A Randomized, Double Blind, Two Period, Placebo-Controlled Crossover Trial of a Sustained Release Methylphenidate in the Treatment of Fatigue in Breast or Gastrointestinal Cancer Patients
OROS Methylphenidate HCl is a mild central nervous system stimulant. Cytokines are a type
of protein found in blood. Medical researchers here at M. D. Anderson are working to see if
they are related to, or can tell us something about, fatigue and its symptoms.
This study will be divided into two, 14-day periods. During one of the 14-day periods, you
will be given the study drug. During the other period, you will be given a placebo. A
placebo is a sugar tablet that looks just like the study drug tablet.
You will be randomly picked (as in the toss of a coin) to be in one of two treatment groups.
In one group you will receive the study drug first and the placebo second. In the other
group you receive the placebo first and the study drug second. The chance of being in either
treatment group is about equal. Neither you nor the research staff will know which
treatment order you are assigned to.
Before treatment starts, you will fill out questionnaires about your level of fatigue,
distress, symptoms, and general health. It should take about 5 minutes to complete the
questionnaires. You will have a medical history, physical exam (with pulse, temperature,
blood pressure), and blood work done. At the start of the study a test of the heart called
an EKG will be done. At the start of the study, and after you finish the study, you will
complete additional questionnaires that measure mood, fatigue, sleep, and appetite. It
should take about 15 minutes to complete the questionnaires. You will also complete a
series of tests for memory, visual-motor, and thinking functions. These tests should take
about 30 minutes to complete. (This evaluation may take place on or before Day 1 of the
On Day 1, a set of study medications and a diary will be given to you. For the first
fourteen days of the study, you will take the assigned study medication (either drug or
placebo). Everyday you will fill out the diary, noting the time you took the study
medication and answering two questions about your fatigue.
On Day 7, study personnel will see you in the clinic or Ambulatory Treatment Center. The
delegated research personnel will take your blood pressure and pulse and ask you about any
symptoms or complaints you may have had or any medications you may have taken.
On Day 14, study personnel will see you in the clinic or the Ambulatory Treatment Center
where blood pressure and pulse will be measured. Unused study medication will be returned
and your diary will be reviewed with the delegated research personnel. You will complete
questionnaires asking about fatigue, sleep, depression, and symptoms. It should take about
15 minutes to complete them. You will also complete a series of tests for memory,
visual-motor, and thinking functions. The tests should take about 30 minutes to complete. A
blood draw will be done to look for changes in hemoglobin and for cytokine analysis.
A new set of study medications and a diary will be given to you. You will follow the same
instructions as the first time period. You will take the assigned study medication every
morning and fill out the diary, noting the time you took the study medication and answering
two questions about your fatigue.
On Day 21, the same activities as Day 7 will occur.
If you are not scheduled to come to M. D. Anderson on Day 7 and Day 21, you will take 2
separate blood pressure measurements 5 minutes apart for each day and report results within
24 hours to the research staff. If you choose to take your blood pressure measurements at
home, you need to bring your monitor at study enrollment to have measurements double-checked
by research staff.
On Day 28, the study will end. The same activities as Day 14 will occur. In addition, you
will have a physical exam.
You will be asked if you prefer the first (first 2 weeks of study) or second (second 2 weeks
of study) treatment phase. If you want to continue taking the OROS Methylphenidate you will
be allowed to do so off-study as long as there are no medical reasons not to.
This is an investigational study. The study drug has been approved for attention-deficit
hyperactivity disorder but is investigational as a treatment for cancer related fatigue.
The study medication and physical exams will cost you nothing. You will be reimbursed with a
fixed amount of money for each scheduled study visit. The payment will be in the form of a
gift card for parking expenses and a gift card for gas expenses. The study doctor or study
staff can tell you more about when you will be able to receive reimbursement. A total of 50
patients will take part in this study. All will be enrolled at The University of Texas (UT)
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Mean Difference Between Post-Methylphenidate and Post-Placebo Measurement
The primary endpoint is the "fatigue worst" score (range: 0 - 10) on the Brief Fatigue Inventory (BFI) at the end of two-week treatment (either Methylphenidate or placebo). "Worst fatigue" is defined as participants' rating of worst fatigue on a scale of 0 (no fatigue) to 10 (as bad as can imagine). Since each participant is expected to receive both 2-week of Methylphenidate or 2-week placebo at different times, they serve as their own control. The outcome is the difference in "fatigue worst" score between post-Methylphenidate measurement and post-Placebo measurement.
At end of two 2-week treatment cycles (4 weeks total)
Carmen Escalante, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
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