Status:
COMPLETED
Fentanyl Pectin Nasal Spray (FNPS) for Exercise-Induced Breakthrough Dyspnea
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Depomed
Conditions:
Advanced Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 com...
Detailed Description
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 receive either fentanyl or placebo. You will have an equal chance...
Eligibility Criteria
Inclusion
- Diagnosis of cancer
- Breakthrough dyspnea, defined in this study as dyspnea on exertion with an average intensity level \>=3/10 on the numeric rating scale
- Outpatient at MD Anderson Cancer Center seen by the Supportive Care Service or Thoracic Medical Oncology
- Ambulatory and able to walk with or without walking aid
- On strong opioids with morphine equivalent daily dose of 80-500 mg, with stable (i.e. +/- 30%) regular dose over the last 24 hours
- Karnofsky performance status \>=50%
- Age 18 or older
- Able to complete study assessments
Exclusion
- Dyspnea at rest \>=7/10 at the time of enrollment
- Supplemental oxygen requirement \>6 L per minute
- Delirium (i.e. Memorial delirium rating scale \>13)
- History of unstable angina or myocardial infarction 1 month prior to study enrollment
- Resting heart rate \>120 at the time of study enrollment
- Systolic pressure \>180 mmHg or diastolic pressure \>100 mmHg at the time of study enrollment
- History of active opioid abuse within the past 12 months
- History of allergy to fentanyl
- Unwilling to provide informed consent
- Patients who currently have no evidence of disease
Key Trial Info
Start Date :
June 11 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 25 2019
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT01832402
Start Date
June 11 2013
End Date
November 25 2019
Last Update
June 8 2023
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030