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The Effect of Dexamethasone on Symptoms in Patients With Advanced Cancer

Phase 2
18 Years
Open (Enrolling)
Solid Tumors

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Trial Information

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.

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 MDAS score of 13 or less at

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 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Cancer-Related Fatigue

Outcome Description:

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].

Outcome Time Frame:


Safety Issue:


Principal Investigator

Sriram Yennurajalingam, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

February 2006

Completion Date:

Related Keywords:

  • Solid Tumors
  • Advanced Cancer
  • Solid Tumors
  • Fatigue
  • Pain
  • Nausea
  • Anorexia
  • Dexamethasone
  • Decadron
  • Placebo
  • Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030
Lyndon Baines Johnson Hospital Houston, Texas  77026