | 0/110 (0%) | 0 | 0/109 (0%) | 0 |
| Nausea | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 1/109 (0.9%) | 1 |
| Vomiting | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 1/109 (0.9%) | 1 |
| General disorders | ||||||
| Fatigue | 0/109 (0%) | 0 | 2/110 (1.8%) | 2 | 0/109 (0%) | 0 |
| Infections and infestations | ||||||
| Sepsis | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Urinary tract infection | 1/109 (0.9%) | 1 | 0/110 (0%) | 0 | 0/109 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| Fall | 2/109 (1.8%) | 2 | 0/110 (0%) | 0 | 1/109 (0.9%) | 1 |
| Spinal fracture | 0/109 (0%) | 0 | 0/110 (0%) | 0 | 1/109 (0.9%) | 1 |
| Investigations | ||||||
| Alanine aminotransferase increased | 0/109 (0%) | 0 | 0/110 (0%) | 0 | 1/109 (0.9%) | 1 |
| Aspartate aminotransferase increased | 0/109 (0%) | 0 | 0/110 (0%) | 0 | 1/109 (0.9%) | 1 |
| Platelet count decreased | 0/109 (0%) | 0 | 0/110 (0%) | 0 | 1/109 (0.9%) | 1 |
| Metabolism and nutrition disorders | ||||||
| Dehydration | 2/109 (1.8%) | 2 | 0/110 (0%) | 0 | 1/109 (0.9%) | 1 |
| Hyponatremia | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Generalized muscle weakness | 2/109 (1.8%) | 2 | 3/110 (2.7%) | 3 | 1/109 (0.9%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Neoplasms benign, mal, uncpec - Oth spec | 0/109 (0%) | 0 | 0/110 (0%) | 0 | 1/109 (0.9%) | 1 |
| Nervous system disorders | ||||||
| Aphonia | 0/109 (0%) | 0 | 1/110 (0.9%) | 2 | 0/109 (0%) | 0 |
| Dizziness | 1/109 (0.9%) | 1 | 0/110 (0%) | 0 | 0/109 (0%) | 0 |
| Edema cerebral | 2/109 (1.8%) | 2 | 0/110 (0%) | 0 | 0/109 (0%) | 0 |
| Headache | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Hydrocephalus | 0/109 (0%) | 0 | 0/110 (0%) | 0 | 1/109 (0.9%) | 1 |
| Hypersomnia | 1/109 (0.9%) | 1 | 0/110 (0%) | 0 | 0/109 (0%) | 0 |
| Lethargy | 0/109 (0%) | 0 | 1/110 (0.9%) | 2 | 0/109 (0%) | 0 |
| Memory impairment | 1/109 (0.9%) | 1 | 0/110 (0%) | 0 | 0/109 (0%) | 0 |
| Movements involuntary | 1/109 (0.9%) | 1 | 0/110 (0%) | 0 | 0/109 (0%) | 0 |
| Muscle weakness right-sided | 0/109 (0%) | 0 | 0/110 (0%) | 0 | 1/109 (0.9%) | 1 |
| Seizure | 1/109 (0.9%) | 1 | 0/110 (0%) | 0 | 2/109 (1.8%) | 2 |
| Psychiatric disorders | ||||||
| Confusion | 1/109 (0.9%) | 1 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnea | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Productive cough | 0/109 (0%) | 0 | 0/110 (0%) | 0 | 1/109 (0.9%) | 1 |
| Vascular disorders | ||||||
| Hypertension | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Thromboembolic event | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 2/109 (1.8%) | 2 |
Other (Not Including Serious) Adverse Events |
||||||
| Arm I (150 mg Armodafinil) | Arm II (250 mg Armodafinil) | Arm III (Placebo) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 55/109 (50.5%) | 60/110 (54.5%) | 42/109 (38.5%) | |||
| Blood and lymphatic system disorders | ||||||
| Anemia | 2/109 (1.8%) | 2 | 0/110 (0%) | 0 | 0/109 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| Abdominal pain | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Diarrhea | 1/109 (0.9%) | 1 | 2/110 (1.8%) | 2 | 1/109 (0.9%) | 1 |
| Dry mouth | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Gastroesophageal reflux disease | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Mucositis oral | 2/109 (1.8%) | 2 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Nausea | 5/109 (4.6%) | 6 | 4/110 (3.6%) | 4 | 1/109 (0.9%) | 1 |
| Oral pain | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Stomach pain | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Vomiting | 1/109 (0.9%) | 1 | 1/110 (0.9%) | 1 | 1/109 (0.9%) | 1 |
| General disorders | ||||||
| Edema limbs | 2/109 (1.8%) | 2 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Fatigue | 9/109 (8.3%) | 9 | 7/110 (6.4%) | 8 | 2/109 (1.8%) | 2 |
| Gait disturbance | 1/109 (0.9%) | 1 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Gen disord and admin site conds-Oth spec | 1/109 (0.9%) | 1 | 0/110 (0%) | 0 | 0/109 (0%) | 0 |
| Pain | 1/109 (0.9%) | 1 | 0/110 (0%) | 0 | 2/109 (1.8%) | 2 |
| Infections and infestations | ||||||
| Upper respiratory infection | 1/109 (0.9%) | 1 | 2/110 (1.8%) | 2 | 1/109 (0.9%) | 1 |
| Urinary tract infection | 1/109 (0.9%) | 1 | 0/110 (0%) | 0 | 0/109 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| Fall | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Hip fracture | 1/109 (0.9%) | 1 | 0/110 (0%) | 0 | 0/109 (0%) | 0 |
| Investigations | ||||||
| Alanine aminotransferase increased | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| GGT increased | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Lymphocyte count decreased | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 1/109 (0.9%) | 2 |
| Neutrophil count decreased | 1/109 (0.9%) | 1 | 0/110 (0%) | 0 | 1/109 (0.9%) | 1 |
| Platelet count decreased | 3/109 (2.8%) | 3 | 0/110 (0%) | 0 | 1/109 (0.9%) | 1 |
| White blood cell decreased | 3/109 (2.8%) | 3 | 0/110 (0%) | 0 | 1/109 (0.9%) | 2 |
| Metabolism and nutrition disorders | ||||||
| Anorexia | 2/109 (1.8%) | 2 | 2/110 (1.8%) | 2 | 2/109 (1.8%) | 2 |
| Hyperglycemia | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 2/109 (1.8%) | 2 |
| Hypoalbuminemia | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Metabolism, nutrition disord - Oth spec | 0/109 (0%) | 0 | 1/110 (0.9%) | 2 | 0/109 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Generalized muscle weakness | 1/109 (0.9%) | 1 | 4/110 (3.6%) | 5 | 1/109 (0.9%) | 2 |
| Muscle weakness lower limb | 0/109 (0%) | 0 | 0/110 (0%) | 0 | 1/109 (0.9%) | 1 |
| Musculoskeletal, conn tissue - Oth spec | 0/109 (0%) | 0 | 1/110 (0.9%) | 2 | 0/109 (0%) | 0 |
| Myalgia | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Neck pain | 0/109 (0%) | 0 | 0/110 (0%) | 0 | 1/109 (0.9%) | 1 |
| Pain in extremity | 0/109 (0%) | 0 | 1/110 (0.9%) | 2 | 0/109 (0%) | 0 |
| Nervous system disorders | ||||||
| Amnesia | 0/109 (0%) | 0 | 0/110 (0%) | 0 | 1/109 (0.9%) | 1 |
| Ataxia | 1/109 (0.9%) | 1 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Dizziness | 2/109 (1.8%) | 2 | 5/110 (4.5%) | 6 | 1/109 (0.9%) | 1 |
| Dysarthria | 0/109 (0%) | 0 | 2/110 (1.8%) | 2 | 0/109 (0%) | 0 |
| Dysgeusia | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Dysphasia | 0/109 (0%) | 0 | 2/110 (1.8%) | 2 | 0/109 (0%) | 0 |
| Headache | 42/109 (38.5%) | 62 | 46/110 (41.8%) | 67 | 35/109 (32.1%) | 54 |
| Hypersomnia | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Lethargy | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Muscle weakness left-sided | 1/109 (0.9%) | 1 | 0/110 (0%) | 0 | 0/109 (0%) | 0 |
| Paresthesia | 0/109 (0%) | 0 | 0/110 (0%) | 0 | 1/109 (0.9%) | 1 |
| Seizure | 1/109 (0.9%) | 1 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Syncope | 0/109 (0%) | 0 | 0/110 (0%) | 0 | 1/109 (0.9%) | 1 |
| Tremor | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 1/109 (0.9%) | 1 |
| Psychiatric disorders | ||||||
| Anxiety | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 1/109 (0.9%) | 1 |
| Confusion | 0/109 (0%) | 0 | 2/110 (1.8%) | 2 | 0/109 (0%) | 0 |
| Depression | 0/109 (0%) | 0 | 2/110 (1.8%) | 3 | 1/109 (0.9%) | 1 |
| Insomnia | 2/109 (1.8%) | 2 | 7/110 (6.4%) | 7 | 0/109 (0%) | 0 |
| Personality change | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Restlessness | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| Dyspnea | 0/109 (0%) | 0 | 2/110 (1.8%) | 3 | 0/109 (0%) | 0 |
| Pneumonitis | 1/109 (0.9%) | 1 | 0/110 (0%) | 0 | 0/109 (0%) | 0 |
| Voice alteration | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| Dry skin | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Pruritus | 1/109 (0.9%) | 1 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Skin and subcut tissue disord - Oth spec | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
| Vascular disorders | ||||||
| Hypertension | 1/109 (0.9%) | 1 | 2/110 (1.8%) | 3 | 0/109 (0%) | 0 |
| Hypotension | 0/109 (0%) | 0 | 0/110 (0%) | 0 | 1/109 (0.9%) | 1 |
| Superficial thrombophlebitis | 0/109 (0%) | 0 | 0/110 (0%) | 0 | 1/109 (0.9%) | 1 |
| Thromboembolic event | 0/109 (0%) | 0 | 1/110 (0.9%) | 1 | 0/109 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Alyx B. Porter Umphrey, M.D. |
|---|---|
| Organization | Mayo Clinic Arizona |
| Phone | 480-301-4062 |
| Porter.alyx@mayo.edu |
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT01781468
Other Study ID Numbers:
- A221101
- N10C3
- NCI-2012-02020
- U10CA037404
- U10CA037447
- UG1CA189823
First Posted:
Feb 1, 2013
Last Update Posted:
May 7, 2020
Last Verified:
May 1, 2020