Phase 3
N=34
Fentanyl Sublingual Spray for Exercise-Induced Breakthrough Dyspnea
Advanced Cancers
Bottom Line
View on ClinicalTrials.gov: NCT02597478 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Modified Dyspnea Borg Scale (Dyspnea Intensity) — -1.4; -0.5 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fentanyl Sublingual Spray (Drug); Shuttle Walk Test (Procedure); Questionnaires (Behavioral); Mental Ability Tests (Behavioral); Phone Call (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Sep 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Modified Dyspnea Borg Scale (Dyspnea Intensity) |
-1.4; -0.5 | — |
| SECONDARY Modified Dyspnea Borg Scale (Dyspnea Unpleasantness) |
-1.0; -0.6 | — |
| SECONDARY Walk Distance |
43.7; 24.2 | — |
| SECONDARY Walk Time |
0.5; 0.3 | — |
| SECONDARY Fatigue Modified Borg Score |
-1.0; 0.2 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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 /=50%
- Age 18 or older
- Able to complete study assessments
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02597478). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.