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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Arm I - Armodafinil

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

Arm II - Placebo

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


Participant Flow:   Overall Study
    Arm I - Armodafinil   Arm II - Placebo
STARTED   26   28 
COMPLETED   22   21 
NOT COMPLETED   4   7 
Death                1                1 
Withdrawal by Subject                1                3 
Toxicity                0                2 
Progression                1                0 
Multiple                1                1 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
All randomized participants.

Reporting Groups
  Description
Arm I - Armodafinil

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

Arm II - Placebo

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 Total of all reporting groups

Baseline Measures
   Arm I - Armodafinil   Arm II - Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   28   54 
Age 
[Units: Participants]
Count of 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 
[Units: Years]
Median (Full Range)
 59 
 (28 to 78) 
 58 
 (29 to 79) 
 59 
 (20 to 79) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      14  53.8%      15  53.6%      29  53.7% 
Male      12  46.2%      13  46.4%      25  46.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Participants]
     
United States   26   28   54 


  Outcome Measures

1.  Primary:   Retention   [ Time Frame: 4 weeks post-RT (approximately 3 months post randomization) ]

2.  Primary:   Adherence   [ Time Frame: 4 weeks post-RT (approximately 3 months post randomization) ]

3.  Secondary:   Fatigue   [ Time Frame: 4 weeks post-RT ]

4.  Secondary:   Sleepiness   [ Time Frame: 4 weeks post-RT ]

5.  Secondary:   HVLT-IR   [ Time Frame: 4 weeks post-RT ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: dcase@wakehealth.edu



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