Dexamethasone for Symptom Burden in Advanced Cancer Patients

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 the University of Texas (UT) MD Anderson Cancer Center. 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.

Inclusion Criteria:

1. Present with 3 or more symptoms during the last 24 hours (Pain, fatigue, chronic
nausea, and anorexia/cachexia, sleep problems, depression or poor appetite), with an
average intensity of >/= 4 on a 0-10 scale, in which 0= no symptom, and 10= worst
possible symptom,

2. No clinical evidence of cognitive failure as evidenced by Memorial Delirium Assessment
Scale (MDAS) score of 13 or less at baseline

3. Must be 18 years of older

4. No longer a candidate for aggressive anticancer therapy-such as receptor blockers
(Iressa, etc.) Patients on oral or palliative chemotherapy are eligible for study if
approved by primary oncologist prior to inclusion. Patients who are receiving IV
chemotherapy are eligible for study if approved by primary oncologist and they have
completed 1st line of chemotherapy and are deemed stable by primary oncologist. The PI
of this study will obtain and document approval from the primary oncologist in the
patient's study documents.

5. Life expectancy =/> 30 days

6. Must understand and sign written informed consent

7. Patients on topical, or inhaled corticosteroids are eligible for study. If patients
have been on oral corticosteroids for eligible for study.

Exclusion Criteria:

1. Allergy to Dexamethasone

2. Inability to complete the baseline assessment forms

3. Patients currently taking Megestrol, and not off drug for > 7 days

4. Anemia as defined as < 9 hemoglobin

5. Known history of human immunodeficiency virus (HIV)

6. Neutropenia as defined by an absolute neutrophil count (ANC) of < 1500 cells/mm

7. Patients with a history of diabetes will be excluded.

8. All major surgeries such as thoracotomy etc., that requires wound healing within last
2 weeks

9. Those who are currently receiving oral corticosteroid therapy or who have been on
corticosteroid therapy >/= 8 days prior to study inclusion

10. Sepsis and/or acute, chronic, or ongoing infections