A Preliminary Study of Prophylactic Fentanyl Buccal Tablets (FBT) for Exercise Induced Breakthrough Dyspnea
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. 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.
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
You will complete 2 questionnaires. One (1) of them will have questions 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.
The study staff will then record your vital signs (heart rate, breathing rate, and the level
of air breathed out using a measuring device that will be clipped onto your finger). You
will also be asked how hard it is to catch your breath and to rate your level of tiredness.
You will then walk back and forth in an indoor corridor for up to 6 minutes. This is called
a walk test. 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 and you may be asked several times how hard it is to catch
You will then be given a study drug/placebo tablet to put it in between your upper gum and
cheek. You will then wait for another 30 minutes, be asked about any side effects you may
be having, and repeat the walking test. Then the study staff will ask you again about any
side effects you may be having, your level of tiredness, and how hard it is to catch your
breath. Your vital signs will also be measured.
During each walk test, you will be asked 6 times how hard it is to catch your breath. How
often you stopped and for how long will be recorded. The total distance you walked will
also be recorded.
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, how satisfied you are with the study, and which treatment
you think you received. It should take about 5 minutes to complete the questionnaire.
Length of Study:
Your active participation in this study is over after you complete the last questionnaire.
You will be taken off study if intolerable side effects occur or if you are unable to follow
Thirty (30) days after your study visit you will be called by the study staff and asked how
you are feeling and about any side effects you may be having. This call should last about
This is an investigational study. Fentanyl is FDA approved and commercially available for
the treatment of pain. Its use to control shortness of breath is investigational.
Up to 20 participants will be enrolled in this study. All will take part at MD Anderson.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Variances of Change in Intensity of Exercise-Induced Breakthrough Dyspnea
Comparisons within arms performed using multiple linear regression based on the difference of the final dyspnea scores of the first and second walk tests. Baseline dyspnea and distance walked included as covariates. Size and significance of the difference in dyspnea determined by examination of the intercept.
David Hui, MD
M.D. Anderson Cancer Center
United States: Food and Drug Administration
|University of Texas MD Anderson Cancer Center||Houston, Texas 77030|