Status:
COMPLETED
Breakthrough Dyspnea Fentanyl Study in Cancer Patients
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Advanced Cancers
Dyspnea
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 p...
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
- Breakthrough dyspnea, defined in this study as dyspnea on exertion with an average intensity level \>=3/10 on the numeric rating scale
- Outpatient or inpatient at MD Anderson Cancer Center seen by the Supportive Care or Rehabilitation Service
- Able to communicate in English or Spanish
- Ambulatory and able to walk with or without walking aid
- On strong opioids with morphine equivalent daily dose of 30-580 mg, with stable (i.e. +/- 30%) regular dose over the last 24 hours
- Karnofsky performance status \>=50%
- Age 18 or older
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 substance abuse within the past 12 months
- History of allergy to fentanyl
- Unwilling to provide informed consent
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2013
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01515566
Start Date
April 1 2012
End Date
April 1 2013
Last Update
August 22 2014
Active Locations (1)
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1
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030