The Effect of Dexamethasone on Symptoms in Patients With Advanced Cancer
Dexamethasone decreases inflammation and also suppresses the immune system.
If you are found to be eligible for this study, you will be randomly assigned (as in the
toss of a coin) to receive either dexamethasone or a placebo by mouth in the morning and at
night with food every day for 14 days. A placebo is a substance that looks like the study
drug but which has no active ingredients. You will have an equal chance of being placed in
either of the 2 groups. You, the medical staff, and researchers will not know to which
group you have been assigned.
Beginning on Day 15 [± 3 days], regardless of if you were assigned to the dexamethasone or
placebo group during the first 14 days, you will begin receiving the dexamethasone. On Days
15-21, you will receive dexamethasone 2 times a day. On Days 22-28 you will continue to take
dexamethasone 2 times a day, but it will be at a lower dose level.
If you develop intolerable side effects while on this study, the medication will be stopped
and you will be removed from the study.
You will be asked to return to the outpatient clinic on Days 8 [± 3 days], 15 [± 3 days] ,
22 [± 3 days], and 29 [± 3 days] to answer a questionnaire about your cancer diagnosis, the
medication you are taking, and the symptoms you are having (for example, pain, fatigue,
nausea, appetite problems, sleep problems, depression, and your overall sense of
well-being). The questionnaire will take approximately 30 minutes to complete. Blood
(about 1 tablespoon) will be drawn to measure protein levels and to check the iron level in
your blood. If you are unable to return to the clinic on days 8, 15, 22, or 29; the
assessments will be done by the research nurse by phone; the blood work will not be done.
You will be considered off-study on Day 29 [ ± 3 days]. All study patients will have a 2
week follow-up on day 43 [± 3 days] after study drug has been discontinued, for safety and
toxicity assessments. If you are unable to return to the clinic on day 43, the research
nurse will do the safety and toxicity assessment by phone.
This is an investigational study. Dexamethasone 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 160 patients will take part in this study. Up
to 110 will be enrolled at M. D. Anderson. The other sites participating in this study are
Lyndon Baines Johnson [LBJ] breast oncology clinic Houston Texas, and Four Seasons Hospice
in Flat Rock, North Carolina.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Fatigue will be measured using the Functional Assessment for Chronic Illness Therapy-Fatigue (FACIT-F) on Days 8 [± 3 days], 15 [± 3 days] , 22 [± 3 days], and 29 [± 3 days].
Sriram Yennurajalingam, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|
|Lyndon Baines Johnson Hospital||Houston, Texas 77026|