Trial Information

A Randomized Controlled Trial of Methylphenidate and a Nursing Telephone Intervention (NTI) for Fatigue in Advanced Cancer Patients

Fatigue is one of the most common problems in patients with advanced cancer. Currently,
there are no treatments for managing fatigue. Methylphenidate is a stimulant that increases
ability to pay attention, increases mental alertness, and decreases feelings of fatigue.

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the roll of dice) to one of 4 groups. You will have an equal chance of being placed
in any of the 4 groups. You, the medical staff, and researchers will not know to which
group you have been assigned.

Regardless of which group you are in, you will record your fatigue in a daily diary at
breakfast, lunch, dinner, and before bedtime. Based on your level of fatigue, you will take
the study drug as needed. You can take the study drug every 2 hours but you may not take
more than 4 capsules a day.

Participants in Group 1 will take a methylphenidate capsule by mouth as needed to relieve
symptoms of fatigue for 14 days. A nurse will call you 4-6 times in the first two weeks
to ask about side effects and other symptoms. The phone calls should take about 10-20
minutes. The study nurse will set up a convenient time for you to take the phone call.

Participants in Group 2 will take a placebo capsule by mouth as needed for 14 days. A
placebo is a capsule that does not contain any medication but looks just like the
methylphenidate. A nurse will call you 4-6 times in the first two weeks to ask about side
effects and other symptoms. The phone calls should take about 10-20 minutes. The study nurse
will set up a convenient time for you to take the phone call.

Participants in Group 3 will take a methylphenidate capsule by mouth as needed for 14 days.
Participants in this group will not receive any calls from a study nurse. However, A
research staff member will call you 4-6 times in the first two weeks to ask about side
effects and other symptoms. The phone calls should take about 10-20 minutes. The research
staff member will set up a convenient time for you to take the phone call.

Participants in Group 4 will take a placebo capsule by mouth as needed for 14 days.
Participants in this group will not receive any calls from a study nurse. However, A
research staff member will call you 4-6 times in the first two weeks to ask about side
effects and other symptoms. The phone calls should take about 10-20 minutes. The research
staff member will set up a convenient time for you to take the phone call.

You will be asked to wear a wrist actigraph monitor (a wristwatch that keeps track of your
physical activity and your sleep cycles) for the first 14 days.

You will keep a daily diary of your fatigue and other symptoms, the number and times pills
are taken, and your fatigue rating before and 2 hours after taking methylphenidate.

On about day 15 (or within 3 days) you will return to the palliative care clinic at M. D.
Anderson for tests. You will be asked about your level of drowsiness, pain, constipation,
and fatigue. You will be asked about any side effects you may have experienced and the
effectiveness of the drug. You will repeat the 6 minute physical test, the cognitive status
test, and you will return the actigraph monitor to the research nurse. You will also be
given the option to receive up to 4 capsules of methylphenidate per day until Day 36. You
will not be told whether you were taking placebo or methylphenidate during Days 1-14. If
you cannot come to the clinic on Day 15, all tests except the walking test, may be performed
over the telephone. You will be asked to mail the actigraph back.

If you decide not to take methylphenidate on Days 15-36, you will be considered off-study
and you will have end-of-study tests on Day 15. If you decide to take methylphenidate on
Days 15-36, you will remain on study until Day 36. On Day 36, you will have end-of-study
tests.

For end-of-study tests, you will repeat the physical and cognitive tests. You will be
asked about your symptoms and any side effects you may be experiencing. You will then return
to your primary physician who will discuss with you whether or not to continue on the
methylphenidate based on your response to the drug.

Your participation in this study should end on either Day 15 or Day 36. However, if you
develop intolerable side effects (including fatigue) while on this study, the medication
will be stopped and you will be removed from the study.

This is an investigational study. Methylphenidate has been approved by the FDA and is a
commercially available drug. It is FDA approved at this dose level. Its use in this study,
for this purpose, is investigational. About 212 patients will take part in this multicenter
study. About 142 patients will be enrolled at M. D. Anderson.