Fentanyl Sublingual Spray for Exercise-Induced Breakthrough Dyspnea

Completed · Phase 2/Phase 3

Conditions studied: Advanced Cancers

In brief

The goal of this clinical research study is to learn if fentanyl can help shortness of breath in cancer patients. Researchers also want to learn if the study drug can help to improve your physical function.

Key facts

Study ID

NCT02597478

Run by

M.D. Anderson Cancer Center

People needed

50

Starts

2016-01-04

Expected to finish

2021-01-27

Last updated by the study team

2021-02-09

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 as dyspnea with an average intensity level over the past 7 days of at least 3/10 on a numeric rating scale upon significant exertion or continuous dyspnea </=7/10 with worsening upon significant exertion
• Outpatient at MD Anderson Cancer Center seen by the Supportive Care Service, Thoracic Medical Oncology, Cancer Pain Clinic, or Cardiopulmonary clinic
• Ambulatory and able to walk with or without walking aid
• On strong opioids with morphine equivalent daily dose of 80-500 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

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*
• 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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