Overview

Breakthrough Dyspnea Fentanyl Study in Cancer Patients

Status:
Completed
Trial end date:
2013-04-01
Target enrollment:
0
Participant gender:
All
Summary
The goal of this clinical research study is to learn if fentanyl given under the skin can reduce shortness of breath in cancer patients. Researchers also want to learn if it can help to improve your physical function. In this study, fentanyl will be compared to a placebo. Fentanyl is commonly used for treatment of cancer pain. It is believed to help patients with their shortness of breath as well. A placebo is not a drug. It looks like the study drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
M.D. Anderson Cancer Center
Treatments:
Fentanyl
Criteria
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