Overview

Fentanyl Pectin Nasal Spray (FNPS) for Exercise-Induced Breakthrough Dyspnea

Status:
Completed

Trial end date:
2019-11-25

Target enrollment:
0

Participant gender:
All

Summary

The goal of this clinical research study is to learn if fentanyl nasal spray can help to control shortness of breath in patients who have been treated or are being treated for cancer. Fentanyl is commonly used for treatment of cancer pain. It may help patients with their shortness of breath as well. In this study, fentanyl will be compared to a placebo. 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 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

M.D. Anderson Cancer Center

Collaborator:

Depomed

Treatments:

Fentanyl
Pectin

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 at MD Anderson Cancer Center seen by the Supportive Care Service or
Thoracic Medical Oncology

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

5. On strong opioids with morphine equivalent daily dose of 80-500 mg, with stable (i.e.
+/- 30%) regular dose over the last 24 hours

6. Karnofsky performance status >=50%

7. Age 18 or older

8. Able to complete study assessments

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 opioid abuse within the past 12 months

8. History of allergy to fentanyl

9. Unwilling to provide informed consent

10. Patients who currently have no evidence of disease