Nuvigil in Treatment of Cancer-Related Fatigue in Chronic Myeloid Leukemia (CML) on Imatinib, Dasatinib, Nilotinib (or Any Other FDA Approved TKI for CML)
The Study Drug:
Armodafinil is designed to help promote wakefulness in patients suffering from fatigue.
Study Groups:
If you are found to be eligible to take part in this study, you will take 3 tablets each day
during Weeks 1, 2, 4, and 5. You will not take any tablets during Week 3.
You will be randomly assigned (as in the flip of a coin) to a study group. The tablets you
receive will depend on which study group you are in. You will have an equal chance of being
assigned to either group:
- If you are in Group 1, you will take armodafinil during Weeks 1 and 2 and a placebo
during Weeks 4 and 5. A placebo is a tablet that looks like the study drug but has no
active ingredients.
- If you are in Group 2, you will take a placebo during Weeks 1 and 2 and armodafinil
during Weeks 4 and 5.
Neither you nor the study staff will know to which group you are assigned. However, if
needed for your safety, the study staff will be able to find out what you are receiving at
any time.
You will be given a fatigue diary and a drug diary. You will fill out the fatigue diary
every day by answering 2 questions about fatigue. You will fill out the drug diary every
day by writing when you take the study drug/placebo. You will return any unused
drug/placebo at the end of Weeks 2 and 5.
At Week 5, you will be asked if you preferred the first period (Weeks 1 and 2 of the study)
or the second period (Weeks 4 and 5 of the study). If your doctor thinks it is in your
best interest and you are benefitting at this point, you will be able to continue taking the
study drug and you will have additional study visits.
If you are one of the patients selected for the PK testing, the final results of the PK
testing for your entire group will need to be completed before you can start the long term
use of the study drug. If you take the study drug after Week 5, you will take 3 tablets
every day for the rest of the time that you take the study drug.
Study Visits:
At the end of Weeks 1, 3, and 4:
- You will be asked about any symptoms that you may be having and about any other drugs
that you may be taking.
- You will complete 2 questionnaires about fatigue and activity. It will take about 10
minutes to complete these questionnaires.
- Your blood pressure will be measured (Weeks 1 and 4 only).
At the end of Weeks 2 and 5:
- You will have a physical exam, including measurement of your weight and vital signs.
- You will complete the same questionnaires you completed at screening.
- Blood (about 1 teaspoon) will be drawn for routine tests.
- If you were selected for PK testing during screening, you will also have PK blood
samples drawn at the end of Week 2 and Week 5.
- You will complete the series of tests that check your memory, motor skills, and
thinking that you completed at screening.
At Weeks 10, 15, 20, and 25:
- You will be asked about any symptoms that you may be having and about any other drugs
that you may be taking.
- You will complete the 2 questionnaires about fatigue and activity.
- Your blood pressure will be measured.
If you are not scheduled to come to MD Anderson at Weeks 1, 3, 4, 10, 15, 20, and 25, the
procedures to be performed at these times can be performed at home. You will be called and
asked the questions described in these visits. You will take 2 separate blood pressure
measurements 5 minutes apart for each day and report results to the research staff over the
telephone. If you choose to take your blood pressure measurements at home, you will be
provided with a home blood pressure monitor at screening and taught how to use it. The
monitor will be returned to study staff at the end of the study.
Length of Study:
You may continue taking the study drug as part of this study for up to 24 weeks. If you are
benefiting after 24 weeks, you may continue taking the study drug off study. If you are one
of the patients selected for the PK testing, the final results of the PK testing for your
entire group will need to be completed before you can start the long term use of the study
drug. You will be taken off study at any time if you have intolerable side effects or if
the study doctor thinks it is in your best interest.
End of Treatment:
About 6 months after the end of Week 5, the following tests and procedures will be
performed:
- You will complete the same questionnaires you completed at screening.
- You will complete the series of tests that check your memory, motor skills, and
thinking that you completed at screening.
- Blood (about 1 teaspoon) will be drawn for routine tests.
- You will have a physical exam, including measurement of your weight and vital signs.
Follow-Up:
The study staff will call you about 30 days after your last dose of study drug and ask about
any symptoms or complaints you may have had, as well as about any other drugs you may be
taking. This call will last about 10 minutes.
This is an investigational study. Armodafinil is FDA approved and commercially available to
help improve wakefulness in adults who experience excessive sleepiness. Its use in
cancer-related fatigue is investigational.
Up to 60 patients will take part in this study. All will be enrolled at MD Anderson.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Number of Patients with "Fatigue Worst" BFI Score
Efficacy defined by "fatigue worst" score from the Brief Fatigue Inventory (BFI) after each 2-week treatment period, using a 0 - 10 scale with 10 being WORST level of fatigue.
After each 2 week treatment
No
Carmen Escalante, MD
Study Chair
UT MD Anderson Cancer Center
United States: Food and Drug Administration
2009-0638
NCT01169753
May 2011
Name | Location |
---|---|
UT MD Anderson Cancer Center | Houston, Texas 77030 |