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Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors

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ClinicalTrials.gov Identifier: NCT01032200
Recruitment Status : Completed
First Posted : December 15, 2009
Results First Posted : February 13, 2017
Last Update Posted : September 10, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Brain Tumors
Nervous System Tumors
Cognition Disorders
Fatigue
Interventions Drug: Armodafinil
Other: placebo
Enrollment 54
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I - Armodafinil Arm II - Placebo
Hide Arm/Group Description

Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.

Armodafinil: Given orally

Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.

placebo: Given orally

Period Title: Overall Study
Started 26 28
Completed 22 21
Not Completed 4 7
Reason Not Completed
Death             1             1
Withdrawal by Subject             1             3
Toxicity             0             2
Progression             1             0
Multiple             1             1
Arm/Group Title Arm I - Armodafinil Arm II - Placebo Total
Hide Arm/Group Description

Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.

Armodafinil: Given orally

Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.

placebo: Given orally

Total of all reporting groups
Overall Number of Baseline Participants 26 28 54
Hide Baseline Analysis Population Description
All randomized participants.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 28 participants 54 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
  73.1%
18
  64.3%
37
  68.5%
>=65 years
7
  26.9%
10
  35.7%
17
  31.5%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 26 participants 28 participants 54 participants
59
(28 to 78)
58
(29 to 79)
59
(20 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 28 participants 54 participants
Female
14
  53.8%
15
  53.6%
29
  53.7%
Male
12
  46.2%
13
  46.4%
25
  46.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 28 participants 54 participants
Hispanic or Latino
1
   3.8%
0
   0.0%
1
   1.9%
Not Hispanic or Latino
25
  96.2%
28
 100.0%
53
  98.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 26 participants 28 participants 54 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   3.6%
1
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
2
   7.1%
2
   3.7%
White
26
 100.0%
25
  89.3%
51
  94.4%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 26 participants 28 participants 54 participants
26 28 54
1.Primary Outcome
Title Retention
Hide Description Retention is defined as the percentage of participants who complete the 4 week post-RT questionnaires.
Time Frame 4 weeks post-RT (approximately 3 months post randomization)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants
Arm/Group Title Arm I - Armodafinil Arm II - Placebo
Hide Arm/Group Description:

Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.

Armodafinil: Given orally

Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.

placebo: Given orally

Overall Number of Participants Analyzed 26 28
Measure Type: Number
Unit of Measure: percentage of participants
85 75
2.Primary Outcome
Title Adherence
Hide Description Adherence is the percentage of ideal number of pills taken while on study (based on returned diaries)
Time Frame 4 weeks post-RT (approximately 3 months post randomization)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants who returned pill diaries
Arm/Group Title Arm I - Armodafinil Arm II - Placebo
Hide Arm/Group Description:

Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.

Armodafinil: Given orally

Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.

placebo: Given orally

Overall Number of Participants Analyzed 22 25
Mean (Full Range)
Unit of Measure: percentage of ideal number of pills
92.6
(0 to 100)
95.7
(70.3 to 100)
3.Secondary Outcome
Title Fatigue
Hide Description Fatigue is measured by the fatigue subscale of the Functional Assessment of Chronic Illness Therapy Questionnaire. It consists of 13 questions each answered on a 0 to 4 scale. The fatigue score is the sum of the responses with some questions reverse scored. The total Score ranges from 0 to 52, with higher scores indicating less fatigue.
Time Frame 4 weeks post-RT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with any data
Arm/Group Title Arm I - Armodafinil Arm II - Placebo
Hide Arm/Group Description:

Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.

Armodafinil: Given orally

Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.

placebo: Given orally

Overall Number of Participants Analyzed 26 27
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
32.4  (2.6) 36.4  (2.5)
4.Secondary Outcome
Title Sleepiness
Hide Description Sleepiness as measured by the Epworth Sleep Scale. It consists of 8 questions that measure daytime sleepiness in which the patient records their likelihood of dozing or sleeping during a number of routine daily activities. ESS scores range from 0 to 24. Higher scores denote greater sleepiness.
Time Frame 4 weeks post-RT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with any data
Arm/Group Title Arm I - Armodafinil Arm II - Placebo
Hide Arm/Group Description:

Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.

Armodafinil: Given orally

Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.

placebo: Given orally

Overall Number of Participants Analyzed 26 27
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
7.2  (1.0) 8.3  (1.0)
5.Secondary Outcome
Title HVLT-IR
Hide Description HVLT-IR is the Hopkins Verbal learning test - immediate recall. Participants are given 12 words to remember. They are then asked to recall those words. This is repeated 3 times. Minimum recalled words 0 maximum 36. The HVLT-IR score is the sum of correctly recalled words across the three trials. Higher scores indicate better recall.
Time Frame 4 weeks post-RT
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Participants with any data
Arm/Group Title Arm I - Armodafinil Arm II - Placebo
Hide Arm/Group Description:

Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.

Armodafinil: Given orally

Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.

placebo: Given orally

Overall Number of Participants Analyzed 26 27
Least Squares Mean (Standard Error)
Unit of Measure: number of correctly recalled words
21.2  (1.5) 20.0  (1.4)
Time Frame 3 months
Adverse Event Reporting Description The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
 
Arm/Group Title Arm I - Armodafinil Arm II - Placebo
Hide Arm/Group Description

Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.

Armodafinil: Given orally

Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity.

placebo: Given orally

All-Cause Mortality
Arm I - Armodafinil Arm II - Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   1/26 (3.85%)      2/28 (7.14%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I - Armodafinil Arm II - Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/26 (38.46%)      8/27 (29.63%)    
Blood and lymphatic system disorders     
Anemia  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Febrile Neutropenia  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Cardiac disorders     
Acute Coronary Syndrome  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Chest Pain  1  1/26 (3.85%)  1 1/27 (3.70%)  1
Hypertension  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Eye disorders     
Optic Nerve Disorder  1  1/26 (3.85%)  3 0/27 (0.00%)  0
photophobia  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Gastrointestinal disorders     
Diarrhea  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Nausea  1  1/26 (3.85%)  1 2/27 (7.41%)  2
Vomiting  1  1/26 (3.85%)  1 0/27 (0.00%)  0
General disorders     
Agitation  1  0/26 (0.00%)  0 2/27 (7.41%)  2
Anxiety  1  1/26 (3.85%)  1 1/27 (3.70%)  2
Death NOS  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Delirium  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Dizziness  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Fall  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Fatigue  1  0/26 (0.00%)  0 1/27 (3.70%)  3
Pain  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Hepatobiliary disorders     
Alanine Aminotransferase Increased  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Infections and infestations     
Infections and Infestations - Other  1  0/26 (0.00%)  0 2/27 (7.41%)  2
Lung Infection  1  1/26 (3.85%)  1 1/27 (3.70%)  1
Urinary Tract Infection  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Metabolism and nutrition disorders     
Hypoglycemia  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Musculoskeletal and connective tissue disorders     
Muscle Weakness - left-sided  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Muscle Weakness - lower limb  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Nervous system disorders     
Headache  1  2/26 (7.69%)  2 1/27 (3.70%)  2
Psychiatric disorders     
Confusion  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Depression  1  0/26 (0.00%)  0 1/27 (3.70%)  2
Personality Change  1  0/26 (0.00%)  0 1/27 (3.70%)  1
Renal and urinary disorders     
Hematuria  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Vascular disorders     
Stroke  1  1/26 (3.85%)  1 0/27 (0.00%)  0
Thromboembolic Event  1  1/26 (3.85%)  1 0/27 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm I - Armodafinil Arm II - Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/26 (100.00%)      27/27 (100.00%)    
Cardiac disorders     
Hypertension  1  3/26 (11.54%)  7 5/27 (18.52%)  21
Ear and labyrinth disorders     
Dizziness  1  9/26 (34.62%)  24 8/27 (29.63%)  32
Ear and Labyrinth - Other  1  0/26 (0.00%)  0 2/27 (7.41%)  2
Eye disorders     
Blurred Vision  1  4/26 (15.38%)  11 2/27 (7.41%)  3
Eye Disorders - Other  1  5/26 (19.23%)  15 0/27 (0.00%)  0
Gastrointestinal disorders     
Constipation  1  4/26 (15.38%)  6 4/27 (14.81%)  7
Diarrhea  1  0/26 (0.00%)  0 3/27 (11.11%)  4
Dry Mouth  1  9/26 (34.62%)  32 9/27 (33.33%)  45
Dyspepsia  1  2/26 (7.69%)  2 0/27 (0.00%)  0
Nausea  1  12/26 (46.15%)  35 13/27 (48.15%)  23
General disorders     
Back Pain  1  2/26 (7.69%)  3 3/27 (11.11%)  7
Edema Limbs  1  0/26 (0.00%)  0 2/27 (7.41%)  2
Fatigue  1  17/26 (65.38%)  95 17/27 (62.96%)  71
Gait Disturbance  1  0/26 (0.00%)  0 2/27 (7.41%)  2
Headache  1  19/26 (73.08%)  93 16/27 (59.26%)  53
Localized Edema  1  2/26 (7.69%)  12 3/27 (11.11%)  15
Pain  1  3/26 (11.54%)  10 2/27 (7.41%)  2
Infections and infestations     
Mucosal Infection  1  4/26 (15.38%)  16 0/27 (0.00%)  0
Sinusitis  1  0/26 (0.00%)  0 3/27 (11.11%)  3
Investigations     
Investigations - Other  1  0/26 (0.00%)  0 2/27 (7.41%)  2
Musculoskeletal and connective tissue disorders     
Arthralgia  1  3/26 (11.54%)  6 7/27 (25.93%)  18
Generalized Muscle Weakness  1  0/26 (0.00%)  0 3/27 (11.11%)  8
Nervous system disorders     
Tremor  1  0/26 (0.00%)  0 2/27 (7.41%)  11
Psychiatric disorders     
Anxiety  1  15/26 (57.69%)  55 10/27 (37.04%)  39
Cognitive Disturbance  1  0/26 (0.00%)  0 2/27 (7.41%)  10
Confusion  1  3/26 (11.54%)  21 0/27 (0.00%)  0
Insomnia  1  12/26 (46.15%)  46 14/27 (51.85%)  63
Memory Impairment  1  0/26 (0.00%)  0 5/27 (18.52%)  17
Renal and urinary disorders     
Urinary Frequency  1  0/26 (0.00%)  0 2/27 (7.41%)  8
Respiratory, thoracic and mediastinal disorders     
Cough  1  0/26 (0.00%)  0 2/27 (7.41%)  3
Dyspnea  1  2/26 (7.69%)  7 0/27 (0.00%)  0
Sore Throat  1  6/26 (23.08%)  9 5/27 (18.52%)  5
Upper Respiratory Infection  1  2/26 (7.69%)  7 3/27 (11.11%)  5
Skin and subcutaneous tissue disorders     
Alopecia  1  5/26 (19.23%)  11 6/27 (22.22%)  15
Dermatitis Radiation  1  0/26 (0.00%)  0 2/27 (7.41%)  4
Pruritis  1  2/26 (7.69%)  7 2/27 (7.41%)  3
Rash Masculo-Papular  1  7/26 (26.92%)  15 0/27 (0.00%)  0
Skin and Subcutaneous Tissue Disorders - Other  1  0/26 (0.00%)  0 2/27 (7.41%)  2
Vascular disorders     
Thromboembolic Event  1  3/26 (11.54%)  6 0/27 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Doug Case
Organization: Wake Forest NCORP Research Base
Phone: (336) 716-1048
Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT01032200     History of Changes
Other Study ID Numbers: IRB00012856
U10CA081851 ( U.S. NIH Grant/Contract )
REBACCCWFU97509 ( Other Identifier: NCI )
First Submitted: December 13, 2009
First Posted: December 15, 2009
Results First Submitted: November 3, 2016
Results First Posted: February 13, 2017
Last Update Posted: September 10, 2018