Clinical trial NCT01169753
Conditions: Chronic Myeloid Leukemia
Keywords: Chronic Myeloid Leukemia CML Nuvigil Armodafinil Fatigue
Sponsor: M.D. Anderson Cancer Center
Start date: 2011-05-01; Completion date: 2013-02-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The goal of this clinical research study is to learn if Nuvigil (armodafinil) can help to control fatigue in patients with CML. The safety of this drug will also be studied.

Detailed description:
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.

Arms: arm 1: Patients randomized to nonintervention will take a placebo every morning for 2 weeks. arm 2: Three 50 mg tablets orally every morning for 2 weeks.
Interventions: intervention 1: Placebo intervention 2: Armodafinil
Intervention descriptions: intervention 1: Oral tablet every morning for 2 weeks intervention 2: Three 50 mg tablets orally every morning for 2 weeks.

Protocol documents: