Trial of Dexamethasone for Dyspnea in Cancer Patients

If you are found to be eligible to take part in this study, you will have baseline tests
after completing the screening questionnaires. The following tests and procedures will be
performed:

- Your breathing rate will be measured.

- The amount of oxygen in your body will be measured using a machine that clips on your
finger.

- You will blow into a device called a spirometer a few times to measure your lung
function.

- You will be asked to complete 4 questionnaires about shortness of breath, symptoms, and
quality of life. These questionnaires should take a total of about 30 minutes to
complete.

- Blood (about 1 tablespoon) will be drawn for cytokine testing. Cytokines are proteins
that may affect the immune system.

Study Groups:

You will be randomly assigned (as in a roll of dice) to 1 of 2 study groups:

- If you are in Group 1, you will receive dexamethasone on Days 1-14 of the study.

- If you are in Group 2, you will receive a placebo on Days 1-14 of the study.

This is done because no one knows if one study group is better, the same, or worse than the
other group. You will have a 2 in 3 chance of being assigned to Group 1. You will have a 1 in
3 chance of being assigned to Group 2.

Neither you nor the study staff will know if you are receiving the study drug or the placebo.
However, if needed for your safety, the study staff will be able to find out what you are
receiving.

After 14 days, no matter which group you are assigned to, you will take dexamethasone for 14
days.

Study Drug/Placebo Administration:

On Days 1-7, you will take 2 dexamethasone or placebo capsules twice each day.

On Days 8-14, you will take 1 dexamethasone or placebo capsule twice each day.

On Days 15-28, you will take 1 dexamethasone capsule twice each day.

You should take the capsules around 8:00 AM and 4:00 PM. You should take the capsules with
food and about a cup (8 ounces) of water.

Study Visits/Calls:

Beginning the day before you start taking dexamethasone (Day 0) through Day 14, you will be
called 1 time each day to ask you about your level of shortness of breath and to remind you
to take the capsules. These calls should last about 5 minutes each time.

On or about Days 7 and 14, you will return to the clinic. You should bring your capsule boxes
with you when you come to the clinic so the study staff can count the number of capsules. The
following tests and procedures will be performed:

- You will be asked to complete the same 4 questionnaires you completed during your
baseline tests. These questionnaires should take a total of about 30 minutes to
complete.

- You will blow into a spirometer to measure your lung function.

- You will be asked if you know if you have been receiving dexamethasone or placebo.

- Blood (about 1 tablespoon) will be drawn for cytokine testing. Cytokines are proteins
that may affect the immune system.

On Day 14, you will be asked at what level of shortness of breath you would feel comfortable.

You will be called on or about Days 28 and 42 to ask you about your level of shortness of
breath and any side effects you may be having. This call should last about 5 minutes.

Length of Study:

You will be on study for 42 days. You will no longer be able to take the study drug/placebo
if intolerable side effects occur or if you are unable to follow study directions.

Your participation on the study will be over after your last visit/call.

Inclusion Criteria:

1. Diagnosis of cancer

2. Dyspnea with an average intensity >/=4 on the dyspnea NRS (range 0-10) over the past
week

3. Radiologic suspicion of thoracic involvement, such as primary or metastatic lung
cancer, lymphangitic carcinomatosis, airway infiltration, lymphadenopathy, pleural or
chest wall invasion

4. Seen at an outpatient clinic at MD Anderson Cancer Center or LBJ Hospital General
Oncology Clinic

5. Able to communicate in English or Spanish

6. Karnofsky performance status >/=30%

7. Age 18 years or older

Exclusion Criteria:

1. Delirium (i.e., score >13 on the Memorial Delirium Assessment Scale; range 1-30)

2. Oxygen saturation <90% despite supplemental oxygen >6 L/minute

3. Previous allergic reactions to dexamethasone

4. Diagnosis of diabetes mellitus uncontrolled with oral hypoglycemic agents or insulin

5. Postsurgical open wound that has not healed at the time of enrollment

6. Any infection requiring antibiotics within the past 2 weeks

7. Major surgery within the past 2 weeks

8. Megestrol use at the time of study enrollment

9. Neutropenia (absolute neutrophil count <1.0 × 109/L) at the time of study enrollment
(bloodwork is not required if patient did not have chemotherapy within past 2 weeks)

10. Currently receiving or expected to start cytotoxic chemotherapy or immunotherapy
within 1 week of study enrollment and additional dexamethasone cannot be used
concurrently as per attending oncologist

11. Severe anemia (hemoglobin <8 g/L) not corrected prior to study enrollment (bloodwork
is not required if patient did not have chemotherapy within past 2 weeks)

12. COPD exacerbation at the time of study enrollment

13. Heart failure exacerbation at the time of study enrollment

14. Expected to undergo therapeutic thoracentesis in the next 2 weeks

15. High anxiety score (>/=15/21) on the Hospital Anxiety and Depression Scale (HADS)

16. Chronic systemic corticosteroid use (>14 days) at the time of study enrollment

17. Any expected corticosteroid use during study enrollment at higher doses than will be
used in this study