Phase 2 N=35 Randomized Double-blind Supportive Care

Fentanyl Pectin Nasal Spray (FNPS) for Exercise-Induced Breakthrough Dyspnea

Advanced Cancers

Bottom Line

View on ClinicalTrials.gov: NCT01832402 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2020

Primary outcome: Primary: Dyspnea Numeric Rating Scale — -2.0; -1.7; -2.3; -2.5 score on a scale

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Fentanyl Pectin Nasal Spray (Drug); Placebo Nasal Spray (Drug); Walk Test (Other); Questionnaires (Behavioral); Mental Ability Tests (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: M.D. Anderson Cancer Center
Primary completion: Nov 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Dyspnea Numeric Rating Scale	-2.0; -1.7; -2.3; -2.5	—
SECONDARY Dyspnea Borg Scale	-1.8; -1.7; -1.7; -2.4	—
SECONDARY Walk Distance at 6 Minutes	23.8; 16.3; 23.3; 14.6	—

Summary

The goal of this clinical research study is to learn if fentanyl nasal spray can help to control shortness of breath in patients who have been treated or are being treated for cancer. Fentanyl is commonly used for treatment of cancer pain. It may help patients with their shortness of breath as well. In this study, fentanyl will be compared to a placebo. 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.

Eligibility Criteria

Inclusion Criteria

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 at MD Anderson Cancer Center seen by the Supportive Care Service or Thoracic Medical Oncology
Ambulatory and able to walk with or without walking aid
On strong opioids with morphine equivalent daily dose of 80-500 mg, 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

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
Unwilling to provide informed consent
Patients who currently have no evidence of disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01832402). 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.