Armodafinil for Persistent Patient-Reported Fatigue Following Radiation Therapy for Head and Neck Cancer: a Randomized Phase II Study
Armodafinil is designed to stimulate the central nervous system, which may increase
wakefulness and reduce fatigue.
A placebo is not a drug. It looks like the study drug but is not designed to treat any
disease or illness. It is designed to be compared with a study drug to learn if the study
drug has any real effect.
If you are found eligible to take part in this study, you will be randomly assigned (as in
the flip of a coin) to 1 of 2 groups. Group 1 will take armodafinil. Group 2 will take a
placebo. A placebo is a substance that looks like the study drug but has no active
Neither you nor the study staff will know if you are receiving the study drug or the
placebo. However, if needed for your safety, the study staff will be able to find out what
you are receiving.
Study Drug Administration:
You will take the study drug/placebo every day for 4 weeks starting the morning after you
have enrolled in this study. You will take the study drug/placebo in the morning with a
full glass (8 ounces) of water. You may take the study drug/placebo with or without food.
If the dose causes an upset stomach, you should take it with food. If you have trouble
swallowing the dose of study drug/placebo, the study staff will tell you of different ways
of taking it. You will be given a pamphlet with more information about how to take the
Before you start taking the study drug/placebo, the following tests and procedures will be
-You will complete 6 questionnaires about your fatigue, sleepiness, and other symptoms as
well as your quality of life and your ability to work. These questionnaires should take
about 20 minutes to complete total.
Throughout the study, you will complete 2 of the symptom questionnaires listed above 2 times
every week while you are on study, including during the Open-label Extension Phase
(described below). You may complete the questionnaires over the phone using the Interactive
Voice Response (IVR) system or with a member of the study staff. Another option is to
complete the questionnaires during a routinely scheduled visit outside of this study. If you
complete the questionnaires over the phone, the study staff or the IVR system will call you
at a time that is convenient for you. If the questionnaires are completed through the IVR
system, the study staff will give you the information you need to report your symptoms by
using the system. If the questionnaires are completed with the study staff, she/he will ask
you the questions and record your answers on paper or enter them into a computer.
When you complete the questionnaires for the second time each week, you will also be asked
if you are taking your study drug/placebo as instructed and you will be asked about any side
effects you may be having. If the questionnaires were completed through the IVR system, the
study staff will contact you and ask you if you are taking your study drug/placebo as
instructed and about any side effects you may be having.
At the end of Week 4, you will complete the same set of 6 questionnaires that you completed
at the beginning of the study. You will also complete a questionnaire about your thoughts
on the study drug/placebo. You will also be asked about any changes in drugs (both
prescribed and over the counter) that you may be taking. This should take about 30 minutes.
At the end of Week 4, if you were in Group 1 and you did not have any intolerable side
effects, you will be able to continue taking armodafinil for an additional 4 weeks. If you
were in Group 2 and you did not have any intolerable side effects, you will be given the
option to begin receiving armodafinil for 4 weeks.
No matter what you choose, you will not be told whether you were taking the study drug or
the placebo during the first 4 weeks of the study.
If you are in the open-label extension phase, at the end of Week 8, you will complete the
same set of 6 questionnaires that you completed at the beginning of the study. You will also
complete a questionnaire about your thoughts on the study drug/placebo. This should take
about 30 minutes.
Length of Treatment:
You will receive the study drug/placebo for either 4 or 8 weeks. You will be taken off
study if intolerable side effects occur or if the study doctor thinks it is in your best
After your last dose of the study drug/placebo, you will continue to complete 2 symptom
questionnaires for another 4 weeks. The last time you complete the 2 questionnaires, you
will complete an additional 3 questionnaires that you completed at the beginning of the
This is an investigational study. Armodafinil is FDA-approved and commercially available to
treat narcolepsy (falling asleep at unexpected times), obstructive sleep apnea, and shift
work sleep disorder. It is also FDA-approved and commercially available to treat sleepiness
in patients with excessive sleepiness. Its use in this study is investigational.
Up to 40 patients will take part in this study. Up to 25 will be enrolled at MD Anderson.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Combined Patient-Reported Fatigue Scores
Combined 4-week area under the curve (AUC) for the patient-reported "fatigue at its worst" item from the Brief Fatigue Inventory - BFI using a 0 (no fatigue) to 10 scale (worst fatigue).
Gary B. Gunn, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
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