Fentanyl Buccal Tablets for Exercise Induced Breakthrough Dyspnea

Completed · Phase 2 · Has a placebo group

Conditions studied: Advanced Cancers

In brief

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 your physical function. In this study, fentanyl will be compared to a placebo. Fentanyl is commonly used for treatment of cancer pain. 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.

Key facts

Study ID

NCT01856114

Run by

M.D. Anderson Cancer Center

People needed

36

Starts

2014-05-27

Expected to finish

2019-12-04

Last updated by the study team

2020-09-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Texas MD Anderson Cancer Center — Houston, Texas, United States

Full record on ClinicalTrials.gov

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