Status:
COMPLETED
Fentanyl Buccal Tablets for Exercise Induced Breakthrough Dyspnea
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Teva Pharmaceuticals USA
Conditions:
Advanced Cancers
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this clinical research study is to learn if fentanyl can change perception of shortness of breath in cancer patients. Researchers also want to learn if the study drug can help to improve y...
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 either receive fentanyl or placebo. You will have an equal chance...
Eligibility Criteria
Inclusion
- Diagnosis of cancer with evidence of active disease
- 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, Thoracic Medical Oncology or Cardiopulmonary Center
- Ambulatory and able to walk with or without walking aid
- On strong opioids with morphine equivalent daily dose of 60-130 mg for at least one week, 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
- Must speak and understand English.
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
- Severe anemia (Hb \<7g/L) if documented in the last month and not corrected prior to study enrollment\*
- Bilirubin \>5X Upper limit of normal if documented in the last month and not lowered to \<5x normal prior to study enrollment\*
- Diagnosis of acute pulmonary embolism within past 2 weeks
- Diagnosis of pulmonary hypertension
- Unwilling to provide informed consent
Key Trial Info
Start Date :
May 27 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 4 2019
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01856114
Start Date
May 27 2014
End Date
December 4 2019
Last Update
September 16 2020
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030