Breakthrough Dyspnea Fentanyl Study

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the flip of a coin) to either receive fentanyl or placebo. You will have an equal
chance of being assigned to either group.

Study Drug/Placebo Administration:

Before you receive the study drug/placebo, you will walk back and forth in an indoor
corridor for up to 6 minutes. You may feel out of breath or become exhausted. You may slow
down, stop, and rest at any time you need to.

After that, you will sit down and rest (for up to 1 hour). During this time, the study
drug/placebo will be prepared.

You will then be given a study drug/placebo shot under the skin in your arms or legs. You
will then wait for another 15 minutes and repeat the walking test.

Study Visit:

During your study visit, the study staff will collect information from your medical record
about your age, sex, race, disease type, how well you are able to perform the normal
activities of daily living, any drugs you are taking, and possible causes of shortness of
breath.

You will also complete 2 walking tests. Before the walk tests, you will complete 2
questionnaires. One (1) of them asks about any breathing symptoms you may be having, and
the other asks about any other symptoms you may be having. It should take about 10 minutes
to complete these questionnaires.

Before and after each walk test, the study staff will record your heart rate, breathing
rate, and the level of air breathed out using a measuring device that will be clipped onto
your finger. The study staff will also ask you questions about how hard it is to catch your
breath and your level of tiredness.

During each walk test, you will be asked about how hard it is to catch your breath. The
distance you walked and how often and for how long you stopped will be recorded. Before and
after the second walk test, the study staff will ask you about any side effects from the
study drug/placebo that you may be having.

During the rest period between the 2 walk tests, you may be asked how hard it is to catch
your breath several times.

At the end of the study visit, you will fill out 1 questionnaire that asks if you think the
study drug/placebo is helping you, and how satisfied you are with the study. It should take
about 5 minutes to complete the questionnaire.

Length of Study:

You will be on this study for up to 100 minutes.You will be taken off study if intolerable
side effects occur during the study.

This is an investigational study. Fentanyl is FDA approved and commercially available for
the treatment of pain. It's use to help with shortness of breath is investigational.

Up to 20 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Inclusion Criteria:

1. Diagnosis of cancer

2. Breakthrough dyspnea, defined in this study as dyspnea on exertion with an average
intensity level >=3/10 on the numeric rating scale

3. Outpatient or inpatient at MD Anderson Cancer Center seen by the Supportive Care or
Rehabilitation Service

4. Able to communicate in English or Spanish

5. Ambulatory and able to walk with or without walking aid

6. On strong opioids with morphine equivalent daily dose of 30-580 mg, with stable (i.e.
+/- 30%) regular dose over the last 24 hours

7. Karnofsky performance status >=50%

8. Age 18 or older

Exclusion Criteria:

1. Dyspnea at rest >=7/10 at the time of enrollment

2. Supplemental oxygen requirement >6 L per minute

3. Delirium (i.e. Memorial delirium rating scale >13)

4. History of unstable angina or myocardial infarction 1 month prior to study enrollment

5. Resting heart rate >120 at the time of study enrollment

6. Systolic pressure >180 mmHg or diastolic pressure >100 mmHg at the time of study
enrollment

7. History of active substance abuse within the past 12 months

8. History of allergy to fentanyl

9. Unwilling to provide informed consent